Vaccines, Pneumococcal
Conditions
Brief summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
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
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone * Able to complete three blood draws during study * At least 3.5 kg at enrollment
Exclusion criteria
* Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines * Immune deficiency, bleeding disorder or significant chronic medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | 1 month after dose 2 of the infant series (5 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Within 4 days after dose 1 of Infant Series (2 months of age) | Local reactions were reported 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 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than \[\>\] 7.0cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Within 4 days after dose 2 of Infant Series (4 months of age) | Local reactions were reported 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Within 4 days after dose 3 (6 months of age) | Local reactions were reported 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Within 4 days after toddler dose (12 months of age) | Local reactions were reported 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Dose 2 of infant series (4 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% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Within 4 days after dose 2 of Infant Series (4 months of age) | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Within 4 days after dose 3 of Infant Series (6 months of age) | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Within 4 days after toddler dose (12 months of age) | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Within 4 days after dose 1 of Infant Series (2 months of age) | Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Dose 3 of infant series (6 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 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. |
| GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Toddler Dose (12 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 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) | 225 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| After Infant Series | Parent/Legal Guardian Request | 1 |
| Infant Series | Adverse Event | 1 |
| Infant Series | Failed to return | 2 |
| Infant Series | Lost to Follow-up | 4 |
| Infant Series | Other | 19 |
| Infant Series | Parent/legal guardian request | 6 |
| Infant Series | Protocol Violation | 1 |
| Toddler Dose | Failed to Return | 4 |
| Toddler Dose | Lost to Follow-up | 3 |
| Toddler Dose | Parent/Legal Guardian Request | 1 |
Baseline characteristics
| Characteristic | 13vPnC |
|---|---|
| Age Continuous | 2.1 months STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 116 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 | 182 / 223 | 3 / 223 | 96 / 191 |
| serious Total, serious adverse events | 3 / 223 | 3 / 223 | 2 / 191 |
Outcome results
Primary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 6B | 97.7 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 9V | 98.2 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 14 | 98.8 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 18C | 98.8 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 19F | 98.2 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Common serotypes - serotype 23F | 92.9 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Additional serotypes - serotype 1 | 99.4 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Additional serotypes - serotype 3 | 94.1 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Additional serotypes - serotype 5 | 98.2 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Additional serotypes - serotype 6A | 98.8 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Additional serotypes - serotype 7F | 98.8 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Additional serotypes - serotype 19A | 99.4 Percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 99.4 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 18C | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 19F | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Common serotypes - serotype 23F | 99.4 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Additional serotypes - serotype 1 | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Additional serotypes - serotype 3 | 96.7 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Additional serotypes - serotype 5 | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Additional serotypes - serotype 6A | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Additional serotypes - serotype 7F | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Additional serotypes - serotype 19A | 100.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after dose 2 of the infant series (5 months of age)
Population: Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 4 | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 6B | 80.9 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 9V | 95.9 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 14 | 99.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 18C | 93.3 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 19F | 98.5 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Common serotypes - serotype 23F | 77.9 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Additional serotypes - serotype 1 | 98.5 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Additional serotypes - serotype 3 | 96.4 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Additional serotypes - serotype 5 | 97.4 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Additional serotypes - serotype 6A | 94.9 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Additional serotypes - serotype 7F | 99.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Additional serotypes - serotype 19A | 99.5 Percentage of participants |
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series
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% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Time frame: Dose 2 of infant series (4 months of age)
Population: Evaluable 2-Dose Infant Immunogenicity population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 4 | 3.54 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 6B | 0.84 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 9V | 1.82 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 14 | 5.54 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 18C | 1.80 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 19F | 4.14 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Common serotypes - serotype 23F | 0.84 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Additional serotypes - serotype 1 | 3.41 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Additional serotypes - serotype 3 | 1.11 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Additional serotypes - serotype 5 | 1.89 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Additional serotypes - serotype 6A | 1.86 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Additional serotypes - serotype 7F | 2.98 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | Additional serotypes - serotype 19A | 3.52 mcg/mL |
Other Pre-specified
GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Time frame: Dose 3 of infant series (6 months of age)
Population: Evaluable 3-Dose Infant Immunogenicity population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 4 | 3.48 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 6B | 5.02 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 9V | 2.34 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 14 | 9.35 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 18C | 2.50 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 19F | 3.75 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Common serotypes - serotype 23F | 1.83 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Additional serotypes - serotype 1 | 4.23 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Additional serotypes - serotype 3 | 1.17 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Additional serotypes - serotype 5 | 3.11 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Additional serotypes - serotype 6A | 4.08 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Additional serotypes - serotype 7F | 3.71 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Additional serotypes - serotype 19A | 4.19 mcg/mL |
Other Pre-specified
GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.
Time frame: Toddler Dose (12 months of age)
Population: Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 4 | 5.10 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 6B | 15.41 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 9V | 3.76 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 14 | 10.62 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 18C | 3.93 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 19F | 11.33 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Common serotypes - serotype 23F | 5.70 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Additional serotypes - serotype 1 | 5.86 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Additional serotypes - serotype 3 | 1.62 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Additional serotypes - serotype 5 | 4.75 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Additional serotypes - serotype 6A | 11.64 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Additional serotypes - serotype 7F | 5.81 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose | Additional serotypes - serotype 19A | 8.95 mcg/mL |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Local reactions were reported 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 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than \[\>\] 7.0cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 1 of Infant Series (2 months of age)
Population: Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any | 63.5 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant | 12.4 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Any | 31.2 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Mild | 25.1 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Moderate | 11.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Severe | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Any | 33.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Mild | 27.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Moderate | 10.6 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Severe | 0 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Local reactions were reported 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 2 of Infant Series (4 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any | 69.4 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant | 12.6 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Any | 29.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Mild | 20.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Moderate | 13.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Severe | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Any | 28.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Mild | 19.5 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Moderate | 12.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Severe | 0 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Local reactions were reported 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 3 (6 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any | 61.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant | 15.4 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Any | 29.4 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Mild | 19.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Moderate | 14.6 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Severe | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Any | 31.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Mild | 20.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Moderate | 13.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Severe | 0 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Local reactions were reported 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (\>7.0cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after toddler dose (12 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any | 43.7 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant | 3.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Any | 21.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Mild | 8.1 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Moderate | 15.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Severe | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Any | 22.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Mild | 8.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Moderate | 15.7 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Severe | 0 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 1 of Infant Series (2 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C | 7.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >39 degrees C but ≤40 degrees C | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite | 31.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability | 69.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep | 37.2 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep | 32.8 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 2 of Infant Series (4 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C | 18.5 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >39 degrees C but ≤40 degrees C | 0.6 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite | 29.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability | 62.2 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep | 24.5 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep | 35.1 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 3 of Infant Series (6 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C | 18.3 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >39 degrees C but ≤40 degrees C | 2.2 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite | 25.7 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability | 63.2 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep | 22.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep | 37.3 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after toddler dose (12 months of age)
Population: Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C | 23.0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >39 degrees C but ≤40 degrees C | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >40 degrees C | 0 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite | 33.8 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability | 46.7 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep | 17.9 Percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep | 22.0 Percentage of participants |