The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age. All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
105
monovalent pneumococcal conjugate candidate
monovalent pneumococcal conjugate control
FVR, Kokkolan rokotetutkimusklinikka
Kokkola, Keski-Pohjanmaa, Finland
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia, Finland
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, Finland
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 0 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, severe: \>7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 0 to 2.0 cm, moderate: \>2.0 to 7.0 cm, severe: \>7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever (oral temperature \>= 38 degree Celsius \[degC\]) was categorized as \>=38.0-38.4 degC, \>38.4-38.9 degC, \>38.9-40.0 degC and \>40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.
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FVR, Seinäjoen rokotetutkimusklinikka
Seinäjoki, South Ostrobothnia, Finland
FVR, Turun rokotetutkimusklinikka
Turku, Southwest Finland, Finland
FVR, Espoon rokotetutkimusklinikka
Espoo, Uusimaa, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa, Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, Uusimaa, Finland
FVR, Järvenpään rokotetutkimusklinikka
Jarvenpaa, Uusimaa, Finland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
...and 1 more locations
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever (oral temperature \>= 38 degC) was categorized as \>=38.0-38.4 degC, \>38.4-38.9 degC, \>38.9-40.0 degC and \>40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)
Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Time frame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator.
Time frame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution).
Time frame: 1 month after Dose 1
GMCs of Pneumococcal IgG at 1 Month After Dose 2
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution).
Time frame: 1 month after Dose 2
Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1
Predefined IgG concentrations was \>= 0.35 micrograms per milliliter (mcg/mL).
Time frame: 1 month after Dose 1
Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2
Predefined level of IgG concentrations was \>= 0.35 mcg/mL.
Time frame: 1 month after Dose 2
Geometric Mean Fold Rise (GMFRs) of Pneumococcal IgG From Before Dose 1 to 1 Month After Dose 1
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: From before Dose 1 to 1 month after Dose 1
GMFRs of Pneumococcal IgG From 1 Month After Dose 1 to 1 Month After Dose 2
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: From 1 month after Dose 1 to 1 month after Dose 2
Geometric Mean Titer (GMTs) of Pneumococcal Opsonophagocytic Activity (OPA) at 1 Month After Dose 1
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Time frame: 1 month after Dose 1
GMTs of Pneumococcal OPA at 1 Month After Dose 2
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Time frame: 1 month after Dose 2
GMFRs of Pneumococcal OPA From Before Dose 1 to 1 Month After Dose 1
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: From before Dose 1 to 1 month after Dose 1
GMFRs of Pneumococcal OPA From 1 Month After Dose 1 to 1 Month After Dose 2
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: From 1 month after Dose 1 to 1 month after Dose 2