Healthy Subjects
Conditions
Keywords
vaccine, pneumococcal conjugate
Brief summary
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.
Interventions
BIOLOGICAL7-pneumococcal conjugate vaccine (7vPnC)
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
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment. * Available for entire study period and whose parent/legal guardian can be reached by telephone. * Healthy infant as determined by medical history, physical examination, and judgment 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). * Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. 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) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series | 1 month after the infant series | GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. |
| 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% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants. |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 month after the infant series | Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | Pre-toddler dose, 1 month after the toddler dose | Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. |
| 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 | Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 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) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 1 month after the catch-up dose 3 | Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 | 1 month after the catch-up dose 3 | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants. |
| Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | GMCs were 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 | GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. |
| 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 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants. |
| 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 GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Within 7 days after Catch-up Dose 3 | 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 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. |
| 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. |
| 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Within 7 days after Catch-up Dose 1 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Within 7 days after Catch-up Dose 2 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. |
| Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Within 7 days after Catch-up Dose 3 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. |
| 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 the 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 the 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 3 (5 to 10 Months of Age) | Within 7 days after Dose 3 of the 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: Toddler Dose (12 to 15 Months of Age) | Within 7 days after the toddler dose | 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: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Within 7 days after Catch-up Dose 1 | 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: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Within 7 days after Catch-up Dose 2 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 7vPnC + DTaP Participants at 3 to 6 months of age received a single 0.5 milliliter (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 diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose. | 161 |
| 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. | 160 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 5 | 2 |
| After Infant Series | Other | 2 | 1 |
| After Infant Series | Withdrawal by Subject | 4 | 1 |
| After Toddler Dose | Adverse Event | 0 | 1 |
| Infant Series | Other | 22 | 0 |
| Infant Series | Randomized, Not Vaccinated | 2 | 2 |
| Infant Series | Withdrawal by Subject | 4 | 5 |
| Toddler Dose | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | 7vPnC + DTaP | DTaP (Catch-up 7vPnC) | Total |
|---|---|---|---|
| Age Continuous | 3.8 months STANDARD_DEVIATION 0.91 | 3.9 months STANDARD_DEVIATION 0.94 | 3.9 months STANDARD_DEVIATION 0.93 |
| Sex: Female, Male Female | 80 Participants | 82 Participants | 162 Participants |
| Sex: Female, Male Male | 81 Participants | 78 Participants | 159 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 123 / 159 | 126 / 158 | 20 / 159 | 129 / 158 | 72 / 122 | 96 / 149 | 85 / 149 |
| serious Total, serious adverse events | 3 / 159 | 7 / 158 | 10 / 159 | 7 / 158 | 0 / 122 | 4 / 149 | 1 / 149 |
Outcome results
Primary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
GMCs were 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 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series | Pertussis toxoid (PT) | 76.79 EU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 72.89 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series | Pertussis toxoid (PT) | 83.56 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series | Filamentous hemagglutinin (FHA) | 77.85 EU/mL |
Primary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (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, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series | Diphtheria | 1.38 IU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series | Tetanus | 1.91 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series | Tetanus | 2.05 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series | Diphtheria | 0.99 IU/mL |
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% 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, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 | 11.82 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B | 4.23 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V | 5.96 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C | 5.48 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F | 8.85 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F | 4.17 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 | 16.61 mcg/mL |
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. 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, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 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 |
| 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) | 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 Infant Series | 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 Infant Series | Diphtheria | 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 |
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% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
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, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 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 | 6B | 99.2 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 | 23F | 98.5 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 | 99.2 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 | 99.2 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 | 97.7 Percentage of participants |
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
GMCs were 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 set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | PT | 106.54 EU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | FHA | 120.99 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | PT | 130.62 EU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose | FHA | 145.38 EU/mL |
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
GMCs were 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 set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Diphtheria | 2.56 IU/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Tetanus | 2.53 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Diphtheria | 2.14 IU/mL |
| DTaP (Catch-up 7vPnC) | Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose | Tetanus | 3.04 IU/mL |
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Time frame: 1 month after the catch-up dose 3
