Healthy Subjects
Conditions
Keywords
vaccine, pneumococcal conjugate
Brief summary
Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.
Interventions
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
BIOLOGICALDTaP
0.5 mL per dose, 4 doses
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
* Male or female subjects between 3 to 6 months of age at the enrollment. * Available for the entire study period and whose parent/legal guardian can be reached by telephone. * Healthy infant as determined by medical history, physical examination, and judgement of the investigator.
Exclusion criteria
* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines. * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection. * History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis). * Infant who is a direct descendant (child, grandchild) of the study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 1 month after the infant series | Percentage of participants achieving 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) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference. |
| Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | 1 month after the infant series | Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA). |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 1 month after the infant series | Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are 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 the specified blood draw. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 1 month after the toddler dose | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference. |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 1 month after the infant series | Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference. |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | Antibody GMC as measured by mcg/mL for 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) are 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 the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference. |
| Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | 1 month after the toddler dose | Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA. |
| Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | 1 month after the infant series | GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | 1 month after the infant series | GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Within 7 days after Dose 3 of the infant series | 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). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Within 7 days after Dose 1 of infant series | Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Within 7 days after Dose 2 of infant series | Systemic events (any fever \>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Within 7 days after Dose 3 of infant series | Systemic events (any fever \>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Within 7 days after the toddler dose | Systemic events (any fever \>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Within 7 days after Dose 2 of the infant series | 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). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Within 7 days after Dose 1 of the infant series | 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). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Within 7 days after the toddler dose | 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). Participants may be represented in more than 1 category. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC + DTaP Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose. | 183 |
| 7vPnC + DTaP Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose. | 184 |
| DTaP (Catch-up 7vPnC) Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose. | 184 |
| Total | 551 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| After Infant Series | Adverse Event | 6 | 6 | 3 |
| After Infant Series | Lost to Follow-up | 1 | 0 | 0 |
| After Infant Series | Other | 1 | 2 | 2 |
| After Infant Series | Withdrawal by Subject | 10 | 8 | 4 |
| Infant Series | Adverse Event | 2 | 2 | 3 |
| Infant Series | Did not meet entrance criteria | 0 | 1 | 0 |
| Infant Series | Other | 1 | 0 | 0 |
| Infant Series | Randomized, not vaccinated | 0 | 1 | 1 |
| Infant Series | Withdrawal by Subject | 0 | 2 | 2 |
| Toddler Dose | Adverse Event | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | 13vPnC + DTaP | 7vPnC + DTaP | DTaP (Catch-up 7vPnC) | Total |
|---|---|---|---|---|
| Age, Continuous | 4.1 months STANDARD_DEVIATION 0.97 | 4.1 months STANDARD_DEVIATION 0.97 | 4.2 months STANDARD_DEVIATION 0.96 | 4.1 months STANDARD_DEVIATION 0.97 |
| Sex: Female, Male Female | 87 Participants | 91 Participants | 91 Participants | 269 Participants |
| Sex: Female, Male Male | 96 Participants | 93 Participants | 93 Participants | 282 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 147 / 183 | 160 / 183 | 155 / 183 | 20 / 183 | 27 / 183 | 147 / 183 | 104 / 162 | 99 / 162 | 112 / 169 | 105 / 169 |
| serious Total, serious adverse events | 5 / 183 | 8 / 183 | 10 / 183 | 13 / 183 | 15 / 183 | 10 / 183 | 0 / 162 | 4 / 162 | 2 / 169 | 2 / 169 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are 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 the specified blood draw.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 23F | 3.64 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 6B | 4.50 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 9V | 5.04 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 14 | 13.86 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 18C | 5.30 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 19F | 7.37 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 4 | 9.40 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 18C | 7.26 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 4 | 11.54 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 14 | 16.79 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 6B | 5.71 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 19F | 8.38 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 9V | 6.80 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series | 23F | 4.53 mcg/mL |
Comparison: Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.71, 0.94]
Comparison: Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.64, 0.97]
Comparison: Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.64, 0.86]
Comparison: Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.7, 0.98]
Comparison: Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.63, 0.85]
Comparison: Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.72, 1.08]
Comparison: Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.66, 0.98]
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Diphtheria | 99.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Tetanus | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Pertussis toxoid (PT) | 99.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Diphtheria | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Pertussis toxoid (PT) | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Tetanus | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Tetanus | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Pertussis toxoid (PT) | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series | Diphtheria | 100.0 percentage of participants |
Comparison: Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [-3.1, 1.6]
Comparison: Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [-2.1, 2.2]
Comparison: Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [-3.1, 1.6]
