Vaccines, Pneumococcal
Conditions
Keywords
Safety, 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 vaccines in France.
Interventions
BIOLOGICAL7-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
BIOLOGICAL13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
DRUGPentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2-month-old infants. * Available for the entire study period.
Exclusion criteria
· Known contraindication to vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | One month after the 3-Dose Infant Series (at 5 months of age) | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. |
| Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) | — |
| Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | One month after the 3-Dose Infant Series (at 5 months of age) | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| 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 (Tender)was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (Sev) (\>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 Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) | — |
| Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group | One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) | — |
| Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) | Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented. |
| Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | One month after the Toddler Dose (at 13 months of age) | Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | One month after the toddler dose (at 13 months of age) | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | One month after the toddler dose (at 13 months of age) | GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | One month after the toddler dose (at 13 months of age) | Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
Countries
France
Participant flow
Recruitment details
Participants were recruited in France from October 2006 to July 2007.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC/13vPnC Vaccine Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose). | 304 |
| 7vPnC/7vPnC Vaccine Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose). | 309 |
| Total | 613 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| After Infant | Adverse Event | 1 | 0 | 0 |
| After Infant | Failed to return | 5 | 5 | 0 |
| After Infant | Lost to Follow-up | 2 | 1 | 0 |
| After Infant | Protocol Violation | 1 | 0 | 0 |
| After Infant | Withdrawal by Subject | 8 | 4 | 0 |
| Infant Series | Adverse Event | 1 | 0 | 0 |
| Infant Series | Failed to return | 1 | 1 | 0 |
| Infant Series | Protocol Violation | 4 | 3 | 0 |
| Infant Series | Withdrawal by Subject | 8 | 6 | 0 |
| Toddler Dose | Failed to return | 1 | 0 | 0 |
| Toddler Dose | protocol deviation | 1 | 0 | 0 |
| Toddler Dose | Protocol Violation | 2 | 1 | 0 |
| Toddler Dose | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 13vPnC/13vPnC Vaccine | 7vPnC/7vPnC Vaccine | 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 | 169 Participants | 164 Participants | 333 Participants |
| Sex: Female, Male Male | 135 Participants | 145 Participants | 280 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 142 / 304 | 162 / 309 | 12 / 290 | 11 / 299 | 125 / 272 | 64 / 152 | 63 / 137 | 2 / 267 | 2 / 150 | 2 / 133 |
| serious Total, serious adverse events | 5 / 304 | 5 / 309 | 8 / 290 | 5 / 299 | 2 / 273 | 0 / 152 | 2 / 134 | 6 / 267 | 1 / 150 | 0 / 133 |
Outcome results
Primary
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA | 97.12 EU/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT | 62.94 EU/mL |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT | 68.20 EU/mL |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA | 111.23 EU/mL |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA | 204.28 EU/mL |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT | 61.09 EU/mL |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA | 241.08 EU/mL |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT | 61.70 EU/mL |
Comparison: For Pertussis - FHA the GMC ratio was calculated95% CI: [0.78, 0.98]
Comparison: For Pertussis - PT the GMC ratio was calculated95% CI: [0.84, 1.02]
Comparison: For Pertussis - FHA the GMC ratio was calculated95% CI: [0.72, 1]
Comparison: For Pertussis - PT the GMC ratio was calculated95% CI: [0.86, 1.14]
Primary
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Diphtheria | 0.19 IU/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Tetanus | 0.20 IU/mL |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Tetanus | 0.21 IU/mL |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Diphtheria | 0.24 IU/mL |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Diphtheria | 2.09 IU/mL |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Tetanus | 1.08 IU/mL |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Diphtheria | 2.60 IU/mL |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group | Tetanus | 1.25 IU/mL |
Comparison: For Diphtheria the GMC ratio was calculated95% CI: [0.66, 0.9]
Comparison: For Tetanus the GMC ratio was calculated95% CI: [0.82, 1.08]
Comparison: For Diphtheria the GMC ratio was calculated95% CI: [0.67, 0.97]
Comparison: For Tetanus the GMC ratio was calculated95% CI: [0.69, 1.08]
Primary
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 | 17.75 titer |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 | 24.99 titer |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 | 41.08 titer |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 | 21.55 titer |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 | 28.33 titer |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 | 52.95 titer |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 | 408.34 titer |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 | 253.05 titer |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 | 536.32 titer |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 | 415.20 titer |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 | 638.18 titer |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 | 250.56 titer |
Comparison: For Polio Type 1 the GMC ratio was calculated95% CI: [0.71, 1.09]
Comparison: For Polio Type 2 the GMC ratio was calculated95% CI: [0.66, 1.03]
Comparison: For Polio Type 3 the GMC ratio was calculated95% CI: [0.59, 1.02]
Comparison: For Polio Type 1 the GMC ratio was calculated95% CI: [0.72, 1.41]
Comparison: For Polio Type 2 the GMC ratio was calculated95% CI: [0.72, 1.34]
Comparison: For Polio Type 3 the GMC ratio was calculated95% CI: [0.6, 1.17]
Primary
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
Time frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group | 1.28 μg/mL |
| 7vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group | 1.40 μg/mL |
| 13vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group | 12.15 μg/mL |
