Vaccines, Pneumococcal
Conditions
Keywords
Vaccine
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
1 dose at 2,4,6 and 15 months of age
BIOLOGICAL7-valent pneumococcal conjugate vaccine
1 dose at 2,4,6 and 15 months of age
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2-month-old infants * Available for the entire study period
Exclusion criteria
* Previous vaccination with any vaccine before the start of the study * Known contraindication to vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed. |
| Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | Predefined antibody levels for Diphtheria (0.01 or 0.1 International units \[IU\]/mL) and Tetanus (0.01 or 0.1 \[IU\]/mL). |
| Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | — |
| Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series | One month after infant series dose (at 5 months of age) | Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented. |
| Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose | One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | One month after toddler dose (at 16 months of age) | Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Systemic Events | During the 4-day period after each dose | Systemic events (fever \[Fv\] ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Local Reactions | During the 4-day period after each dose | Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (\>7.0 cm). Participants may be represented in more than 1 category. |
Countries
Spain
Participant flow
Recruitment details
Participants were recruited in Spain from 4 July 2007 to 23 July 2007.
Pre-assignment details
Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. | 219 |
| 7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. | 225 |
| Total | 444 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Lost to Follow-up | 3 | 0 |
| After Infant Series | Withdrawal by Subject | 1 | 0 |
| Infant Series | Lost to Follow-up | 2 | 1 |
| Infant Series | Protocol Violation | 0 | 1 |
| Infant Series | Randomization error | 5 | 0 |
| Infant Series | Withdrawal by Subject | 3 | 4 |
| Toddler Dose | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.1 months STANDARD_DEVIATION 0.4 | 2.0 months STANDARD_DEVIATION 0.4 | 2.1 months STANDARD_DEVIATION 0.4 |
| Sex: Female, Male Female | 104 Participants | 116 Participants | 220 Participants |
| Sex: Female, Male Male | 115 Participants | 109 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 204 / 218 | 211 / 225 | 6 / 218 | 13 / 225 | 171 / 209 | 179 / 218 | 4 / 218 | 2 / 224 |
| serious Total, serious adverse events | 6 / 218 | 8 / 226 | 9 / 218 | 6 / 226 | 1 / 218 | 0 / 226 | 4 / 218 | 9 / 226 |
Outcome results
Primary
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
Time frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 7F | 1.51 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 3 | 0.54 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 19F | 2.98 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 9V | 1.15 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 1 | 1.87 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 23F | 0.40 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 4 | 1.55 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 6B | 0.21 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 6A | 0.81 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 14 | 1.94 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 19A | 1.52 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 5 | 0.88 μg/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 18C | 1.30 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 23F | 1.67 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 4 | 2.32 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 6B | 2.59 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 9V | 1.51 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 14 | 4.51 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 18C | 1.86 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 19F | 2.46 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 1 | 2.95 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 3 | 0.85 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 5 | 1.83 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 6A | 3.08 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 7F | 3.41 μg/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 19A | 2.50 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 3 | 1.04 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 14 | 9.82 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 7F | 5.66 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 5 | 3.69 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 9V | 2.67 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 4 | 3.88 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 6A | 7.71 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 23F | 3.96 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 19F | 6.11 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 6B | 12.25 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 1 | 4.60 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 18C | 2.29 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 19A | 10.21 μg/mL |
Primary
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Population: The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria | 0.79 IU/mL |
| 13vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus | 1.10 IU/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus | 1.20 IU/mL |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria | 0.92 IU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria | 3.00 IU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus | 3.29 IU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria | 3.23 IU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus | 3.28 IU/mL |
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.72, 1.03]
Comparison: For tetanus the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.74, 1.12]
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.78, 1.1]
Comparison: For tetanus the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.81, 1.24]
Primary
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
Time frame: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Population: The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC After Infant Series Dose 2 | Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose | 654.55 titer |
| 7vPnC After Infant Series Dose 2 | Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose | 757.04 titer |
| 13vPnC Dose 2 | Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose | 2573.06 titer |
| 7vPnC Dose 2 | Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose | 2098.12 titer |
Comparison: For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.69, 1.08]
Comparison: For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.97, 1.55]
Primary
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 7F | 94.5 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 3 | 73.8 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 19F | 100.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 9V | 89.9 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 1 | 96.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 23F | 55.8 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 4 | 92.5 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 6B | 27.9 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 6A | 80.8 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 14 | 91.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 19A | 92.9 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 5 | 86.4 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 18C | 88.9 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 23F | 93.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 4 | 98.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 6B | 94.9 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 9V | 97.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 14 | 97.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 18C | 99.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 19F | 99.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 1 | 98.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 3 | 86.2 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 5 | 96.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 6A | 99.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 7F | 100.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 19A | 99.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 3 | 93.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 14 | 99.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 7F | 99.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 5 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 9V | 99.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 4 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 6A | 99.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 23F | 98.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 19F | 98.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 6B | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 1 | 98.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotypes - Serotype 18C | 98.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotypes - Serotype 19A | 100.0 percentage of participants |
Primary
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Time frame: One month after infant series dose (at 5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series | 98.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series | 99.1 percentage of participants |
Comparison: For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at \>=1:8 titer was calculated95% CI: [-3.3, 2]
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units \[IU\]/mL) and Tetanus (0.01 or 0.1 \[IU\]/mL).
