Pneumococcal Vaccine
Conditions
Keywords
Prevention, against, pneumococcal, disease, Vaccine
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
BIOLOGICAL7-valent pneumococcal conjugate vaccine
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2-month-old-infants (42 to 98 days) * Available for the entire study period (14 months)
Exclusion criteria
* Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine * A previous severe reaction to any vaccine or vaccine-related component
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 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 was calculated 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). Exact 2-sided CI was based on the observed percentage 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 (2 months of age) | Pre-specified 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 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). 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 (4 months of age) | Pre-specified 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 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 Local Reactions: Infant Series Dose 3 (6 Months of Age) | Within 4 days after dose 3 (6 months of age) | Pre-specified 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 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 Local Reactions: Toddler Dose (12 Months of Age) | Within 4 days after toddler dose (12 months of age) | Pre-specified 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 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. |
| Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (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 (4 months of age) | Pre-specified 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 (6 months of age) | Pre-specified 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) | Pre-specified 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 (2 months of age) | Pre-specified 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. |
| Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | 1 month after the Toddler Dose (13 months of age) | Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw. |
Countries
South Korea
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). | 91 |
| 7vPnC 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). | 89 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Parent/legal guardian request | 1 | 0 |
| Infant Series of Dosing | Adverse Event | 1 | 0 |
| Infant Series of Dosing | Lost to Follow-up | 0 | 1 |
| Infant Series of Dosing | Parent/legal guardian request | 5 | 0 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.1 months STANDARD_DEVIATION 0.3 | 2.1 months STANDARD_DEVIATION 0.2 | 2.1 months STANDARD_DEVIATION 0.2 |
| Sex: Female, Male Female | 45 Participants | 39 Participants | 84 Participants |
| Sex: Female, Male Male | 46 Participants | 50 Participants | 96 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 78 / 88 | 75 / 89 | 18 / 88 | 19 / 89 | 28 / 84 | 36 / 88 |
| serious Total, serious adverse events | 8 / 88 | 9 / 89 | 9 / 88 | 12 / 89 | 3 / 84 | 3 / 88 |
Outcome results
Primary
Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 23F | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 9V | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 1 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 6B | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 3 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 5 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 14 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 6A | 97.6 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 18C | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 7F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 19F | 97.6 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 19A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 19A | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 14 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 18C | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 19F | 98.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 23F | 98.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 1 | 2.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 3 | 2.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 5 | 57.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 6A | 72.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 7F | 4.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series | Serotype 6B | 100.0 percentage of participants |
Secondary
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, 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 a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 23F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 9V | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 19A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 14 | 98.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 3 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 18C | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 4 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 19F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 6A | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 1 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 5 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 7F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 6B | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 7F | 23.6 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 1 | 1.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 3 | 12.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 5 | 92.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 6A | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 19A | 98.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 6B | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 14 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 18C | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 23F | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose | Serotype 19F | 100.0 percentage of participants |
Other Pre-specified
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable Infant Immunogenicity Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 19A | 5.94 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 19F | 3.88 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 23F | 4.29 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 1 | 7.44 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 3 | 1.60 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 5 | 5.06 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 4 | 5.40 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 6B | 5.71 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 14 | 14.83 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 18C | 4.57 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 6A | 5.73 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 7F | 6.97 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 9V | 3.33 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 6A | 0.64 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 9V | 3.78 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 18C | 4.73 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 4 | 6.97 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 19F | 4.20 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 5 | 0.39 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 23F | 4.11 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 6B | 4.88 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 1 | 0.02 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 7F | 0.04 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 3 | 0.04 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 14 | 16.29 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series | Serotype 19A | 2.65 Mcg/mL |
Comparison: Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.62, 0.97]Student t distribution
Comparison: Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.87, 1.57]Student t distribution
Comparison: Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.73, 1.07]Student t distribution
Comparison: Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.7, 1.19]Student t distribution
Comparison: Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.79, 1.18]Student t distribution
Comparison: Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.71, 1.19]Student t distribution
Comparison: Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.8, 1.36]Student t distribution
Comparison: Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [242.98, 446.67]Student t distribution
Comparison: Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [30.27, 54.97]Student t distribution
Comparison: Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [9.92, 17.34]Student t distribution
Comparison: Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [6.46, 12.56]Student t distribution
Comparison: Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [122.95, 223.85]Student t distribution
Comparison: Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [1.83, 2.75]Student t distribution
Other Pre-specified
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.
