Healthy Subjects
Conditions
Brief summary
This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
Interventions
BIOLOGICAL13 valent pneumococcal conjugate vaccine
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects \>15months to \<18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4). Group 4 only: * Negative urine pregnancy test for female subjects who are menstruating.
Exclusion criteria
* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation. Group 4 only: * Previous vaccination with Prevnar or any other pneumococcal vaccine. * Pregnant or breastfeeding adolescent females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | 28 to 42 days after dose 1 for Group 3 and 4 | Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw. |
| Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2 | Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | 28 to 42 days after dose 1 for Group 3 | Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw. |
| Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457) | 28 to 42 days after dose 1 | Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | From the day of dose 1 (Day 1) to Day 7 after dose 1 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). |
| Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | From the day of dose 2 (Day 1) to Day 7 of dose 2 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). |
| Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | From the day of dose 1 (Day 1) to Day 7 of dose 1 | Systemic events (any fever \>=38 degrees \[deg\] Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. |
| Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | From the day of dose 2 (Day 1) to Day 7 of dose 2 | Systemic events (any fever \>=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days. |
Countries
United States
Participant flow
Pre-assignment details
Participants were stratified by age group. Group 1 included participants aged greater than (\>) 15 months to less than (\<) 2 years. Group 2 included participants aged greater than or equal to (\>=) 2 to \<5 years. Group 3 included participants aged \>=5 to \<10 years. Group 4 included participants aged \>=10 to \<18 years.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Group 1 (Cohort 1 and 2) 13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined) | 302 |
| 13vPnC Group 2 (Cohort 1 and 2) 13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined) | 300 |
| 13vPnC Group 3 13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC. | 299 |
| 13vPnC Group 4 13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine. | 299 |
| Total | 1,200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Failed to return | 1 | 0 | 1 | 1 | 5 | 2 |
| Overall Study | Lost to Follow-up | 2 | 4 | 7 | 1 | 6 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Parent/legal guardian request | 8 | 3 | 8 | 0 | 5 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 0 | 1 | 5 | 1 |
| Overall Study | Randomized, not treated | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 13vPnC Group 3 | 13vPnC Group 4 | Total | 13vPnC Group 2 (Cohort 1 and 2) | 13vPnC Group 1 (Cohort 1 and 2) |
|---|---|---|---|---|---|
| Age, Customized >10 years to <18 years | 0 Participants | 299 Participants | 299 Participants | 0 Participants | 0 Participants |
| Age, Customized >15 months to <2 years | 0 Participants | 0 Participants | 302 Participants | 0 Participants | 302 Participants |
| Age, Customized >=2 years to <5 years | 0 Participants | 0 Participants | 300 Participants | 300 Participants | 0 Participants |
| Age, Customized >=5 years to <10 years | 299 Participants | 0 Participants | 299 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 155 Participants | 136 Participants | 578 Participants | 139 Participants | 148 Participants |
| Sex: Female, Male Male | 144 Participants | 163 Participants | 622 Participants | 161 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 112 / 124 | 91 / 112 | 158 / 179 | 165 / 175 | 137 / 165 | 107 / 118 | 2 / 299 | 2 / 297 | 242 / 294 | 7 / 294 | 258 / 298 | 4 / 298 |
| serious Total, serious adverse events | 0 / 124 | 2 / 112 | 1 / 179 | 1 / 175 | 4 / 165 | 0 / 118 | 3 / 299 | 1 / 297 | 1 / 294 | 0 / 294 | 0 / 298 | 1 / 298 |
Outcome results
Primary
Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)
Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.
