Vaccines, Pneumococcal
Conditions
Keywords
Vaccine, Infant
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
Interventions
BIOLOGICAL13 valent pneumococcal conjugate vaccine with Polysorbate 80
BIOLOGICAL13 valent pneumococcal conjugate vaccine without Polysorbate 80
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
1. Aged 2 months (42 through 98 days) at the time of enrollment. 2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone. 3. In good health as determined by medical history, physical examination, and judgment of the investigator. 4. Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.
Exclusion criteria
1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression. 7. History of culture-proven invasive disease caused by S pneumoniae. 8. Major known congenital malformation or serious chronic disorder. 9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy. 10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies \[eg, Synagis\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | One month after 3-dose infant series (at 5 months of age) | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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. |
| Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | One month after 3-dose infant series (at 5 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | one month after the toddler dose (at 13 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. |
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | one month after the toddler dose (at 13 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Reporting Pre-Specified Local Reactions | Within 4-days 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 (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events | Within 4-days 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. |
Countries
Poland
Participant flow
Recruitment details
Participants were recruited in Poland from November 2006 to December 2006.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC With (+) Polysorbate 80 Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). | 250 |
| 13vPnC Without (-) Polysorbate 80 Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 2 | 0 |
| After Infant Series | Lost to Follow-up | 1 | 0 |
| After Infant Series | Withdrawal by Subject | 3 | 1 |
| Infant Series | Adverse Event | 1 | 3 |
| Infant Series | Protocol Violation | 0 | 1 |
| Infant Series | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | 13vPnC With (+) Polysorbate 80 | 13vPnC Without (-) Polysorbate 80 | Total |
|---|---|---|---|
| Age Continuous | 2.1 months STANDARD_DEVIATION 0.5 | 2.1 months STANDARD_DEVIATION 0.5 | 2.1 months STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 122 Participants | 122 Participants | 244 Participants |
| Sex: Female, Male Male | 128 Participants | 128 Participants | 256 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 | 132 / 249 | 132 / 250 | 15 / 249 | 9 / 250 | 91 / 239 | 111 / 244 | 0 / 249 | 1 / 250 |
| serious Total, serious adverse events | 15 / 249 | 21 / 250 | 24 / 249 | 16 / 250 | 3 / 239 | 2 / 244 | 13 / 249 | 14 / 250 |
Outcome results
Primary
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
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.
Time frame: One month after 3-dose infant series (at 5 months of age)
Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 1.46 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 1.39 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 1.84 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 1.50 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 0.51 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 1.26 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 1.46 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 0.99 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 2.37 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 1.98 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 0.93 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 2.68 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 | 1.47 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 2.94 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 | 1.53 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 0.57 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 1.51 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 2.48 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 1.87 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 1.75 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 1.11 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 1.48 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 1.62 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 1.30 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 1.04 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 1.89 μg/mL |
Comparison: For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.81, 1.13]
Comparison: For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.72, 1.14]
Comparison: For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.85, 1.1]
Comparison: For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.79, 1.15]
Comparison: For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.86, 1.13]
Comparison: For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.72, 0.97]
Comparison: For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.71, 0.98]
Comparison: For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.81, 1.1]
Comparison: For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.83, 1.04]
Comparison: For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.83, 1.13]
Comparison: For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.81, 1.13]
Comparison: For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.93, 1.18]
Comparison: For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.8, 1.04]
Primary
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 3-dose infant series (at 5 months of age)
Population: Evaluable immunogenicity population 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 serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 9V (n=231,232) | 97.1 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 1 (n=228,220) | 95.8 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 18C (n=233,233) | 97.9 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 3 (n=233,236) | 97.9 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 6B (n=145,158) | 60.9 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 5 (n=224,220) | 94.1 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 19F (n=228,234) | 95.8 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 6A (n=206,205) | 86.6 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 14 (n=225,232) | 94.5 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 7F (n=235,237) | 98.7 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 23F (n=205,220) | 86.1 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 19A (n=235,238) | 98.7 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 4 (n=222,224) | 93.3 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 19A (n=235,238) | 100.0 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 4 (n=222,224) | 94.1 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 6B (n=145,158) | 66.4 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 9V (n=231,232) | 97.5 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 14 (n=225,232) | 97.5 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 18C (n=233,233) | 97.9 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 19F (n=228,234) | 98.3 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Common Serotypes - Serotype 23F (n=205,220) | 92.4 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 1 (n=228,220) | 92.4 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 3 (n=233,236) | 99.2 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 5 (n=224,220) | 92.4 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 6A (n=206,205) | 86.1 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Additional Serotypes - Serotype 7F (n=235,237) | 99.6 percentage of participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-5.4, 3.7]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-14.2, 3.3]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3.7, 2.8]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-6.9, 0.7]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3, 3]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-6.1, 0.6]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-12.1, -0.7]
Comparison: For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-0.9, 7.9]
Comparison: For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.1, 1.1]
Comparison: For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3, 6.4]
Comparison: For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-5.8, 6.7]
Comparison: For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3.2, 1.2]
Comparison: For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3.6, 0.3]
Secondary
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative 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.