Time frame: 1 month after the Toddler Dose (13 months of age)
Population: Evaluable Toddler Immunogenicity Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 19F | 7.75 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 6A | 13.58 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 9V | 4.59 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 6B | 16.81 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 18C | 6.86 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 1 | 9.29 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 23F | 10.95 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 3 | 1.65 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 14 | 11.51 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 7F | 11.17 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 5 | 8.92 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 19A | 10.12 Mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 4 | 6.46 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 19A | 2.38 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 4 | 8.25 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 6B | 15.14 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 9V | 4.83 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 14 | 15.64 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 18C | 7.44 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 19F | 5.35 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 23F | 10.44 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 5 | 1.31 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 6A | 3.33 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 1 | 0.04 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 3 | 0.10 Mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose | Serotype 7F | 0.10 Mcg/mL |
Comparison: Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.6, 1.02]Student t distribution
Comparison: Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.83, 1.48]Student t distribution
Comparison: Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.76, 1.19]Student t distribution
Comparison: Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.57, 0.95]Student t distribution
Comparison: Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.72, 1.19]Student t distribution
Comparison: Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [1.11, 1.88]Student t distribution
Comparison: Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [0.78, 1.4]Student t distribution
Comparison: Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [176.33, 311.41]Student t distribution
Comparison: Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [12.19, 22.69]Student t distribution
Comparison: Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [5.39, 8.67]Student t distribution
Comparison: Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [3.07, 5.43]Student t distribution
Comparison: Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [77.09, 159.59]Student t distribution
Comparison: Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)95% CI: [3.39, 5.33]Student t distribution
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Pre-specified 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 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 1 (2 months of age)
Population: Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any (n=23,26) | 31.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant (n=6,2) | 8.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Any (n=14,18) | 19.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Mild (n=8,18) | 11.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Any (n=27,22) | 37.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Mild (n=23,19) | 32.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Moderate (n=7,4) | 10.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Moderate (n=4,3) | 5.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Moderate (n=7,4) | 5.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any (n=23,26) | 34.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Any (n=27,22) | 29.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant (n=6,2) | 2.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Mild (n=23,19) | 25.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Any (n=14,18) | 24.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Moderate (n=4,3) | 4.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Mild (n=8,18) | 24.7 percentage of participants |
Comparison: Comparison between treatments for any tenderness.p-value: 0.862Fisher Exact
Comparison: Comparison between treatments for significant tenderness.p-value: 0.157Fisher Exact
Comparison: Comparison between treatments for any swelling.p-value: 0.55Fisher Exact
Comparison: Comparison between treatments for mild swelling.p-value: 0.052Fisher Exact
Comparison: Comparison between treatments for moderate swelling.p-value: 0.366Fisher Exact
Comparison: Comparison between treatments for any redness.p-value: 0.301Fisher Exact
Comparison: Comparison between treatments for mild redness.p-value: 0.362Fisher Exact
Comparison: Comparison between treatments for moderate redness.p-value: 0.718Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Pre-specified 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 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 4 days after dose 2 (4 months of age)
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any (n=23,24) | 38.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Moderate (n=4,4) | 7.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Mild (n=18,24) | 29.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant (n=0,3) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Any (n=22,18) | 35.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Mild (n=18,15) | 29.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Any (n=20,25) | 32.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Moderate (n=4,3) | 7.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant (n=0,3) | 5.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Mild (n=18,15) | 24.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Moderate (n=4,4) | 6.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Any (n=20,25) | 38.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Any (n=22,18) | 28.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Moderate (n=4,3) | 5.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any (n=23,24) | 37.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Mild (n=18,24) | 36.9 percentage of participants |