Comparison: Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.95% CI: [-3.1, 1.6]
Primary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving 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) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 4 | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 6B | 97.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 9V | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 14 | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 3 | 99.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 5 | 99.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 6A | 98.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 7F | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 19A | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 18C | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 19F | 98.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 23F | 97.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 1 | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 19F | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 4 | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 7F | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 6B | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 1 | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 9V | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 19A | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 14 | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 23F | 98.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 3 | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 18C | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 5 | 96.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series | 6A | 96.6 percentage of participants |
Comparison: Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).95% CI: [-2.2, 2.1]
Comparison: Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-5.2, 1.1]
Comparison: Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.1, 2.1]
Comparison: Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.1, 2.1]
Comparison: Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.1, 2.1]
Comparison: Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-1.1, 6.3]
Comparison: Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-4.2, 2.9]
Comparison: Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [0.9, 7.3]
Comparison: Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-0.2, 6.7]
Comparison: Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-0.2, 6.7]
Comparison: Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-1.9, 5.8]
Comparison: Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [0.9, 7.3]
Comparison: Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1, 7.3]
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | Pertussis toxoid (PT) | 66.12 EU/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 62.30 EU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | Pertussis toxoid (PT) | 57.26 EU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 53.86 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | Pertussis toxoid (PT) | 67.64 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 67.48 EU/mL |
Comparison: GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [0.87, 1.1]
Comparison: GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.95% CI: [0.81, 1.05]
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Time frame: 1 month after the toddler dose
Population: Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | Pertussis toxoid (PT) | 144.46 EU/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | Filamentous hemagglutinin (FHA) | 143.68 EU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | Pertussis toxoid (PT) | 135.65 EU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | Filamentous hemagglutinin (FHA) | 141.19 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | Pertussis toxoid (PT) | 150.21 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | Filamentous hemagglutinin (FHA) | 180.31 EU/mL |
Comparison: GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [0.84, 1.11]
Comparison: GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.95% CI: [0.7, 0.91]
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | Diphtheria | 1.03 IU/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | Tetanus | 1.50 IU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | Diphtheria | 1.10 IU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | Tetanus | 1.37 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | Diphtheria | 0.93 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series | Tetanus | 1.66 IU/mL |
Comparison: GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [0.97, 1.24]
Comparison: GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [0.77, 1.06]
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Time frame: 1 month after the toddler dose
Population: Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Diphtheria | 2.65 IU/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Tetanus | 2.90 IU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Diphtheria | 3.18 IU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Tetanus | 2.60 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Diphtheria | 2.63 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Tetanus | 2.89 IU/mL |
Comparison: GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [0.88, 1.15]
Comparison: GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [0.85, 1.19]
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody GMC as measured by mcg/mL for 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) are 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 the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Time frame: 1 month after the toddler dose
Population: Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had \>=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B | 17.05 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 | 13.96 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C | 8.10 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 | 2.48 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 | 15.34 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 | 11.10 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F | 16.73 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A | 15.17 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 | 19.70 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F | 10.90 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F | 8.64 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A | 16.02 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V | 7.00 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A | 8.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V | 8.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 | 16.35 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B | 13.91 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 | 20.69 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C | 9.88 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F | 9.55 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F | 10.00 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 | 8.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 | 8.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 | 8.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A | 8.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F | 8.64 mcg/mL |
Comparison: Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.77, 1.15]
Comparison: Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.98, 1.53]
Comparison: Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.67, 0.98]
