This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
124
Intramuscular Injection
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 Evaluable Immunogenicity population (EIP).
Time frame: 1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Time frame: 1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
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Ochsner Clinic Foundation
Jefferson, Louisiana, United States
Ochsner Medical Center - Jefferson Highway
Jefferson, Louisiana, United States
Ochsner Clinic Foundation
Kenner, Louisiana, United States
Ochsner Medical Center Kenner
Kenner, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana, United States
Henry Ford Health System
Detroit, Michigan, United States
Henry Ford Hospital - Research Pharmacy
Detroit, Michigan, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
...and 19 more locations
Time frame: 1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 3 EIP.
Time frame: 1 Month after Vaccination 3
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Time frame: 1 Month after Vaccination 4
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Time frame: 1 Month after Vaccination 4
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP.
Time frame: 1 Month after Vaccination 4
GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Assay results below lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Participants who had no serological or virological evidence (prior to the subsequent blood sample collection) of past SARS-CoV-2 infection (i.e, negative N-binding antibody \[serum\] result at any visit prior to subsequent time point, SARS-CoV-2 not detected by NAAT \[nasal swab\] until prior vaccination, and negative NAAT \[nasal swab\] result at any unscheduled visit prior to subsequent blood sample collection) and had no medical history of COVID-19 were included in the analysis. Analysis was performed in Dose 4 EIP .
Time frame: 1 Month after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Local reactions were collected in an electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Redness and swelling were measured and recorded in measuring device units (mdu) where, 1 mdu =0.5 centimeter (cm) and were graded as mild (\>0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Local reactions collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate(\>2.0 to 7.0 cm), severe(\>7.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis\[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity),Grade 4(ER visit or hospitalization for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild \>2.0 to 5.0 cm), moderate(\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity) and Grade 4(ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\>0.5 to 2.0 cm),moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4(necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination 4. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 degree C (deg C); categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 1. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 1
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 2. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 2
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 3. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 3
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 de, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination 4. Fever was defined as oral temperature \>=38.0 deg C; categorised as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours, moderate: \>2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Time frame: Day 1 to Day 7 after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 1 to 1 month after Vaccination 2
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 3 to 1 month after Vaccination 3
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this outcome measure. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Vaccination 4 to 1 month after Vaccination 4
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)