The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age. This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
323
Two intramuscular injections
Two intramuscular injections
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 21
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 21
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 21
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 42
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
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GSK Investigational Site
Conway, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Arkansas City, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Saint Paul, Minnesota, United States
GSK Investigational Site
Omaha, Nebraska, United States
...and 20 more locations
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 42
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 21
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 21
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 21
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 42
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 42
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 42
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 42
Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - First Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - Second Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - First Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0 (PRE) and at Day 42
Number of Seropositive Subjects for HI Antibodies - Second Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0 (PRE) and at Day 42
Number of Seropositive Subjects for HI Antibodies
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0 (PRE) and at Day 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 182
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time frame: At Day 182
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time frame: At Day 0 (PRE) and at Day 182
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 182
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time frame: At Day 0 (PRE) and at Day 21
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time frame: At Day 0 (PRE) and at Day 42
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time frame: At Day 0 (PRE) and at Day 42
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time frame: At Day 0 (PRE) and at Day 21
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.
Time frame: At Day 0 (PRE) and at Day 42
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Haematological Laboratory Abnormalities
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 182
Number of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time frame: At Day 182
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 42 days (Days 0-41) post vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 41 days (Days 0-40) post vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 84 days (Days 0-83) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: Within 41 days (Days 0-40) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: Within 42 days (Days 0-41) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: Within 182 days (Days 0-181) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: Throughout the entire study period (Day 0 - Day 385)
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: Within 21 days (Days 0-20) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: Within 42 days (Days 0-41) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: Within 42 days (Days 0-41) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: Within 182 days (Days 0-181) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: Throughout the entire study period (Day 0 - Day 385)
Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Serious Adverse Events (SAEs) - First Analysis
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Within 42 days (Days 0-41) post vaccination
Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Within 42 days (Day 0-41) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Within 182 days (Days 0-181) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the entire study period (Day 0 - Day 385)