Time frame: 28 to 42 days after dose 1
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
Time frame: 28 to 42 days after dose 1 for Group 3
Population: EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Additional serotypes - serotype 6A | 21.51 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 4 | 8.45 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 6B | 53.56 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 9V | 9.51 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 14 | 29.36 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 18C | 8.23 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 19F | 17.58 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Common serotypes - serotype 23F | 11.26 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Additional serotypes - serotype 1 | 3.57 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Additional serotypes - serotype 3 | 2.38 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Additional serotypes - serotype 5 | 5.52 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Additional serotypes - serotype 7F | 6.24 mcg/mL |
| 13vPnC Group 1 (Cohort 1) | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 | Additional serotypes - serotype 19A | 17.18 mcg/mL |
Primary
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Time frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Population: Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 9V | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 1 | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 18C | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 3 | 94.5 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 6B | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 5 | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 19F | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 6A | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 14 | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 7F | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 23F | 99.1 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 19A | 100.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 4 | 98.2 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 19A | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 4 | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 6B | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 9V | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 14 | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 18C | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 19F | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Common serotypes - serotype 23F | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 1 | 98.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 3 | 92.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 5 | 98.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 6A | 100.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 | Additional serotypes - serotype 7F | 100.0 Percentage of participants |
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.
Time frame: 28 to 42 days after dose 1 for Group 3 and 4
Population: EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 9V | 4485 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 1 | 319 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 18C | 6263 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 3 | 114 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 6B | 14224 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 5 | 336 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 19F | 2280 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 6A | 9928 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 14 | 6894 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 7F | 6584 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 23F | 3808 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 19A | 1276 titer |
| 13vPnC Group 1 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 4 | 6912 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 19A | 1180 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 4 | 4629 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 6B | 14996 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 9V | 4733 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 14 | 4759 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 18C | 8815 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 19F | 1559 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Common serotypes - serotype 23F | 3245 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 1 | 187 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 3 | 202 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 5 | 491 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 6A | 7514 titer |
| 13vPnC Group 2 (Cohort 1) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 | Additional serotypes - serotype 7F | 10334 titer |
Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [1.24, 1.8]
Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.78, 1.15]
Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.8, 1.12]
Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [1.19, 1.76]
Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.59, 0.86]
Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [1.15, 1.86]
Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.97, 1.42]
Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [1.36, 2.13]
Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.48, 0.67]
Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.53, 0.89]
Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [1.05, 1.67]
Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.53, 0.76]
Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).95% CI: [0.91, 1.28]
Other Pre-specified
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).
Time frame: From the day of dose 1 (Day 1) to Day 7 after dose 1
