Vaccines, Pneumococcal
Conditions
Keywords
Pneumococcal, Pediatric, 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 pediatric vaccinations in Spain.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
BIOLOGICAL7-valent Pneumococcal Conjugate Vaccine
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
* 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 |
|---|---|---|
| Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | One month after 2-doses of the infant series (5 months of age) | Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented. |
| Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | One month after 2-doses of the infant series (5 months of age) | — |
| Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | One month after 2-doses of the infant series (5 months of age) | — |
| 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 (\>7.0 cm). Participants may be represented in more than 1 category. |
| 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 \[Med\] 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. |
| Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After 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 which are present in both 7vPnC and 13vPnC (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 Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) | Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented. |
| Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) | — |
| Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) | — |
| Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) | GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. |
| Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After 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 ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (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. |
Countries
Spain
Participant flow
Recruitment details
Participants were recruited in Spain from October 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 Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec. | 315 |
| 7vPnC Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec. | 304 |
| Total | 619 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant | Adverse Event | 1 | 2 |
| After Infant | Death | 1 | 0 |
| After Infant | Failed to return | 3 | 1 |
| After Infant | Lost to Follow-up | 0 | 1 |
| After Infant | Withdrawal by Subject | 1 | 1 |
| Infant Series | Adverse Event | 0 | 1 |
| Infant Series | Failed to meet eligibility criteria | 0 | 1 |
| Infant Series | Failed to return | 1 | 0 |
| Infant Series | Lost to Follow-up | 2 | 0 |
| Infant Series | Protocol Violation | 2 | 1 |
| Infant Series | Randomization error | 0 | 1 |
| Infant Series | Withdrawal by Subject | 11 | 6 |
| Toddler Dose | Lost to Follow-up | 0 | 2 |
| Toddler Dose | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | 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 | 148 Participants | 152 Participants | 300 Participants |
| Sex: Female, Male Male | 167 Participants | 152 Participants | 319 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 | 151 / 314 | 156 / 300 | 7 / 314 | 10 / 300 | 124 / 291 | 110 / 284 | 3 / 312 | 2 / 299 |
| serious Total, serious adverse events | 16 / 314 | 16 / 300 | 16 / 314 | 16 / 300 | 3 / 291 | 1 / 284 | 3 / 312 | 6 / 299 |
Outcome results
Primary
Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Time frame: One month after 2-doses of the infant series (5 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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | 0.51 IU/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | 0.63 IU/mL |
Comparison: For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.7, 0.94]
Primary
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After 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 which are present in both 7vPnC and 13vPnC (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; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 19A (n=267,267,226) | 2.36 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 4 (n=269,269,241) | 1.89 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 6B (n=267,267,228) | 0.42 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 9V (n=273,273,241) | 1.49 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 14 (n=270,270,230) | 3.84 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 18C (n=267,267,239) | 1.58 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 19F (n=270,270,231) | 2.85 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 23F (n=260,260,233) | 0.54 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 1 (n=268,268,235) | 1.90 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 3 (n=267,267,243) | 0.79 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 5 (n=261,261,234) | 0.99 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 6A (n=269,269,235) | 1.10 μg/mL |
| 13vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 7F (n=268,268,242) | 1.85 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 19A (n=267,267,226) | 3.07 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 18C (n=267,267,239) | 2.29 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 6A (n=269,269,235) | 3.16 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 19F (n=270,270,231) | 2.64 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 23F (n=260,260,233) | 2.15 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 1 (n=268,268,235) | 3.04 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 7F (n=268,268,242) | 4.03 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 3 (n=267,267,243) | 0.97 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 4 (n=269,269,241) | 2.33 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 6B (n=267,267,228) | 3.88 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 5 (n=261,261,234) | 1.93 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 9V (n=273,273,241) | 1.71 μg/mL |
| 7vPnC | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 14 (n=270,270,230) | 6.17 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 5 (n=261,261,234) | 3.90 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 3 (n=267,267,243) | 1.07 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 18C (n=267,267,239) | 3.96 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 14 (n=270,270,230) | 11.37 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 4 (n=269,269,241) | 4.97 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 19F (n=270,270,231) | 8.04 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 6A (n=269,269,235) | 7.07 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 7F (n=268,268,242) | 5.78 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 23F (n=260,260,233) | 5.07 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 19A (n=267,267,226) | 11.64 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 9V (n=273,273,241) | 3.44 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 1 (n=268,268,235) | 4.79 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 6B (n=267,267,228) | 11.88 μg/mL |
Comparison: For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.13, 1.35]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [8.18, 10.53]
Comparison: For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.05, 1.25]
Comparison: For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.41, 1.83]
Comparison: For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.3, 1.61]
Comparison: For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [0.83, 1.03]
Comparison: For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [3.55, 4.5]
Comparison: For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.46, 1.76]
Comparison: For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.13, 1.35]
Comparison: For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.78, 2.11]
Comparison: For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [2.58, 3.2]
Comparison: For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.98, 2.41]
Comparison: For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.95% CI: [1.18, 1.44]
Primary
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Time frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (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 | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diphtheria | 1.19 IU/mL |
| 13vPnC | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus | 0.90 IU/mL |