Comparison: Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.81, 1.12]
Comparison: Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.67, 1.01]
Comparison: Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [1.39, 2.21]
Comparison: Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.95% CI: [0.7, 1.07]
Comparison: Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.31, 1.99]
Comparison: Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [0.24, 0.35]
Comparison: Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.07, 1.54]
Comparison: Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.46, 2.12]
Comparison: Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.04, 1.52]
Comparison: Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.54, 2.24]
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Time frame: 1 month after the infant series
Population: Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 19A | 8.56 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 1 | 8.14 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 6A | 4.71 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 3 | 4.90 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 7F | 8.26 mcg/mL |
| 13vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 5 | 4.64 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 19A | 4.53 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 5 | 4.53 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 7F | 4.53 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 1 | 4.53 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 6A | 4.53 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series | 3 | 4.53 mcg/mL |
Comparison: Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.5, 2.15]
Comparison: Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [0.92, 1.28]
Comparison: Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [0.86, 1.22]
Comparison: Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [0.87, 1.25]
Comparison: Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.54, 2.16]
Comparison: Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [1.59, 2.25]
Secondary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
Time frame: 1 month after the toddler dose
Population: Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Diphtheria | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Tetanus | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Pertussis toxoid (PT) | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Filamentous hemagglutinin (FHA) | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Filamentous hemagglutinin (FHA) | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Diphtheria | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Pertussis toxoid (PT) | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Tetanus | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Filamentous hemagglutinin (FHA) | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Tetanus | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Pertussis toxoid (PT) | 100.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose | Diphtheria | 100.0 percentage of participants |
Comparison: Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [-2.4, 2.3]
Comparison: Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [-2.4, 2.3]
Comparison: Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.95% CI: [-2.4, 2.3]
Comparison: Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.95% CI: [-2.4, 2.3]
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
Time frame: 1 month after the toddler dose
Population: Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had \>=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 23F | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 7F | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 3 | 99.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 4 | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 19F | 98.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 9V | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 5 | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 14 | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 1 | 99.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 18C | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 6A | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 19A | 100.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 6B | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 19A | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 6B | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 19F | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 23F | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 1 | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 3 | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 5 | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 6A | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 7F | 99.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 4 | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 9V | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 14 | 100.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose | 18C | 100.0 percentage of participants |
Comparison: Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.4, 2.4]
Comparison: Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.4, 2.4]
Comparison: Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.4, 2.4]
Comparison: Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.4, 2.4]
Comparison: Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.4, 2.4]
Comparison: Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-3.9, 2.4]
Comparison: Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.95% CI: [-2.4, 2.4]
Comparison: Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-2.9, 3]
Comparison: Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-2.9, 3]
Comparison: Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-1.7, 3.6]
Comparison: Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-1.7, 3.6]
Comparison: Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-1.7, 3.6]
Comparison: Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.95% CI: [-1.7, 3.6]
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
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). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 1 of the infant series
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- severe (n=161, 162, 162) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Any (n=168, 168, 164) | 41.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Tenderness- Significant (n=161, 162, 162) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Moderate (n=162, 165, 162) | 12.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Mild (n= 168, 168, 164) | 38.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Any (n=171, 172, 165) | 58.5 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Moderate (n=164, 166, 162) | 18.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Mild (n=170, 172, 165) | 48.2 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Tenderness- Any (n=163, 164, 162) | 13.5 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Severe (n=161, 162, 162) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Any local reaction (n=175, 174, 165) | 68.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Mild (n= 168, 168, 164) | 31.5 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Any (n=171, 172, 165) | 55.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Mild (n=170, 172, 165) | 51.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Moderate (n=164, 166, 162) | 18.