Time frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Population: The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.10 IU/mL | 98.5 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.10 IU/mL | 96.6 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.10 IU/mL | 96.7 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.10 IU/mL | 99.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.10 IU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.10 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.10 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Diphtheria ≥0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Tetanus ≥0.10 IU/mL | 100.0 percentage of participants |
Comparison: For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated95% CI: [-3.5, 2]
Comparison: For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated95% CI: [-1.9, 1.7]
Comparison: For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated95% CI: [-4.4, 4]
Comparison: For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated95% CI: [-2.1, 2]
Comparison: For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated95% CI: [-2.2, 2.2]
Comparison: For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated95% CI: [-2.2, 2.2]
Comparison: For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated95% CI: [-2.3, 2.2]
Comparison: For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated95% CI: [-2.3, 2.2]
Secondary
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Time frame: One month after toddler dose (at 16 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | 100.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | 99.4 percentage of participants |
Comparison: For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.95% CI: [-1.7, 3.2]
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 2.6 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 12.2 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 0.5 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 3.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 21.1 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 14.7 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 15.2 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 13.3 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 18.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 13.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 2.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 15.1 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 1.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 14.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 14.1 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 4.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 1.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 21.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 22.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 20.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 2.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 23.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 22.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 2.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 2.3 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 1.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 20.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 13.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 16.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 19.4 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 14.7 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 4.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 1.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 26.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 6.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 20.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 10.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 3.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 23.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 24.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 17.1 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 6.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 1.2 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 22.7 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 21.1 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 14.3 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 3.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 20.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 9.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 28.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 28.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 2.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 9.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 26.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 30.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 22.9 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=196,197,178,175,166,169,157,163) | 6.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=196,196,177,175,166,168,156,163) | 5.5 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=197,198,180,180,172,171,167,165) | 21.2 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=196,200,182,177,171,170,169,168) | 18.5 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=196,196,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=199,205,182,180,170,175,164,172) | 26.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=197,199,181,180,172,172,170,169) | 23.1 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=199,200,177,177,167,169,154,160) | 3.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=196,200,182,177,171,170,166,168) | 16.0 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever \[Fv\] ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 41.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 31.4 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 19.4 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 38.7 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 41.3 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 1.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 46.5 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 22.9 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 19.6 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 35.7 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 44.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 49.8 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 45.7 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 0.5 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 39.3 percentage of participants |
| 7vPnC After Infant Series Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 27.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 39.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 47.9 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 1.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 32.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 54.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 46.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 27.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 57.3 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 44.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 60.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 57.9 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 1.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 49.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 27.8 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 41.8 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 36.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 43.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 20.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 3.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 37.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 21.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 22.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 39.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 44.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 3.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 29.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 25.3 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 36.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 40.5 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 39.4 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 42.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 27.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 50.3 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 31.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 41.5 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 19.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 31.9 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 4.5 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 43.5 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 16.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=201,210,194,196,177,185,168,177) | 41.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=204,206,189,187,175,174,162,165) | 24.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=204,207,189,191,178,178,163,178) | 41.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=196,197,177,175,166,168,152,156) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=196,204,183,187,175,178,162,166) | 18.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) | 2.6 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=205,209,193,197,175,189,165,177) | 46.9 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) | 34.3 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=202,211,192,190,179,188,171,179) | 53.6 percentage of participants |