Population: Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 4 | 6.63 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 6B | 4.30 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 9V | 3.48 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 14 | 11.55 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 18C | 3.10 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 19F | 5.16 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 | 23F | 4.41 mcg/mL |
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
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 protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 | 12.15 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B | 10.66 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V | 6.43 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 | 15.83 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C | 6.53 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F | 9.70 mcg/mL |
| 7vPnC + DTaP | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F | 10.17 mcg/mL |
Secondary
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time frame: Pre-toddler dose, 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 protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 4 | 6.74 Fold Rise |
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 6B | 5.89 Fold Rise |
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 9V | 4.34 Fold Rise |
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 19F | 6.37 Fold Rise |
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 23F | 8.10 Fold Rise |
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 14 | 3.63 Fold Rise |
| 7vPnC + DTaP | Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose | 18C | 6.90 Fold Rise |
Secondary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 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 set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 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 | Tetanus | 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 | 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 | 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 | Diphtheria | 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 | Tetanus | 100.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the catch-up dose 3
Population: Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 | 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 Catch-up Dose 3 | 6B | 99.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 | 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 Catch-up Dose 3 | 18C | 99.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 | 19F | 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 Catch-up Dose 3 | 23F | 99.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 | 14 | 100.0 Percentage of participants |
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 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
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 protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 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 | 99.2 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 | 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 | 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 | 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 | 99.2 Percentage of participants |
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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Induration-Any (n= 149, 153) | 40.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Induration-Mild (n= 149, 153) | 38.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Induration-Moderate (n= 148, 151) | 10.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Induration-Severe (n= 148, 151) | 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) | Tenderness-Any (n= 148, 151) | 12.2 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= 148, 151) | 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= 152, 154) | 66.4 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Erythema-Any (n= 152, 152) | 57.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Erythema-Mild (n= 152, 151) | 52.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Erythema-Moderate (n= 148, 152) | 14.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) | Erythema-Severe (n= 148, 151) | 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) | Erythema-Any (n= 152, 152) | 14.5 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) | Erythema-Severe (n= 148, 151) | 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) | Induration-Any (n= 149, 153) | 7.8 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= 148, 151) | 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) | Induration-Mild (n= 149, 153) | 7.8 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) | Erythema-Moderate (n= 148, 152) | 2.0 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) | Induration-Moderate (n= 148, 151) | 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) | Any local reaction (n= 152, 154) | 15.6 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) | Induration-Severe (n= 148, 151) | 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) | Erythema-Mild (n= 152, 151) | 12.6 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= 148, 151) | 0.7 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Erythema-Any (n= 142, 150) | 64.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Induration-Any (n= 137, 150) | 51.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Induration-Mild (n= 137, 150) | 49.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Induration-Moderate (n= 134, 148) | 23.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Induration-Severe (n= 133, 147) | 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= 133, 147) | 7.5 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= 143, 151) | 69.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Erythema-Mild (n= 142, 150) | 58.5 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Erythema-Moderate (n= 134, 147) | 32.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) | Erythema-Severe (n= 133, 147) | 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-Significant (n= 133, 147) | 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) | Tenderness-Any (n= 133, 147) | 4.1 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) | Erythema-Severe (n= 133, 147) | 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) | Tenderness-Significant (n= 133, 147) | 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) | Induration-Any (n= 137, 150) | 30.0 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) | Erythema-Mild (n= 142, 150) | 33.3 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) | Induration-Mild (n= 137, 150) | 28.7 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= 143, 151) | 45.0 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) | Induration-Moderate (n= 134, 148) | 6.8 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) | Erythema-Any (n= 142, 150) | 39.3 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) | Induration-Severe (n= 133, 147) | 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) | Erythema-Moderate (n= 134, 147) | 6.8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Tenderness-Any (n= 119, 138) | 5.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Erythema-Moderate (n= 120, 139) | 20.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Erythema-Severe (n= 118, 138) | 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) | Induration-Any (n= 124, 144) | 44.4 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Induration-Mild (n= 124, 144) | 42.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Induration-Moderate (n= 119, 139) | 11.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Induration-Severe (n= 118, 138) | 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-Significant (n= 118, 138) | 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= 126, 145) | 61.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Erythema-Mild (n= 123, 143) | 46.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) | Erythema-Any (n= 123, 144) | 52.8 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) | Erythema-Any (n= 123, 144) | 30.6 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) | Erythema-Mild (n= 123, 143) | 28.0 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) | Tenderness-Any (n= 119, 138) | 3.6 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) | Erythema-Moderate (n= 120, 139) | 5.8 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) | Induration-Severe (n= 118, 138) | 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) | Erythema-Severe (n= 118, 138) | 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) | Tenderness-Significant (n= 118, 138) | 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) | Induration-Any (n= 124, 144) | 19.4 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) | Induration-Moderate (n= 119, 139) | 2.2 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) | Induration-Mild (n= 124, 144) | 19.4 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= 126, 145) | 33.1 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Time frame: Within 7 days after Catch-up Dose 1
