Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
Interventions
BIOLOGICAL13vPnC
First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2 to 6 month-old infant * Available for entire study period
Exclusion criteria
* Previous vaccination with licensed or investigational pneumococcal vaccine. * Previous anaphylactic reaction to any vaccine or vaccine-related component. * Contraindication to vaccination with a pneumococcal conjugate vaccine. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection. * Known or suspected immune deficiency or suppression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | one month after 3-dose infant series (at 7 months of age) | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | one mone month after 3-dose infant series (at 7 months of age) | GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | one month after the toddler dose (at 12 - 15 months of age) | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | one month after the toddler dose (at 12-15 months of age) | GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions | Within 7 days after each dose | Local reactions were collected using an electronic diary. Tenderness 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 (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events | Within 7 days after each dose | Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. |
Countries
Japan
Participant flow
Recruitment details
Participants were recruited in Japan from September 2007 to February 2008.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose). | 193 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| After Infant Series | Adverse Event | 2 |
| After Infant Series | Withdrawal by Subject | 1 |
| Infant Series | Adverse Event | 1 |
| Infant Series | Protocol Violation | 2 |
| Infant Series | Withdrawal by Subject | 2 |
| Toddler Dose | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | 13vPnC |
|---|---|
| Age Continuous | 3.7 months STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 192 / 193 | 19 / 193 | 171 / 185 |
| serious Total, serious adverse events | 9 / 193 | 14 / 193 | 1 / 185 |
Outcome results
Primary
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: one month after 3-dose infant series (at 7 months of age)
Population: Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 98.3 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 97.2 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 97.7 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 100.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 100.0 percentage of participants |
Secondary
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: one mone month after 3-dose infant series (at 7 months of age)
Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 4 | 6.76 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 4.77 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 3.39 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 14.69 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 3.68 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 5.71 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 2.57 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 5.11 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 2.87 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 3.85 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 3.77 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 5.78 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 6.97 μg/mL |
Secondary
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: one month after the toddler dose (at 12-15 months of age)
Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 14 | 16.33 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 4 | 9.70 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 6B | 14.61 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 9V | 4.49 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 18C | 6.09 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 19F | 12.20 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Common Serotypes - Serotype 23F | 6.55 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 1 | 9.85 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 3 | 2.06 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 5 | 7.31 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 6A | 11.03 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 7F | 8.31 μg/mL |
| 13vPnC After Infant Series | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | Additional Serotypes - Serotype 19A | 15.97 μg/mL |
Secondary
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: one month after the toddler dose (at 12 - 15 months of age)
Population: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F | 98.9 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F | 98.9 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 | 99.4 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F | 100 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A | 100 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (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 (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 7 days after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=165,156,147,143) | 13.3 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant (n=160,152,143,132) | 0.6 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=176,173,165,163) | 47.2 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=174,171,163,154) | 46.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=167,164,150,151) | 14.4 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=160,153,143,132) | 0.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=186,180,171,166) | 74.2 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=183,179,162,156) | 68.3 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=170,168,157,155) | 24.7 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=160,153,143,132) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=176,173,165,163) | 53.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=170,168,157,155) | 43.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=174,171,163,154) | 49.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=167,164,150,151) | 28.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=160,153,143,132) | 1.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=186,180,171,166) | 74.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=160,153,143,132) | 1.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=183,179,162,156) | 64.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=165,156,147,143) | 19.9 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=183,179,162,156) | 55.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=186,180,171,166) | 67.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=160,153,143,132) | 0.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=165,156,147,143) | 14.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=174,171,163,154) | 50.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=160,153,143,132) | 0.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=170,168,157,155) | 38.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=167,164,150,151) | 29.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=176,173,165,163) | 53.9 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate (n=167,164,150,151) | 36.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild (n=183,179,162,156) | 53.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe (n=160,153,143,132) | 2.3 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe (n=160,153,143,132) | 1.5 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any (n=186,180,171,166) | 68.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any (n=176,173,165,163) | 57.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild (n=174,171,163,154) | 44.2 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any (n=165,156,147,143) | 18.2 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate (n=170,168,157,155) | 40.6 percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 7 days after each dose
Population: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥37.5°C (n=170,163,154,150) | 32.9 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=169,160,145,138) | 21.3 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=163,156,146,137) | 6.7 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=175,160,153,139) | 40.6 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=163,158,144,138) | 11.7 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=161,153,143,133) | 1.2 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to prevent symptoms (n=160,153,144,134) | 0.6 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to treat symptoms (n=160,153,145,135) | 1.9 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=170,166,149,140) | 30.6 percentage of participants |
| 13vPnC After Infant Series | Percentage of Participants Reporting Pre-Specified Systemic Events | Hives (n=160,152,143,132) | 1.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=170,166,149,140) | 36.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Hives (n=160,152,143,132) | 1.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=175,160,153,139) | 29.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=169,160,145,138) | 23.1 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=161,153,143,133) | 2.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to prevent symptoms (n=160,153,144,134) | 3.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=160,152,143,132) | 0.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to treat symptoms (n=160,153,145,135) | 6.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=163,158,144,138) | 16.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=163,156,146,137) | 12.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥37.5°C (n=170,163,154,150) | 33.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to treat symptoms (n=160,153,145,135) | 5.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥37.5°C (n=170,163,154,150) | 40.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=163,156,146,137) | 10.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=161,153,143,133) | 2.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=163,158,144,138) | 9.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=170,166,149,140) | 23.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=175,160,153,139) | 22.2 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=169,160,145,138) | 15.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Hives (n=160,152,143,132) | 0.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to prevent symptoms (n=160,153,144,134) | 2.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=170,166,149,140) | 26.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to prevent symptoms (n=160,153,144,134) | 3.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Hives (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite (n=163,158,144,138) | 18.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C (n=160,152,143,132) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C (n=161,153,143,133) | 5.3 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Medication to treat symptoms (n=160,153,145,135) | 8.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C (n=163,156,146,137) | 20.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥37.5°C (n=170,163,154,150) | 50.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep (n=169,160,145,138) | 12.3 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep (n=175,160,153,139) | 24.5 percentage of participants |