| 7vPnC After the Toddler Dose | Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group | 11.68 μg/mL |
Comparison: For Hib (PRP) the GMC ratio was calculated95% CI: [0.73, 1.14]
Comparison: For Hib (PRP) the GMC ratio was calculated95% CI: [0.82, 1.32]
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Time frame: One month after the 3-Dose Infant Series (at 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; (n) = number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 18C (n=242) | 1.42 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 19F (n=241) | 1.55 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 4 (n=244) | 1.29 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 6B (n=241) | 0.74 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 9V (n=238) | 1.15 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 14 (n=236) | 2.74 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 23F (n=244) | 0.92 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 1 (n=240) | 1.21 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 3 (n=242) | 1.25 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 5 (n=243) | 0.93 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 6A (n=243) | 0.94 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 7F (n=238) | 1.93 μg/mL |
| 13vPnC After the Infant Series | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 19A (n=244) | 2.10 μg/mL |
Primary
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after the 3-Dose Infant Series (at 5 months of age)
Population: Evaluable immunogenicity (per protocol) population 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 immunoglobulin G (IgG) antibody concentration to the given serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 18C (n=242) | 90.5 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 19F (n=241) | 97.9 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 23F (n=244) | 82.8 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 1 (n=240) | 90.8 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 3 (n=242) | 96.3 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 5 (n=243) | 84.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 6A (n=243) | 85.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 7F (n=238) | 97.5 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Additional Serotypes - Serotype 19A (n=244) | 97.5 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 4 (n=244) | 91.4 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 6B (n=241) | 72.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 9V (n=238) | 92.9 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC | Common Serotypes - Serotype 14 (n=236) | 94.9 percentage of participants |
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Time frame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 (1:8) | 92.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.01 (IU/mL) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 1.0 (μg/mL) | 58.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.1 (IU/mL) | 84.9 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 0.15 (μg/mL) | 95.5 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥26 Toddler 17 (EU/mL) | 94.3 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 (1:8) | 88.8 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 (1:8) | 77.7 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.1 (IU/mL) | 76.5 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.01 (IU/mL) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL) | 93.5 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 (1:8) | 91.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.01 (IU/mL) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 0.15 (μg/mL) | 94.6 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.1 (IU/mL) | 82.2 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 1.0 (μg/mL) | 63.1 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥26 Toddler 17 (EU/mL) | 95.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 (1:8) | 93.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 (1:8) | 82.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL) | 95.8 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.1 (IU/mL) | 84.6 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.01 (IU/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥26 Toddler 17 (EU/mL) | 98.3 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL) | 92.5 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.1 (IU/mL) | 99.2 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.01 (IU/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.1 (IU/mL) | 96.2 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.01 (IU/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 (1:8) | 97.9 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 (1:8) | 98.7 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 (1:8) | 99.2 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 0.15 (μg/mL) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 1.0 (μg/mL) | 97.9 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL) | 95.5 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.01 (IU/mL) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥26 Toddler 17 (EU/mL) | 96.2 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 3 (1:8) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Pertussis - PT Infant ≥5 Toddler 5 (EU/mL) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 2 (1:8) | 99.2 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Tetanus 0.1 (IU/mL) | 98.5 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.01 (IU/mL) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Diphtheria 0.1 (IU/mL) | 100 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 1.0 (μg/mL) | 97.7 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Hib (PRP) 0.15 (μg/mL) | 100.0 percentage of participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group | Polio Type 1 (1:8) | 98.4 percentage of participants |
Comparison: For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated95% CI: [-4.8, 3.3]
Comparison: For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated95% CI: [-6.4, 1.7]
Comparison: For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated95% CI: [-1.7, 2.7]
Comparison: For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated95% CI: [-1.4, 6.8]
Comparison: For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated95% CI: [-1.7, 2.7]
Comparison: For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated95% CI: [-1.7, 2.7]
Comparison: For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated95% CI: [-8, 2.5]
Comparison: For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated95% CI: [-14.9, -1.2]
Comparison: For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated95% CI: [-1.4, 1.4]