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Severe (n=161, 162, 162) | 0.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Any (n=168, 168, 164) | 35.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Moderate (n=162, 165, 162) | 12.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- severe (n=161, 162, 162) | 0.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Tenderness- Any (n=163, 164, 162) | 6.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Tenderness- Significant (n=161, 162, 162) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Any local reaction (n=175, 174, 165) | 60.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Tenderness- Significant (n=161, 162, 162) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- severe (n=161, 162, 162) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Moderate (n=164, 166, 162) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Any (n=171, 172, 165) | 10.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Tenderness- Any (n=163, 164, 162) | 1.2 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Mild (n=170, 172, 165) | 10.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Mild (n= 168, 168, 164) | 4.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Any (n=168, 168, 164) | 4.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Any local reaction (n=175, 174, 165) | 12.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Swelling- Moderate (n=162, 165, 162) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Redness- Severe (n=161, 162, 162) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
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). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 2 of the infant series
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- severe (n= 157, 154, 154) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Any (n= 160, 171, 162) | 48.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Tenderness- Significant (n= 157, 154, 154) | 0.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Moderate (n= 157, 157, 155) | 19.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Mild (n= 160, 170, 162) | 44.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Any (n= 166, 168, 161) | 62.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Moderate (n= 157, 159, 156) | 26.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Mild (n= 166, 167, 161) | 56.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Tenderness- Any (n= 159, 154, 155) | 14.5 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Severe (n= 157, 154, 154) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Any local reaction (n=167, 173, 164) | 71.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Mild (n= 160, 170, 162) | 48.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Any (n= 166, 168, 161) | 61.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Mild (n= 166, 167, 161) | 56.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Moderate (n= 157, 159, 156) | 27.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Severe (n= 157, 154, 154) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Any (n= 160, 171, 162) | 50.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Moderate (n= 157, 157, 155) | 17.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- severe (n= 157, 154, 154) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Tenderness- Any (n= 159, 154, 155) | 4.5 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Tenderness- Significant (n= 157, 154, 154) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Any local reaction (n=167, 173, 164) | 67.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Tenderness- Significant (n= 157, 154, 154) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- severe (n= 157, 154, 154) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Moderate (n= 157, 159, 156) | 8.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Any (n= 166, 168, 161) | 36.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Tenderness- Any (n= 159, 154, 155) | 1.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Mild (n= 166, 167, 161) | 34.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Mild (n= 160, 170, 162) | 22.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Any (n= 160, 171, 162) | 24.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Any local reaction (n=167, 173, 164) | 40.2 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Swelling- Moderate (n= 157, 157, 155) | 5.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Redness- Severe (n= 157, 154, 154) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
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). Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 3 of the infant series
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- severe (n= 149, 152, 152) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Any (n= 164, 157, 159) | 43.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness- Significant (n= 149, 152, 152) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Moderate (n= 150, 154, 153) | 10.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Mild (n= 164, 156, 159) | 42.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Any (n= 168, 162, 156) | 53.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Moderate (n= 152, 154, 153) | 17.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Mild (n= 167, 160, 156) | 47.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness- Any (n= 153, 155, 153) | 7.8 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Severe (n= 149, 152, 152) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Any local reaction (n=171, 163, 160) | 62.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Mild (n= 164, 156, 159) | 34.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Any (n= 168, 162, 156) | 51.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Mild (n= 167, 160, 156) | 43.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Moderate (n= 152, 154, 153) | 22.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Severe (n= 149, 152, 152) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Any (n= 164, 157, 159) | 37.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Moderate (n= 150, 154, 153) | 14.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- severe (n= 149, 152, 152) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness- Any (n= 153, 155, 153) | 7.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness- Significant (n= 149, 152, 152) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Any local reaction (n=171, 163, 160) | 55.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness- Significant (n= 149, 152, 152) | 0.7 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- severe (n= 149, 152, 152) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Moderate (n= 152, 154, 153) | 2.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Any (n= 168, 162, 156) | 23.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness- Any (n= 153, 155, 153) | 2.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Mild (n= 167, 160, 156) | 21.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Mild (n= 164, 156, 159) | 20.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Any (n= 164, 157, 159) | 21.4 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Any local reaction (n=171, 163, 160) | 28.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Swelling- Moderate (n= 150, 154, 153) | 2.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Redness- Severe (n= 149, 152, 152) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
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). Participants may be represented in more than 1 category.