| 7vPnC | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus | 0.87 IU/mL |
| 7vPnC | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diphtheria | 1.40 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 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 the Toddler Dose | Tetanus | 1.63 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 the Toddler Dose | Diphtheria | 3.51 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 the Toddler Dose | Tetanus | 1.45 IU/mL |
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.75, 0.96]
Comparison: For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.88, 1.2]
Comparison: For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.71, 1.02]
Comparison: For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.9, 1.4]
Primary
Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.
Time frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (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 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PT | 51.51 EU/mL |
| 13vPnC | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PRN | 141.39 EU/mL |
| 13vPnC | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis FHA | 179.04 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PT | 50.13 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PRN | 135.06 EU/mL |
| 7vPnC | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis FHA | 166.77 EU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis FHA | 347.96 EU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PT | 36.13 EU/mL |
| 13vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PRN | 232.96 EU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PT | 36.01 EU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis PRN | 261.58 EU/mL |
| 7vPnC Dose 2 | Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis FHA | 345.89 EU/mL |
Comparison: For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.93, 1.13]
Comparison: For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.96, 1.2]
Comparison: For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.92, 1.18]
Comparison: For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.88, 1.14]
Comparison: For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.88, 1.15]
Comparison: For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.78, 1.02]
Primary
Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Time frame: One month after 2-doses of the infant series (5 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 | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC | Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | 191.22 titer |
| 7vPnC | Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | 266.19 titer |
Comparison: For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.6, 0.86]
Primary
Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Time frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (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 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 1 | 436.98 titer |
| 13vPnC | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 3 | 897.67 titer |
| 13vPnC | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 2 | 266.34 titer |
| 7vPnC | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 1 | 436.15 titer |
| 7vPnC | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 3 | 943.95 titer |
| 7vPnC | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 2 | 281.85 titer |
| 13vPnC Dose 2 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 2 | 1032.30 titer |
| 13vPnC Dose 2 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 1 | 1057.40 titer |
| 13vPnC Dose 2 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 3 | 2571.10 titer |
| 7vPnC Dose 2 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 1 | 1286.70 titer |
| 7vPnC Dose 2 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 3 | 2410.80 titer |
| 7vPnC Dose 2 | Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus Type 2 | 1141.10 titer |
Comparison: For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.82, 1.23]
Comparison: For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.76, 1.18]
Comparison: For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.76, 1.19]
Comparison: For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.69, 0.98]
Comparison: For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.75, 1.09]
Comparison: For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated95% CI: [0.88, 1.29]
Primary
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After 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 ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (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 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 7F | 98.5 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 3 | 88.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 19F | 97.8 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 9V | 91.9 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 1 | 96.3 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 23F | 68.1 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 4 | 96.7 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 6B | 57.3 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 6A | 84.4 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 14 | 98.5 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 19A | 98.1 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 5 | 87.4 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 18C | 91.8 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 23F | 94.6 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 4 | 98.9 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 6B | 98.5 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 9V | 99.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 14 | 97.4 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 18C | 98.1 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 19F | 99.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 1 | 99.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 3 | 90.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 5 | 97.3 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 6A | 97.4 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 7F | 100.0 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 19A | 99.6 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 3 | 92.2 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 14 | 100.0 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 7F | 98.8 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 5 | 99.1 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 9V | 100.0 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 4 | 99.2 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 6A | 99.1 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 23F | 99.1 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 19F | 99.6 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 6B | 99.6 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 1 | 98.7 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Common Serotype - Serotype 18C | 99.6 Percentage of Participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | Additional Serotype - Serotype 19A | 100.0 Percentage of Participants |
Comparison: For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [0.1, 4.4]
Comparison: For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [34.9, 46.9]
Comparison: For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [4.1, 10.4]
Comparison: For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [-3.4, 1.2]
Comparison: For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [3.1, 9.5]
Comparison: For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [-0.4, 3.4]
Comparison: For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [20.7, 31.9]
Comparison: For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [0.8, 5.1]
Comparison: For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [-1.8, 6.3]
Comparison: For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [5.9, 13.9]
Comparison: For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [8.6, 17.2]
Comparison: For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [-0.1, 3.1]
Comparison: For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated95% CI: [-0.4, 3.4]
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.