Comparison: For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated95% CI: [-3.7, 9.2]
Comparison: For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated95% CI: [-1.5, 1.5]
Comparison: For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated95% CI: [-3.1, 1.8]
Comparison: For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated95% CI: [-1.7, 2.7]
Comparison: For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated95% CI: [-5.8, 1.8]
Comparison: For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated95% CI: [-1.7, 2.7]
Comparison: For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated95% CI: [-7.6, 3]
Comparison: For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated95% CI: [-11.4, 2.6]
Comparison: For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated95% CI: [-5, 4.3]
Comparison: For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated95% CI: [-3.6, 3.5]
Comparison: For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated95% CI: [-3.1, 3]
Comparison: For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated95% CI: [-3.1, 1.9]
Comparison: For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated95% CI: [-3.2, 5]
Comparison: For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated95% CI: [-13.2, 4.4]
Comparison: For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated95% CI: [-1.7, 2.8]
Comparison: For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated95% CI: [-3.1, 4.5]
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (Sev) (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 14.4 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 5.5 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 44.5 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 36.9 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 40.9 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 41.3 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 9.5 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 38.3 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 38.5 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 45.6 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 4.9 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 46.9 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 9.3 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 38.7 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 3.7 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 35.7 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 46.6 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 50.0 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 7.3 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 53.4 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 14.0 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 33.2 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 5.4 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 50.9 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 58.1 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 42.2 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 56.7 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 6.7 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 54.5 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 6.8 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 51.3 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 14.4 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 3.7 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 14.0 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 44.6 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 52.5 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 36.2 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 55.8 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 48.4 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 8.9 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 55.7 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 45.8 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 3.1 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 51.1 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 32.0 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 12.5 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 16.0 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 59.2 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 66.8 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 53.5 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 60.0 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 50.3 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 5.2 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 48.1 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 19.5 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.7 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 24.2 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.7 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 15.9 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 57.6 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 44.8 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 55.6 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 54.7 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 4.7 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 60.4 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 18.4 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=256,260,236,241,226,223,187,106,99) | 63.6 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild(n=249,255,223,232,213,214,181,99,95) | 57.9 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=254,256,226,235,217,219,185,99,97) | 59.8 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Sig (n=237,245,203,208,188,193,155,86,75) | 8.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=241,245,205,206,190,192,165,87,79) | 20.3 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tender-Any (n=256,257,223,225,210,206,189,96,89) | 64.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild(n=252,259,234,240,223,221,180,106,95) | 60.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Sev (n=235,244,199,203,184,188,152,87,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Sev (n=234,244,199,203,184,188,152,86,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=243,246,207,208,193,194,159,88,82) | 20.7 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 After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 54.4 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 34.5 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 0.8 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 34.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 24.7 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 29.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 28.