Time frame: Within 7 days after the toddler dose
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Severe (n= 140, 136, 141) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Mild (n= 148, 151, 148) | 50.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- severe (n= 140, 136, 141) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Moderate (n= 143, 138, 146) | 16.8 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Mild (n= 147, 143, 146) | 42.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Any (n= 149, 144, 148) | 49.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Any (n= 148, 152, 149) | 62.2 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness- Significant (n= 140, 136, 141) | 0.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Moderate (n= 141, 139, 145) | 27.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Any local reaction (n=153, 152, 151) | 68.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness- Any (n= 142, 140 ,142) | 14.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Mild (n= 147, 143, 146) | 42.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Any (n= 149, 144, 148) | 45.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Any (n= 148, 152, 149) | 57.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Mild (n= 148, 151, 148) | 47.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Moderate (n= 141, 139, 145) | 27.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Severe (n= 140, 136, 141) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Moderate (n= 143, 138, 146) | 18.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- severe (n= 140, 136, 141) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness- Any (n= 142, 140 ,142) | 10.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness- Significant (n= 140, 136, 141) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Any local reaction (n=153, 152, 151) | 61.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness- Significant (n= 140, 136, 141) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- severe (n= 140, 136, 141) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Moderate (n= 141, 139, 145) | 13.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Any (n= 148, 152, 149) | 34.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness- Any (n= 142, 140 ,142) | 5.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Mild (n= 148, 151, 148) | 28.4 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Mild (n= 147, 143, 146) | 22.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Any (n= 149, 144, 148) | 26.4 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Any local reaction (n=153, 152, 151) | 37.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Swelling- Moderate (n= 143, 138, 146) | 13.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Redness- Severe (n= 140, 136, 141) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 1 of infant series
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >=37.5,=<39 degrees C (n=168, 168, 165) | 36.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >39,=<40 degrees C (n=161, 163, 162) | 0.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >40 degrees C (n=161, 162, 162) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Decreased appetite (n=163, 163, 165) | 12.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Irritability (n=165, 164, 164) | 18.8 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Increased sleep (n=170, 165, 165) | 28.8 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Decreased sleep (n=164, 169, 167) | 18.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Hives- urticaria (n=161, 162, 162) | 3.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Use of antipyretic medication (n= 161, 162, 162) | 3.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Any systemic event (n=177, 174, 172) | 61.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Use of antipyretic medication (n= 161, 162, 162) | 2.5 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >=37.5,=<39 degrees C (n=168, 168, 165) | 33.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Increased sleep (n=170, 165, 165) | 26.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Irritability (n=165, 164, 164) | 16.5 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >39,=<40 degrees C (n=161, 163, 162) | 1.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Any systemic event (n=177, 174, 172) | 59.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Hives- urticaria (n=161, 162, 162) | 1.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >40 degrees C (n=161, 162, 162) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Decreased sleep (n=164, 169, 167) | 21.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Decreased appetite (n=163, 163, 165) | 9.2 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Hives- urticaria (n=161, 162, 162) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Decreased appetite (n=163, 163, 165) | 7.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Irritability (n=165, 164, 164) | 12.2 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Increased sleep (n=170, 165, 165) | 21.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Use of antipyretic medication (n= 161, 162, 162) | 0.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Decreased sleep (n=164, 169, 167) | 13.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >=37.5,=<39 degrees C (n=168, 168, 165) | 21.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Any systemic event (n=177, 174, 172) | 43.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >39,=<40 degrees C (n=161, 163, 162) | 0.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Fever >40 degrees C (n=161, 162, 162) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Systemic events (any fever \>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 2 of infant series
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >=37.5, =<39 degrees C (n=166, 161, 155) | 36.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >39, =<40 degrees C (n=158, 155, 154) | 1.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >40 degrees C (n=157, 154, 154) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Decreased appetite (n=158, 159, 155) | 11.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Irritability (n=162, 155, 156) | 17.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Increased sleep (n=163, 158, 163) | 22.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Decreased sleep (n=161, 157, 157) | 18.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Hives- urticaria (n=157, 154, 154) | 2.5 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Use of antipyretic medication (n=160, 155, 154) | 3.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Any systemic event (n=170, 169, 166) | 61.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Use of antipyretic medication (n=160, 155, 154) | 4.5 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >=37.5, =<39 degrees C (n=166, 161, 155) | 36.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Increased sleep (n=163, 158, 163) | 22.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Irritability (n=162, 155, 156) | 18.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >39, =<40 degrees C (n=158, 155, 154) | 3.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Any systemic event (n=170, 169, 166) | 57.