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Erythema-Any (n= 139) | 51.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Erythema-Mild (n= 139) | 45.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Erythema-Moderate (n= 136) | 10.3 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Erythema-Severe (n= 135) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Induration-Any (n= 138) | 34.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Induration-Mild (n= 138) | 32.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Induration-Moderate (n= 135) | 8.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Induration-Severe (n= 135) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Tenderness-Any (n= 136) | 8.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Tenderness-Significant (n= 135) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Any local reaction (n= 141) | 54.6 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Time frame: Within 7 days after Catch-up Dose 2
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Erythema-Any (n= 144) | 50.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Erythema-Mild (n= 144) | 45.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Erythema-Moderate (n= 140) | 13.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Erythema-Severe (n= 138) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Induration-Any (n= 144) | 32.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Induration-Mild (n= 143) | 30.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Induration-Moderate (n= 140) | 15.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Induration-Severe (n= 138) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Tenderness-Any (n= 139) | 5.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Tenderness-Significant (n= 138) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Any local reaction (n= 145) | 55.2 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Time frame: Within 7 days after Catch-up Dose 3
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Erythema-Any (n= 134) | 32.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Erythema-Mild (n= 133) | 27.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Erythema-Moderate (n= 131) | 9.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Erythema-Severe (n= 130) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Induration-Any (n= 134) | 27.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Induration-Mild (n= 133) | 24.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Induration-Moderate (n= 131) | 9.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Induration-Severe (n= 130) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Tenderness-Any (n= 132) | 6.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Any local reaction (n= 137) | 40.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) | Tenderness-Significant (n= 130) | 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Severe (n= 98, 133) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Moderate (n= 99, 133) | 16.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Moderate (n= 102, 134) | 23.5 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Severe (n= 98, 133) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Any (n= 108, 137) | 42.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness-Any (n= 99, 136) | 11.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Tenderness-Significant (n= 98, 133) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Mild (n= 106, 137) | 48.1 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= 110, 138) | 56.4 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Mild (n= 108, 137) | 40.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Any (n= 108, 137) | 51.9 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= 99, 136) | 4.4 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Any (n= 108, 137) | 32.1 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Mild (n= 106, 137) | 28.5 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Moderate (n= 102, 134) | 7.5 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Erythema-Severe (n= 98, 133) | 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) | Induration-Any (n= 108, 137) | 23.4 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Mild (n= 108, 137) | 19.7 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Moderate (n= 99, 133) | 6.8 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) | Induration-Severe (n= 98, 133) | 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) | Tenderness-Significant (n= 98, 133) | 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) | Any local reaction (n= 110, 138) | 39.1 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 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 systemic event. '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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Irritability(n=151,151) | 15.2 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=148,151) | 1.4 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=148,151) | 8.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) | Antipyretic medication to treat symptom(n=148,151) | 1.4 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=150,153) | 32.0 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=148,151) | 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) | Fever >39 but =<40.0 degrees C(n=148,151) | 2.0 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=151,151) | 16.6 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=154,153) | 57.8 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 but =<39 degrees C(n=149,152) | 18.8 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=154,153) | 48.4 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 but =<39 degrees C(n=149,152) | 15.8 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) | Decreased appetite(n=148,151) | 7.9 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=151,151) | 9.3 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) | Increased sleep(n=150,153) | 25.5 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=151,151) | 15.2 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=148,151) | 0.7 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 but =<40.0 degrees C(n=148,151) | 2.0 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 >40 degrees C(n=148,151) | 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) | Antipyretic medication to treat symptom(n=148,151) | 1.3 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 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 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 systemic event. '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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Fever >39 but =<40.0 degrees C(n=135,147) | 2.2 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=133,147) | 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) | Increased sleep(n=136,148) | 19.1 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=133,147) | 3.