Population: Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Mild (n=94,143,141,89,220,221) | 21.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Any (n=97,144,142,90,226,233) | 25.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Severe (n=90,138,131,88,212,213) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Moderate (n=94,142,135,89,218,221) | 12.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Mild (n=99,146,143,90,226,226) | 31.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Any (n=103,149,143,91,233,232) | 39.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Significant (n=92,141,133,92,221,242) | 7.6 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Any (n=108,155, 148,102,265,283) | 50.9 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Severe (n=90,138,131,88,211,214) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Moderate (n=94,141,135,89,219,226) | 9.6 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Significant (n=92,141,133,92,221,242) | 10.6 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Any (n=108,155, 148,102,265,283) | 61.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Any (n=97,144,142,90,226,233) | 22.2 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Mild (n=94,143,141,89,220,221) | 20.3 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Moderate (n=94,141,135,89,219,226) | 5.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Severe (n=90,138,131,88,211,214) | 0.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Any (n=103,149,143,91,233,232) | 34.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Mild (n=99,146,143,90,226,226) | 31.5 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Moderate (n=94,142,135,89,218,221) | 9.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Severe (n=90,138,131,88,212,213) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Mild (n=94,143,141,89,220,221) | 14.2 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Mild (n=99,146,143,90,226,226) | 16.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Any (n=108,155, 148,102,265,283) | 45.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Moderate (n=94,141,135,89,219,226) | 7.4 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Any (n=97,144,142,90,226,233) | 17.6 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Significant (n=92,141,133,92,221,242) | 5.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Severe (n=90,138,131,88,211,214) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Moderate (n=94,142,135,89,218,221) | 5.9 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Severe (n=90,138,131,88,212,213) | 0.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Any (n=103,149,143,91,233,232) | 18.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Any (n=103,149,143,91,233,232) | 36.3 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Mild (n=99,146,143,90,226,226) | 31.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Significant (n=92,141,133,92,221,242) | 13.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Severe (n=90,138,131,88,212,213) | 1.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Moderate (n=94,142,135,89,218,221) | 14.6 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Any (n=108,155, 148,102,265,283) | 62.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Severe (n=90,138,131,88,211,214) | 1.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Moderate (n=94,141,135,89,219,226) | 11.2 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Mild (n=94,143,141,89,220,221) | 13.5 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Any (n=97,144,142,90,226,233) | 20.0 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Any (n=103,149,143,91,233,232) | 42.9 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Mild (n=94,143,141,89,220,221) | 21.8 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Moderate (n=94,141,135,89,219,226) | 21.9 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Severe (n=90,138,131,88,211,214) | 3.3 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Any (n=108,155, 148,102,265,283) | 86.8 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Mild (n=99,146,143,90,226,226) | 27.9 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Severe (n=90,138,131,88,212,213) | 3.3 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Moderate (n=94,142,135,89,218,221) | 22.0 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Any (n=97,144,142,90,226,233) | 37.6 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Significant (n=92,141,133,92,221,242) | 19.5 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Severe (n=90,138,131,88,211,214) | 1.9 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Severe (n=90,138,131,88,212,213) | 1.9 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Significant (n=92,141,133,92,221,242) | 43.8 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Any (n=97,144,142,90,226,233) | 36.9 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Moderate (n=94,141,135,89,219,226) | 21.2 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Any (n=103,149,143,91,233,232) | 30.2 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Swelling Mild (n=94,143,141,89,220,221) | 22.6 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Mild (n=99,146,143,90,226,226) | 21.2 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Tenderness Any (n=108,155, 148,102,265,283) | 89.0 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 | Redness Moderate (n=94,142,135,89,218,221) | 14.0 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).
Time frame: From the day of dose 2 (Day 1) to Day 7 of dose 2
Population: Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Tenderness Any (n=87, 125) | 57.5 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Tenderness Significant (n=68, 101) | 8.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Any (n=73, 105) | 23.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Mild (n=72, 104) | 22.2 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Moderate (n=69, 102) | 2.9 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Severe (n=68, 98) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Any (n=76, 110) | 35.5 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Mild (n=74, 108) | 33.8 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Moderate (n=70, 100) | 7.1 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Severe (n=68, 98) | 0.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Mild (n=74, 108) | 18.5 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Tenderness Any (n=87, 125) | 55.2 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Severe (n=68, 98) | 0.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Tenderness Significant (n=68, 101) | 9.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Severe (n=68, 98) | 0.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Any (n=73, 105) | 17.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Any (n=76, 110) | 23.6 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Mild (n=72, 104) | 15.4 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Redness Moderate (n=70, 100) | 6.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 | Swelling Moderate (n=69, 102) | 7.8 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Systemic events (any fever \>=38 degrees \[deg\] Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary.
