20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 20-valent pneumococcal conjugate vaccineBiological: 13-valent pneumococcal conjugate vaccine
- Registration Number
- NCT04546425
- Lead Sponsor
- Pfizer
- Brief Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1258
- Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- Major known congenital malformation or serious chronic disorder.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine
- Primary Outcome Measures
Name Time Method Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population Within 7 Days after Dose 2 Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population Within 7 days after Dose 3 Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population Within 7 Days after Dose 1 Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population Within 7 days after Dose 1 Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population Within 7 days after Dose 2 Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population From Dose 1 to 1 month after Dose 3 A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population From Dose 1 to 1 month after Dose 3 A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population 1 month after Dose 2 Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Assay result below LLOQ was set to 0.5\*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort Within 7 days after Dose 1 Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population Within 7 Days after Dose 3 Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: 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 with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population From Dose 1 to 1 month after Dose 2 An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population 1 month after Dose 3 Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5\*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort Within 7 days after Dose 3 Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort Within 7 Days after Dose 3 Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.
Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population From Dose 3 to 1 month after Dose 3 An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population 1 month after Dose 3 Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units \[IU\]) to diphtheria \& tetanus toxoid (prespecified level\>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level \>=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level \>=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: \>=1:8; Hemophilus influenzae type b(Hib): prespecified level \>=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.
GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population 1 month after Dose 3 Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population 1 month after Dose 3 Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population 1 month after Dose 3 Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort Within 7 Days after Dose 1 Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature \>=38.0 degree C \& categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort Within 7 Days after Dose 2 Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.
Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort From Dose 3 to 1 month after Dose 3 An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population 1 month after Dose 2 Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per mL (mcg/mL), for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population 1 month after Dose 3 Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort Within 7 days after Dose 2 Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort 1 month after Dose 2 Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B. \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort 1 month after Dose 3 Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort From Dose 1 to 1 month after Dose 2 An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort From Dose 1 to 1 month after Dose 3 A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort From Dose 1 to 1 month after Dose 3 A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort 1 month after Dose 2 Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population 1 month after Dose 2 OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population 1 Month after Dose 3 OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population Before Dose 3 to 1 month after Dose 3 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population 1 Month after Dose 3 Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population 1 month after Dose 2 Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration of antibody (in international units \[IU\]) to diphtheria and tetanus toxoid (prespecified level \>= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer \>=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level \>=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort 1 Month after Dose 3 Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort 1 month after Dose 2 OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort 1 Month after Dose 3 OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.
Trial Locations
- Locations (66)
Perth Children's Hospital
🇦🇺Nedlands, Western Australia, Australia
Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital
🇦🇺Nedlands, Western Australia, Australia
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
DD ordinace s.r.o.
🇨🇿Jindrichuv Hradec, Czechia
Ordinace praktického lékaře pro děti a dorost
🇨🇿Jindrichuv Hradec, Czechia
Zdravotnicke stredisko Dubina, verejna obchodni spolecnost
🇨🇿Pardubice, Czechia
MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
🇨🇿Praha 6, Czechia
Medicentrum 6 s.r.o.
🇨🇿Praha 6, Czechia
MUDr. Jitka Fabianova
🇨🇿Praha 3, Czechia
Kadrina Tervisekeskus OU
🇪🇪Kadrina, Estonia
Merelahe Family Doctors Centre
🇪🇪Tallinn, Estonia
OU Al Mare Perearstikeskus
🇪🇪Tallinn, Estonia
Merekivi Perearstid.
🇪🇪Tallinn, Estonia
Clinical Research Centre
🇪🇪Tartu, Estonia
Sinu Arst Health Center
🇪🇪Tallinn, Estonia
Helsinki South Vaccine Research Clinic
🇫🇮Helsinki, Finland
Espoo Vaccine Research Clinic
🇫🇮Espoo, Finland
Jarvenpaa Vaccine Research Clinic
🇫🇮Jarvenpaa, Finland
Helsinki East Vaccine Research Clinic
🇫🇮Helsinki, Finland
Kokkola Vaccine Research Clinic
🇫🇮Kokkola, Finland
Tampereen yliopisto Oulun Rokotetutkimusklinikka
🇫🇮Oulu, Finland
Seinäjoki Vaccine Research Clinic
🇫🇮Seinajoki, Finland
FVR, Oulun rokotetutkimusklinikka
🇫🇮Oulu, Finland
Pori Vaccine Research Clinic
🇫🇮Pori, Finland
Tampere Vaccine Research Center
🇫🇮Tampere, Finland
Turku Vaccine Research Clinic
🇫🇮Turku, Finland
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura
🇮🇹Milano, Milan, Italy
Azienda Ospedaliero Universitaria Meyer
🇮🇹Firenze, Italy
Azienda Ospedaliera Universitaria
🇮🇹Foggia, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Stichting Apotheek der Haarlemse Ziekenhuizen
🇳🇱Haarlem, Netherlands
Spaarne Gasthuis (Kennemer Gasthuis)
🇳🇱Hoofddorp, Netherlands
Akershus University Hospital
🇳🇴Lorenskog, Norway
Oslo University Hospital, Ulleval
🇳🇴Oslo, Norway
Stavanger University Hospital
🇳🇴Stavanger, Norway
Akershus University Hospital - Sykehusapoteket Ahus
🇳🇴Viken, Norway
IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz
🇵🇱Bydgoszcz, Poland
Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
🇵🇱Debica, Poland
Centrum Badan Klinicznych JCI
🇵🇱Krakow, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej
🇵🇱Krakow, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"
🇵🇱Leczna, Poland
GRAVITA. Diagnostyka i Leczenie nieplodnosci
🇵🇱Lodz, Poland
Rodzinne Centrum Medyczne LUBMED
🇵🇱Lubon, Poland
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
🇵🇱Poznan, Poland
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
🇵🇱Siemianowice Slaskie, Poland
Nasz Lekarz Przychodnie Medyczne Slawomir Jeka
🇵🇱Torun, Poland
Provita 001
🇵🇱Warszawa, Poland
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
🇵🇱Trzebnica, Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
🇵🇱Wroclaw, Poland
Szpital Bielanski im. ks. J. Popieluszki SPZOZ
🇵🇱Warszawa, Poland
Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
🇵🇱Wroclaw, Poland
Federal State Budget Institution of Healthcare Central clinical hospital of Russian
🇷🇺Moscow, Russian Federation
State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"
🇷🇺Perm, Russian Federation
State autonomous institution of healthcare of Sverdlovsk region
🇷🇺Ekaterinburg, Russian Federation
LLC PiterClinica
🇷🇺Saint Petersburg, Russian Federation
NASA DOKTORKA s.r.o.
🇸🇰Bratislava, Slovakia
Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.
🇸🇰Detva, Slovakia
MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast
🇸🇰Horne Srnie, Slovakia
Všeobecná ambulancia pre deti a dorast
🇸🇰Humenne, Slovakia
PEDAMB s.r.o.
🇸🇰Kosice, Slovakia
MUDr. Drusková s.r.o.
🇸🇰Liptovská Osada, Slovakia
PEDIAMED s.r.o.
🇸🇰Bratislava, Slovakia
University Hospital Antwerp
🇧🇪Edegem, Belgium
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Samostatna ordinace praktickeho lekare pro deti a dorost
🇨🇿Jindrichuv Hradec, Czechia