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 13.5 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 32.8 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 52.5 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 41.3 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 10.0 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 0.4 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 34.6 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 20.6 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 23.1 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 19.8 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 18.5 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 28.4 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 36.7 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 26.5 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 48.3 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 1.0 Percentage of Participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 38.4 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 26.1 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 25.3 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 27.1 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 49.6 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 44.5 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 32.2 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 40.3 Percentage of Participants |
| 7vPnC After the Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 2.4 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 26.9 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 28.4 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 0.5 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.5 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 23.2 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 41.9 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 23.7 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 25.1 Percentage of Participants |
| 7vPnC/13vPnC Before Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 36.1 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 42.1 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 21.1 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 20.9 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 27.9 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 1.6 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 40.3 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 28.4 Percentage of Participants |
| 7vPnC/13vPnC After Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 37.6 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 50.6 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 38.7 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 21.5 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.7 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 26.2 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 47.8 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 4.6 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 36.8 Percentage of Participants |
| 13vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 29.3 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 22.6 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 23.9 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 34.4 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 54.0 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 46.5 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 41.4 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 2.2 Percentage of Participants |
| 7vPnC/7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 44.4 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73) | 4.1 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-prevent sx(n=252,260,221,236,201,213,181,99,85 | 40.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Incr sleep (n=256,259,215,227,194,204,163,92,81) | 23.5 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr appetite(n=243,251,211,218,194,199,167,96,83) | 31.3 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=261,265,232,238,217,211,178,99,91) | 50.5 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med-treat sx(n=248,259,224,227,202,214,180,100,89) | 55.1 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=238,245,200,205,184,190,153,88,73) | 0.0 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr sleep (n=246,253,,215,218,203,196,168,93,81) | 30.9 Percentage of Participants |
| 7vPnC/13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83) | 42.2 Percentage of Participants |
Secondary
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after the toddler dose (at 13 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 1 | 126.00 titer |
| 13vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 3 | 345.33 titer |
| 13vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 5 | 244.18 titer |
| 13vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 6A | 1346.83 titer |
| 13vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 7F | 8126.24 titer |
| 13vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 19A | 804.06 titer |
| 7vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 7F | 17034.59 titer |
| 7vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 1 | 61.58 titer |
| 7vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 6A | 891.44 titer |
| 7vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 3 | 428.88 titer |
| 7vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 19A | 1072.43 titer |
| 7vPnC After the Infant Series | Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose | Additional Serotypes - Serotype 5 | 130.99 titer |
Secondary
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after the toddler dose (at 13 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 1 | 100.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 3 | 100.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 5 | 100.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 6A | 100.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 7F | 100.0 Percentage of Participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 19A | 98.8 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 7F | 100.0 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 1 | 98.9 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 6A | 98.9 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 3 | 97.8 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 19A | 97.8 Percentage of Participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 5 | 97.8 Percentage of Participants |
Secondary
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after the toddler dose (at 13 months of age)