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) | Antipyretic medication to treat symptom(n=134,147) | 2.2 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=142,153) | 53.5 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 but =<39 degrees C(n=138,149) | 25.4 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=135,147) | 11.9 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=134,149) | 19.4 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=140,151) | 17.1 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) | Decreased appetite(n=135,147) | 5.4 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 but =<40.0 degrees C(n=135,147) | 0.0 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=142,153) | 38.6 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=133,147) | 0.7 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) | Decreased sleep(n=140,151) | 15.2 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=136,148) | 12.8 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 but =<39 degrees C(n=138,149) | 15.4 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=133,147) | 0.0 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=134,149) | 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) | Antipyretic medication to treat symptom(n=134,147) | 2.0 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 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 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 systemic event. '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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >39 but =<40.0 degrees C(n=118,138) | 1.7 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=118,139) | 10.2 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=119,141) | 16.0 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=120,140) | 6.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Fever >=37.5 but =<39 degrees C(n=120,141) | 19.2 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=118,138) | 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) | Decreased appetite(n=119,138) | 8.4 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=119,138) | 1.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) | Antipyretic medication to treat symptom(n=119,138) | 1.7 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=122,143) | 39.3 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) | Hives (urticaria)(n=119,138) | 0.0 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=118,138) | 0.0 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=118,139) | 7.2 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=122,143) | 36.4 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=119,141) | 18.4 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=119,138) | 6.5 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=120,140) | 14.3 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) | Antipyretic medication to treat symptom(n=119,138) | 2.2 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) | Fever >=37.5 but =<39 degrees C(n=120,141) | 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) | Fever >39 but =<40.0 degrees C(n=118,138) | 0.7 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 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 Catch-up Dose 1
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 event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Fever >=37.5 but =<39 degrees C(n=139) | 32.4 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Fever >39 but =<40.0 degrees C(n=135) | 2.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Fever >40 degrees C(n=135) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Decreased appetite(n=136) | 8.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Irritability(n=136) | 12.5 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Increased sleep(n=136) | 17.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Decreased sleep(n=136) | 11.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Hives (urticaria)(n=135) | 0.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Antipyretic medication to treat symptom(n=136) | 5.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) | Any systemic event(n=139) | 49.6 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 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 Catch-up Dose 2
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 event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Decreased appetite(n=138) | 10.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Irritability(n=138) | 11.6 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Fever >=37.5 but =<39 degrees C(n=140) | 32.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Fever >39 but =<40.0 degrees C(n=138) | 5.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Fever >40 degrees C(n=138) | 0.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Increased sleep(n=138) | 15.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Decreased sleep(n=139) | 10.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Hives (urticaria)(n=138) | 2.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Antipyretic medication to treat symptom(n=138) | 5.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) | Any systemic event(n=141) | 47.5 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 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 Catch-up Dose 3
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 event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Fever >40 degrees C(n=130) | 0.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Decreased appetite(n=130) | 6.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Irritability(n=131) | 9.2 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Increased sleep(n=131) | 10.7 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Any systemic event(n=136) | 39.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Fever >=37.5 but =<39 degrees C(n=134) | 26.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Fever >39 but =<40.0 degrees C(n=130) | 0.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Decreased sleep(n=131) | 6.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Hives (urticaria)(n=131) | 0.8 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) | Antipyretic medication to treat symptom(n=130) | 1.5 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 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 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 event. '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) |
|---|---|---|---|
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Increased sleep(n=103,135) | 20.4 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >39 but =<40.0 degrees C(n=99,132) | 5.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased sleep(n=101,133) | 10.9 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Decreased appetite(n=100,133) | 9.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Hives (urticaria)(n=98,133) | 1.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Fever >=37.5 but =<39 degrees C(n=103,135) | 34.0 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Antipyretic medication to treat symptom(n=98,133) | 4.1 Percentage of participants |
| 7vPnC + DTaP | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Irritability(n=100,134) | 17.0 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=108,138) | 52.8 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=98,132) | 1.0 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=108,138) | 39.9 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=98,132) | 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) | Fever >=37.5 but =<39 degrees C(n=103,135) | 22.2 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=100,133) | 8.3 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=100,134) | 9.7 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=103,135) | 15.6 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=101,133) | 7.5 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=98,133) | 0.8 Percentage of participants |
| DTaP (Catch-up 7vPnC) | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) | Antipyretic medication to treat symptom(n=98,133) | 4.5 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 but =<40.0 degrees C(n=99,132) | 2.3 Percentage of participants |