Time frame: one month after the toddler dose (at 13 months of age)
Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 9V (n=226,238) | 3.01 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 1 (n=226,238) | 6.03 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 18C (n=226,238) | 3.40 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 3 (n=213,226) | 1.09 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 6B (n=221,228) | 9.89 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 5 (n=225,234) | 3.80 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 19F (n=223,236) | 9.63 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 6A (n=224,236) | 7.48 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 14 (n=224,238) | 11.72 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 7F (n=226,238) | 5.36 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 23F (n=223,236) | 3.88 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 19A (n=224,236) | 13.20 μg/mL |
| 13vPnC + Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 4 (n=226,238) | 5.25 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 19A (n=224,236) | 13.02 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 4 (n=226,238) | 5.38 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 6B (n=221,228) | 10.65 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 9V (n=226,238) | 3.10 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 14 (n=224,238) | 11.95 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 18C (n=226,238) | 3.10 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 19F (n=223,236) | 10.27 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 23F (n=223,236) | 4.15 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 1 (n=226,238) | 6.11 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 3 (n=213,226) | 1.16 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 5 (n=225,234) | 3.98 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 6A (n=224,236) | 8.19 μg/mL |
| 13vPnC - Polysorbate 80 After the Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 7F (n=226,238) | 4.95 μg/mL |
Secondary
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group 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 the toddler dose (at 13 months of age)
Population: Evaluable immunogenicity population 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 serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=226,238) | 99.6 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=226,238) | 100.0 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=226,238) | 100.0 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=223,236) | 95.1 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=225,237) | 99.6 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=226,238) | 99.6 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=226,237) | 99.1 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=226,237) | 99.6 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=226,238) | 99.6 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=226,238) | 100.0 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=226,238) | 98.7 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=226,238) | 100.0 percentage of participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=226,238) | 99.6 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=226,238) | 100.0 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=226,238) | 99.6 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=225,237) | 99.2 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=226,238) | 100.0 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=226,238) | 99.6 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=226,238) | 99.6 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=226,237) | 98.7 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=226,238) | 99.6 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=226,238) | 99.2 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=223,236) | 94.5 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=226,238) | 100.0 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=226,237) | 100.0 percentage of participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=226,238) | 100.0 percentage of participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.95% CI: [-2.1, 1.9]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.95% CI: [-1.7, 2.6]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.4, 1.1]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.1, 1.9]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-1.2, 2.3]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2, 2.9]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3.4, 1.1]
Comparison: For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-0.8, 3]
Comparison: For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-3.7, 4.9]
Comparison: For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.4, 1.1]
Comparison: For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.4, 1.2]
Comparison: For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-1.7, 1.6]
Comparison: For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-1.7, 1.6]
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: Within 4-days 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 + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 14.5 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 55.0 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 14.0 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 0.4 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 35.7 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 14.0 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 46.3 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 21.5 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 55.2 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 15.8 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 0.4 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 16.2 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 52.5 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 29.7 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 22.4 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 16.6 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 16.3 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 15.3 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 18.3 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 51.7 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 0.9 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 35.9 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 16.4 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 24.7 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 17.0 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 0.5 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 26.4 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 39.3 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 15.2 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 24.1 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 16.8 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 53.9 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 15.1 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 15.1 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 25.8 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 45.6 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 25.4 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 19.7 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 1.0 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 21.4 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 27.6 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 0.9 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 20.7 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 50.0 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 24.4 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 14.7 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 10.6 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 20.6 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 49.5 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 26.2 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 19.0 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 18.7 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 2.5 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 19.4 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 22.9 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 21.5 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=237,237,221,224,210,222,172,183) | 29.0 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=242,242,231,229,209,221,174,182) | 30.8 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=240,239,232,232,215,226,184,198) | 56.1 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172) | 18.0 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-prevent sx(n=235,234,220,223,205,217,171,171) | 15.2 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Meds-treat sx (n=236,235,222,226,205,218,172,168) | 15.5 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=235,233,221,221,203,211,160,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164) | 1.8 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=238,236,227,227,209,217,170,180) | 25.6 Percentage of Participants |
Other Pre-specified
Percent 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 (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4-days 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 + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 11.9 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 29.8 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 2.1 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 18.2 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 28.2 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 27.7 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 22.9 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 2.1 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 39.5 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 24.2 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 35.7 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 4.3 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 4.3 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 32.9 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 30.5 Percentage of Participants |
| 13vPnC - Polysorbate 80 After the Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 14.4 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 38.4 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 0.9 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 25.0 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 26.8 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 20.3 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 1.4 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 11.2 Percentage of Participants |
| 13vPnC + P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 38.8 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 32.8 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 3.2 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 36.4 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 14.3 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 0.5 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 47.0 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 48.5 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Dose 2 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 31.9 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 32.5 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 46.5 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 36.7 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 3.9 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 46.8 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 13.9 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 24.8 Percentage of Participants |
| 13vPnC + P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 1.5 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 9.0 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 23.1 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 1.9 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 38.2 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 33.5 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 17.5 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 50.0 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 46.9 Percentage of Participants |
| 13vPnC - P80 Dose 3 Infant Series | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 42.1 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 35.8 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 12.2 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 26.6 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 12.8 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 29.9 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 2.5 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 42.1 Percentage of Participants |
| 13vPnC + P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=238,237,228,229,210,216,178,188) | 43.1 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=235,232,220,222,206,211,164,173) | 19.7 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=238,238,232,231,216,226,178,200) | 52.0 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=238,235,232,230,215,226,176,194) | 46.4 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=236,236,224,224,208,217,164,171) | 19.9 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=235,233,220,221,203,211,160,165) | 1.2 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=236,236,227,226,209,221,169,178) | 29.8 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=235,231,220,221,203,211,159,164) | 0.6 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=236,239,228,228,210,225,174,181) | 34.8 Percentage of Participants |
| 13vPnC - P80 Toddler Dose | Percent of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=235,233,220,221,203,211,159,164) | 0.0 Percentage of Participants |