Population: Evaluable immunogenicity (per protocol) population 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 antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 9V (n=232,124,109) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 7F (n=234,124,110) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 3 (n=233,124,113) | 94.8 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 19F (n=233,126,112) | 97.9 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 18C (n=230,125,113) | 99.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 23F (n=232,123,111) | 99.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 1 (n=233,119,112) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 4 (n=233,126,111) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 14 (n=233,135,111) | 99.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 6A (n=235,124,109) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 6B (n=233,126,108) | 99.6 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 19A(n=233,127,112) | 100.0 percentage of participants |
| 13vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 5 (n=236,111,111) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 9V (n=232,124,109) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 14 (n=233,135,111) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 4 (n=233,126,111) | 100.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 6B (n=233,126,108) | 99.2 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 18C (n=230,125,113) | 99.2 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 19F (n=233,126,112) | 97.6 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 23F (n=232,123,111) | 99.2 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 1 (n=233,119,112) | 0.8 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 3 (n=233,124,113) | 13.7 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 5 (n=236,111,111) | 73.0 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 6A (n=235,124,109) | 89.5 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 7F (n=234,124,110) | 7.3 percentage of participants |
| 7vPnC After the Infant Series | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 19A(n=233,127,112) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 3 (n=233,124,113) | 93.8 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 6B (n=233,126,108) | 98.1 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 7F (n=234,124,110) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 5 (n=236,111,111) | 90.1 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 4 (n=233,126,111) | 99.1 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 9V (n=232,124,109) | 100.0 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 19F (n=233,126,112) | 97.3 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 6A (n=235,124,109) | 89.9 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 23F (n=232,123,111) | 99.1 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 14 (n=233,135,111) | 99.1 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 1 (n=233,119,112) | 95.5 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common Serotypes - Serotype 18C (n=230,125,113) | 98.2 percentage of participants |
| 13vPnC After the Toddler Dose | Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional Serotypes - Serotype 19A(n=233,127,112) | 100.0 percentage of participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-1.7, 2.9]
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-0.9, 4.9]
Comparison: For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-4.9, 2.1]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-1.8, 3.8]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-1.1, 5.9]
Comparison: For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-5.8, 2.7]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-1.7, 2.9]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-1.8, 3.3]
Comparison: For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-3.3, 3]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-2.5, 2.4]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-1.8, 4.4]
Comparison: For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-4.9, 2.1]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-1.8, 3.8]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-1.1, 5.7]
Comparison: For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-5.5, 2.8]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-3.1, 4.7]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-2.9, 5.4]
Comparison: For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-5.5, 4.4]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-1.8, 3.9]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated95% CI: [-1.9, 4.4]
Comparison: For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated95% CI: [-4.1, 3.7]
Secondary
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after the Toddler Dose (at 13 months of age)
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 23F (n=237,232,130,123,118,111) | 0.3 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 4 (n=239,233,131,126,118,111) | 0.3 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 3 (n=232,233,128,124,115,113) | 0.2 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 1 (n=239,233,128,119,116,112) | 0.4 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 19A(n=237,233,131,127,117,112) | 1.5 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 6B (n=235,233,131,126,115,108) | 1.0 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 7F (n=239,234,131,124,117,110) | 0.8 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 9V (n=239,232,131,124,118,109) | 0.4 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 14 (n=238,233,131,125,118,111) | 2.0 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 6A (n=238,235,122,124,116,109) | 0.9 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 18C (n=239,230,131,125,118,113) | 0.3 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 5 (n=236,236,128,124,115,113) | 0.8 μg/mL |
| 13vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 19F (n=239,233,130,126,118,112) | 0.7 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 23F (n=237,232,130,123,118,111) | 3.0 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 5 (n=236,236,128,124,115,113) | 3.3 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 9V (n=239,232,131,124,118,109) | 2.3 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 3 (n=232,233,128,124,115,113) | 1.0 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 6B (n=235,233,131,126,115,108) | 9.0 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 19F (n=239,233,130,126,118,112) | 5.2 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 1 (n=239,233,128,119,116,112) | 4.1 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 19A(n=237,233,131,127,117,112) | 9.5 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 4 (n=239,233,131,126,118,111) | 4.2 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 7F (n=239,234,131,124,117,110) | 4.5 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 14 (n=238,233,131,125,118,111) | 9.5 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 18C (n=239,230,131,125,118,113) | 2.3 μg/mL |