Time frame: From the day of dose 1 (Day 1) to Day 7 of dose 1
Population: Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Irritability (n=108,151,156,102,234,234) | 60.2 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >39 but <=40 degC(n=90,138,130,89,212,212) | 4.4 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased appetite (n=99,149,146,94,227,223) | 42.4 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Increased sleep (n=98,145,146,97,226,229) | 32.7 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased sleep (n=97,143,140,91,212,224) | 22.7 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >40 degC (n=90,138,130,88,210,212) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >=38 to <=39 degC(n=92,138,137,90,212,214) | 16.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Hives (urticaria) (n=90,139,131,88,213,214) | 1.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >39 but <=40 degC(n=90,138,130,89,212,212) | 0.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Hives (urticaria) (n=90,139,131,88,213,214) | 0.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased appetite (n=99,149,146,94,227,223) | 24.8 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased sleep (n=97,143,140,91,212,224) | 14.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Irritability (n=108,151,156,102,234,234) | 39.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Increased sleep (n=98,145,146,97,226,229) | 15.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >=38 to <=39 degC(n=92,138,137,90,212,214) | 5.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >40 degC (n=90,138,130,88,210,212) | 0.7 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased sleep (n=97,143,140,91,212,224) | 32.1 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Hives (urticaria) (n=90,139,131,88,213,214) | 1.5 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >39 but <=40 degC(n=90,138,130,89,212,212) | 4.6 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >40 degC (n=90,138,130,88,210,212) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >=38 to <=39 degC(n=92,138,137,90,212,214) | 17.5 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased appetite (n=99,149,146,94,227,223) | 39.7 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Irritability (n=108,151,156,102,234,234) | 72.4 Percentage of participants |
| 13vPnC Group 1 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Increased sleep (n=98,145,146,97,226,229) | 37.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >=38 to <=39 degC(n=92,138,137,90,212,214) | 14.4 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >40 degC (n=90,138,130,88,210,212) | 1.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Irritability (n=108,151,156,102,234,234) | 52.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >39 but <=40 degC(n=90,138,130,89,212,212) | 3.4 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased sleep (n=97,143,140,91,212,224) | 18.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Increased sleep (n=98,145,146,97,226,229) | 23.7 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Hives (urticaria) (n=90,139,131,88,213,214) | 4.5 Percentage of participants |
| 13vPnC Group 2 (Cohort 2) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased appetite (n=99,149,146,94,227,223) | 34.0 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Increased sleep (n=98,145,146,97,226,229) | 21.2 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >40 degC (n=90,138,130,88,210,212) | 0.5 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Hives (urticaria) (n=90,139,131,88,213,214) | 1.9 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased sleep (n=97,143,140,91,212,224) | 5.7 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased appetite (n=99,149,146,94,227,223) | 22.9 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Irritability (n=108,151,156,102,234,234) | 31.2 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >=38 to <=39 degC(n=92,138,137,90,212,214) | 4.2 Percentage of participants |
| 13vPnC Group 3 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >39 but <=40 degC(n=90,138,130,89,212,212) | 2.4 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Irritability (n=108,151,156,102,234,234) | 25.2 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >=38 to <=39 degC(n=92,138,137,90,212,214) | 5.1 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >39 but <=40 degC(n=90,138,130,89,212,212) | 0.5 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Fever >40 degC (n=90,138,130,88,210,212) | 0.5 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased appetite (n=99,149,146,94,227,223) | 22.9 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Hives (urticaria) (n=90,139,131,88,213,214) | 1.4 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Increased sleep (n=98,145,146,97,226,229) | 26.6 Percentage of participants |
| 13vPnC Group 4 | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 | Decreased sleep (n=97,143,140,91,212,224) | 18.8 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Systemic events (any fever \>=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.
Time frame: From the day of dose 2 (Day 1) to Day 7 of dose 2
Population: Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Fever >=38 but <=39 degC (n=70,101) | 14.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Fever >39 but <=40 degC (n=68, 100) | 4.4 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Fever >40 degC (n=68, 98) | 0.0 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Decreased appetite (n=77, 113) | 40.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Irritability (n=86, 126) | 65.1 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Increased sleep (n=75, 109) | 29.3 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Decreased sleep (n=77, 112) | 28.6 Percentage of participants |
| 13vPnC Group 1 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Hives (urticaria) (n=68, 98) | 2.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Hives (urticaria) (n=68, 98) | 0.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Fever >=38 but <=39 degC (n=70,101) | 11.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Irritability (n=86, 126) | 61.1 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Fever >39 but <=40 degC (n=68, 100) | 2.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Decreased sleep (n=77, 112) | 26.8 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Fever >40 degC (n=68, 98) | 1.0 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Increased sleep (n=75, 109) | 23.9 Percentage of participants |
| 13vPnC Group 2 (Cohort 1) | Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 | Decreased appetite (n=77, 113) | 34.5 Percentage of participants |