Time frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (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 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 7.82 EU/mL | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN (Infant ≥ 39; Toddler ≥ 69) EU/mL | 94.5 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN ≥ 5 EU/mL | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA (Infant ≥ 64; Toddler ≥ 99) EU/mL | 93.9 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 3 ≥ 1:8 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 2 ≥ 1:8 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT (Infant ≥ 20; Toddler ≥ 11) EU/mL | 93.2 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 1 ≥ 1:8 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.10 IU/mL | 98.6 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 5.0 EU/mL | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT ≥ 5.0 EU/mL | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.10 IU/mL | 99.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT (Infant ≥ 20; Toddler ≥ 11) EU/mL | 95.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT ≥ 5.0 EU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 5.0 EU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 7.82 EU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA (Infant ≥ 64; Toddler ≥ 99) EU/mL | 95.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN ≥ 5 EU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN (Infant ≥ 39; Toddler ≥ 69) EU/mL | 95.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.10 IU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.10 IU/mL | 98.2 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 1 ≥ 1:8 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 2 ≥ 1:8 | 99.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 3 ≥ 1:8 | 99.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.10 IU/mL | 99.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 3 ≥ 1:8 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 5.0 EU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 1 ≥ 1:8 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA (Infant ≥ 64; Toddler ≥ 99) EU/mL | 94.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.10 IU/mL | 98.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 7.82 EU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 2 ≥ 1:8 | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN ≥ 5 EU/mL | 100.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT (Infant ≥ 20; Toddler ≥ 11) EU/mL | 94.9 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN (Infant ≥ 39; Toddler ≥ 69) EU/mL | 93.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT ≥ 5.0 EU/mL | 99.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN (Infant ≥ 39; Toddler ≥ 69) EU/mL | 95.2 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.10 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Diptheria ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT (Infant ≥ 20; Toddler ≥ 11) EU/mL | 96.3 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 2 ≥ 1:8 | 99.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.10 IU/mL | 97.8 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Tetanus ≥ 0.01 IU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PRN ≥ 5 EU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 3 ≥ 1:8 | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 7.82 EU/mL | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA (Infant ≥ 64; Toddler ≥ 99) EU/mL | 95.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Poliovirus, Type 1 ≥ 1:8 | 100.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, PT ≥ 5.0 EU/mL | 99.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose | Pertussis, FHA ≥ 5.0 EU/mL | 100.0 percentage of participants |
Comparison: For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated95% CI: [-1.3, 1.3]
Comparison: For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated95% CI: [-6, 2]
Comparison: For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated95% CI: [-1.3, 1.3]
Comparison: For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated95% CI: [-1.3, 1.3]
Comparison: For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated95% CI: [-5.2, 2.6]
Comparison: For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated95% CI: [-1.3, 1.3]
Comparison: For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated95% CI: [-4.4, 3.2]
Comparison: For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated95% CI: [-1.7, 1.7]
Comparison: For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated95% CI: [-5.1, 2.2]
Comparison: For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated95% CI: [-4.6, 3.3]
Comparison: For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated95% CI: [-5.8, 2.3]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated95% CI: [-2.5, 0.7]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated95% CI: [-1.3, 1.3]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated95% CI: [-2.8, 0.8]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated95% CI: [-1.5, 1.5]
Comparison: For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated95% CI: [-2.1, 2.9]
Comparison: For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated95% CI: [-1.3, 1.3]
Comparison: For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated95% CI: [-2.1, 3.8]
Comparison: For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated95% CI: [-1.8, 1.7]
Comparison: For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated95% CI: [-1.4, 1.3]
Comparison: For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated95% CI: [-0.6, 2.6]
Comparison: For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated95% CI: [-1, 2]
Comparison: For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated95% CI: [-1.5, 1.5]
Comparison: For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated95% CI: [-1.1, 2.2]
Comparison: For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated95% CI: [-1.5, 1.5]
Primary
Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.