| 7vPnC After the Infant Series | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 6A (n=238,235,122,124,116,109) | 6.1 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 7F (n=239,234,131,124,117,110) | 0.1 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 6B (n=235,233,131,126,115,108) | 1.1 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 19A(n=237,233,131,127,117,112) | 1.1 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 9V (n=239,232,131,124,118,109) | 0.5 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 3 (n=232,233,128,124,115,113) | 0.1 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 14 (n=238,233,131,125,118,111) | 2.4 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 23F (n=237,232,130,123,118,111) | 0.3 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 6A (n=238,235,122,124,116,109) | 0.4 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 5 (n=236,236,128,124,115,113) | 0.4 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 1 (n=239,233,128,119,116,112) | 0.0 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 4 (n=239,233,131,126,118,111) | 0.5 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 19F (n=239,233,130,126,118,112) | 0.7 μg/mL |
| 13vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 18C (n=239,230,131,125,118,113) | 0.3 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 5 (n=236,236,128,124,115,113) | 0.5 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 19F (n=239,233,130,126,118,112) | 4.1 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 4 (n=239,233,131,126,118,111) | 4.8 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 6B (n=235,233,131,126,115,108) | 9.6 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 9V (n=239,232,131,124,118,109) | 3.2 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 14 (n=238,233,131,125,118,111) | 10.8 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 18C (n=239,230,131,125,118,113) | 2.8 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 23F (n=237,232,130,123,118,111) | 3.7 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 1 (n=239,233,128,119,116,112) | 0.0 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 3 (n=232,233,128,124,115,113) | 0.1 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 6A (n=238,235,122,124,116,109) | 1.5 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 7F (n=239,234,131,124,117,110) | 0.1 μg/mL |
| 7vPnC After the Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 19A(n=237,233,131,127,117,112) | 4.0 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 9V (n=239,232,131,124,118,109) | 0.4 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 5 (n=236,236,128,124,115,113) | 0.4 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 6B (n=235,233,131,126,115,108) | 0.9 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 18C (n=239,230,131,125,118,113) | 0.3 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 19A(n=237,233,131,127,117,112) | 0.9 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 7F (n=239,234,131,124,117,110) | 0.1 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 14 (n=238,233,131,125,118,111) | 2.4 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 4 (n=239,233,131,126,118,111) | 0.5 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 19F (n=239,233,130,126,118,112) | 0.6 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 1 (n=239,233,128,119,116,112) | 0.0 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 3 (n=232,233,128,124,115,113) | 0.1 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 6A (n=238,235,122,124,116,109) | 0.4 μg/mL |
| 7vPnC/13vPnC Before Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 23F (n=237,232,130,123,118,111) | 0.3 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 6A (n=238,235,122,124,116,109) | 2.6 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 9V (n=239,232,131,124,118,109) | 2.3 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 3 (n=232,233,128,124,115,113) | 1.3 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 18C (n=239,230,131,125,118,113) | 2.4 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 14 (n=238,233,131,125,118,111) | 7.8 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 5 (n=236,236,128,124,115,113) | 1.1 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 19A(n=237,233,131,127,117,112) | 5.3 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 19F (n=239,233,130,126,118,112) | 3.7 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 6B (n=235,233,131,126,115,108) | 10.3 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 4 (n=239,233,131,126,118,111) | 4.0 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 7F (n=239,234,131,124,117,110) | 3.7 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Additional-Serotype 1 (n=239,233,128,119,116,112) | 1.8 μg/mL |
| 7vPnC/13vPnC After Toddler Dose | Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups | Common - Serotype 23F (n=237,232,130,123,118,111) | 3.1 μg/mL |
Comparison: For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.73, 1.03]
Comparison: For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.67, 1.03]
Comparison: For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.86, 1.26]
Comparison: For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.77, 1.13]
Comparison: For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.82, 1.4]
Comparison: For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.69, 1.1]
Comparison: For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.68, 0.94]
Comparison: For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.59, 0.85]
Comparison: For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.95, 1.33]
Comparison: For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.73, 1.06]
Comparison: For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.58, 0.9]
Comparison: For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [1, 1.49]
Comparison: For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.69, 0.97]
Comparison: For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.69, 1.08]
Comparison: For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.78, 1.15]
Comparison: For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [1, 1.59]
Comparison: For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.68, 1.2]
Comparison: For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [1.08, 1.79]
Comparison: For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.67, 1]
Comparison: For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.67, 1.07]
Comparison: For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated95% CI: [0.78, 1.19]