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Hives- urticaria (n=157, 154, 154) | 1.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >40 degrees C (n=157, 154, 154) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Decreased sleep (n=161, 157, 157) | 12.1 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Decreased appetite (n=158, 159, 155) | 14.5 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Hives- urticaria (n=157, 154, 154) | 1.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Decreased appetite (n=158, 159, 155) | 7.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Irritability (n=162, 155, 156) | 10.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Increased sleep (n=163, 158, 163) | 22.7 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Use of antipyretic medication (n=160, 155, 154) | 1.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Decreased sleep (n=161, 157, 157) | 12.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >=37.5, =<39 degrees C (n=166, 161, 155) | 21.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Any systemic event (n=170, 169, 166) | 44.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >39, =<40 degrees C (n=158, 155, 154) | 0.6 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >40 degrees C (n=157, 154, 154) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Systemic events (any fever \>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after Dose 3 of infant series
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >=37.5, =<39 degrees C (n=162, 161, 157) | 34.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >39, =<40 degrees C (n=150, 152, 153) | 3.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >40 degrees C (n=149, 152, 152) | 0.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Decreased appetite (n=152, 155, 154) | 9.9 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Irritability (n=154, 156, 154) | 17.5 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Increased sleep (n=151, 157, 154) | 20.5 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Decreased sleep (n= 154, 156, 153) | 18.2 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Hives- urticaria (n= 149, 152, 152) | 1.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Use of antipyretic medication (n=150, 153, 154) | 2.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Any systemic event (n=168, 164, 159) | 57.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Use of antipyretic medication (n=150, 153, 154) | 3.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >=37.5, =<39 degrees C (n=162, 161, 157) | 30.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Increased sleep (n=151, 157, 154) | 20.4 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Irritability (n=154, 156, 154) | 14.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >39, =<40 degrees C (n=150, 152, 153) | 2.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Any systemic event (n=168, 164, 159) | 50.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Hives- urticaria (n= 149, 152, 152) | 0.0 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >40 degrees C (n=149, 152, 152) | 0.7 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Decreased sleep (n= 154, 156, 153) | 12.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Decreased appetite (n=152, 155, 154) | 9.7 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Hives- urticaria (n= 149, 152, 152) | 1.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Decreased appetite (n=152, 155, 154) | 5.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Irritability (n=154, 156, 154) | 11.7 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Increased sleep (n=151, 157, 154) | 14.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Use of antipyretic medication (n=150, 153, 154) | 4.5 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Decreased sleep (n= 154, 156, 153) | 9.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >=37.5, =<39 degrees C (n=162, 161, 157) | 24.2 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Any systemic event (n=168, 164, 159) | 40.9 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >39, =<40 degrees C (n=150, 152, 153) | 3.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >40 degrees C (n=149, 152, 152) | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Systemic events (any fever \>= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after the toddler dose
Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased sleep (n=142, 137, 141) | 12.7 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased appetite (n=143, 141, 143) | 19.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Use of antipyretic medication (n=141, 138, 142) | 7.1 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Increased sleep (n=145, 142, 143) | 18.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Irritability (n=143, 141, 144) | 18.2 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >39, =<40 degrees C (n=141, 136, 141) | 4.3 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >=37.5, =<39 degrees C (n=145, 146, 146) | 49.0 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Hives- urticaria (n=140, 136, 141) | 3.6 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >40 degrees C (n=139, 137, 141) | 1.4 percentage of participants |
| 13vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Any systemic event (n=148, 152, 149) | 62.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Irritability (n=143, 141, 144) | 21.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >=37.5, =<39 degrees C (n=145, 146, 146) | 49.3 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >39, =<40 degrees C (n=141, 136, 141) | 8.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >40 degrees C (n=139, 137, 141) | 2.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased appetite (n=143, 141, 143) | 19.9 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Any systemic event (n=148, 152, 149) | 63.8 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Increased sleep (n=145, 142, 143) | 17.6 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased sleep (n=142, 137, 141) | 9.5 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Hives- urticaria (n=140, 136, 141) | 2.2 percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Use of antipyretic medication (n=141, 138, 142) | 9.4 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >40 degrees C (n=139, 137, 141) | 0.0 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Any systemic event (n=148, 152, 149) | 50.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased sleep (n=142, 137, 141) | 11.3 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >39, =<40 degrees C (n=141, 136, 141) | 3.5 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Use of antipyretic medication (n=141, 138, 142) | 4.2 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Hives- urticaria (n=140, 136, 141) | 2.1 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Irritability (n=143, 141, 144) | 16.7 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased appetite (n=143, 141, 143) | 9.8 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >=37.5, =<39 degrees C (n=145, 146, 146) | 31.5 percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Increased sleep (n=145, 142, 143) | 16.1 percentage of participants |