Time frame: One month after 2-doses of the infant series (5 months of age)
Population: 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 | Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | Diptheria ≥ 0.01 IU/mL | 100.0 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | Meningococcal C ≥ 1:8 | 98.3 Percentage of Participants |
| 13vPnC | Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | Diptheria ≥ 0.10 IU/mL | 95.9 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | Diptheria ≥ 0.10 IU/mL | 94.7 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | Meningococcal C ≥ 1:8 | 98.9 Percentage of Participants |
| 7vPnC | Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series | Diptheria ≥ 0.01 IU/mL | 100.0 Percentage of Participants |
Comparison: For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated95% CI: [-2.9, 1.6]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated95% CI: [-2.3, 4.9]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated95% CI: [-1.3, 1.3]
Primary
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 (\>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 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 2.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 4.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 19.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 49.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 20.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 22.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 16.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 2.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 19.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 2.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 14.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 1.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 14.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 43.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 18.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 1.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 3.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 45.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 25.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 32.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 34.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 4.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 5.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 28.2 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 2.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 4.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 46.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 30.2 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 23.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 20.3 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 30.9 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 3.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 27.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 47.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 6.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 26.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 5.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 31.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 29.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 4.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 33.3 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 34.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 28.2 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 4.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 41.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 5.1 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 25.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 11.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 40.9 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 31.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 35.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 33.3 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 13.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 64.2 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 5.9 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=247,248,191,201,180,173,136,124) | 12.9 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=247,247,192,203,177,175,137,120) | 12.5 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=275,270,227,232,217,215,193,170) | 64.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=255,251,211,217,203,198,159,146) | 41.1 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=254,251,210,215,203,195,157,141) | 37.6 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=252,254,206,212,203,181,153,140) | 30.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=247,250,192,203,181,171,136,118 | 6.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe (n=246,247,191,201,176,171,131,113) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=251,254,206,212,201,186,151,132) | 24.2 percentage of participants |
Primary
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 \[Med\] 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 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 50.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 53.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 49.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 51.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 0.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 34.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 39.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 30.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 36.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 47.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 46.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 24.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 51.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 24.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 0.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 42.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 40.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 60.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 2.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 58.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 45.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 64.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 46.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 36.2 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 41.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 61.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 44.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 2.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 29.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 58.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 41.7 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 61.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 47.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 33.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 56.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 30.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 5.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 57.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 34.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 55.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 58.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 55.5 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 42.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 53.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 38.3 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 25.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 5.2 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 34.5 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 59.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 38.9 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 8.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 53.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 61.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 39.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 27.2 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 59.6 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx (n=267,256,232,243,216,209,176,163) | 60.1 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=276,267,234,244,229,221,183,170) | 61.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite (n=269,258,226,229,219,204,174,147) | 47.6 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=249,247,192,201,176,171,132,113) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118) | 6.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145) | 44.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=263,255,218,223,205,190,151,129) | 27.1 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=273,269,218,221,206,203,160,145) | 35.2 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx (n=269,258,231,237,222,211,178,159) | 61.6 percentage of participants |