Comparison: Comparison between treatments for any tenderness.p-value: >0.99Fisher Exact
Comparison: Comparison between treatments for significant tenderness.p-value: 0.245Fisher Exact
Comparison: Comparison between treatments for any swelling.p-value: 0.447Fisher Exact
Comparison: Comparison between treatments for mild swelling.p-value: 0.684Fisher Exact
Comparison: Comparison between treatments for moderate swelling.p-value: >0.99Fisher Exact
Comparison: Comparison between treatments for any redness.p-value: 0.578Fisher Exact
Comparison: Comparison between treatments for mild redness.p-value: 0.451Fisher Exact
Comparison: Comparison between treatments for moderate redness.p-value: 0.712Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Pre-specified 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 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 4 days after dose 3 (6 months of age)
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any (n=15,16) | 23.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant (n=0,1) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Any (n=18,14) | 27.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Mild (n=13,13) | 21.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Any (n=19,16) | 30.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Mild (n=12,15) | 20.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Moderate (n=7,3) | 11.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Moderate (n=7,4) | 11.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Moderate (n=7,4) | 7.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any (n=15,16) | 27.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Mild (n=12,15) | 25.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant (n=0,1) | 1.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Any (n=19,16) | 26.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Any (n=18,14) | 23.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Moderate (n=7,3) | 5.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Mild (n=13,13) | 22.0 percentage of participants |
Comparison: Comparison between treatments for any tenderness.p-value: 0.681Fisher Exact
Comparison: Comparison between treatments for significant tenderness.p-value: 0.482Fisher Exact
Comparison: Comparison between treatments for any swelling.p-value: 0.683Fisher Exact
Comparison: Comparison between treatments for mild swelling.p-value: >0.99Fisher Exact
Comparison: Comparison between treatments for moderate swelling.p-value: 0.533Fisher Exact
Comparison: Comparison between treatments for any redness.p-value: 0.692Fisher Exact
Comparison: Comparison between treatments for mild redness.p-value: 0.662Fisher Exact
Comparison: Comparison between treatments for moderate redness.p-value: 0.331Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Pre-specified 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 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 4 days after toddler dose (12 months of age)
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant (n=3,1) | 5.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Severe (n=1,0) | 2.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Mild (n=4,7) | 8.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Any (n=15,12) | 28.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Any (n=11,10) | 22.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Mild (n=9,10) | 17.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Moderate (n=9,4) | 18.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Moderate (n=8,3) | 16.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any (n=19,14) | 33.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Moderate (n=8,3) | 6.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any (n=19,14) | 25.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant (n=3,1) | 2.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Any (n=11,10) | 18.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Mild (n=4,7) | 13.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Moderate (n=9,4) | 7.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Severe (n=1,0) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Any (n=15,12) | 22.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Mild (n=9,10) | 18.5 percentage of participants |
Comparison: Comparison between treatments for any tenderness.p-value: 0.409Fisher Exact
Comparison: Comparison between treatments for significant tenderness.p-value: 0.617Fisher Exact
Comparison: Comparison between treatments for any swelling.p-value: 0.807Fisher Exact
Comparison: Comparison between treatments for mild swelling.p-value: 0.527Fisher Exact
Comparison: Comparison between treatments for moderate swelling.p-value: 0.144Fisher Exact
Comparison: Comparison between treatments for severe swelling.p-value: 0.495Fisher Exact
Comparison: Comparison between treatments for any redness.p-value: 0.506Fisher Exact
Comparison: Comparison between treatments for mild redness.p-value: >0.99Fisher Exact
Comparison: Comparison between treatments for moderate redness.p-value: 0.2Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Pre-specified 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 (2 months of age)
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite (n=23,22) | 32.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep (n=37,30) | 49.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability (n=38,56) | 49.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep (n=28,38) | 37.8 percentage of participants |
| 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 (n=11,9) | 15.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep (n=28,38) | 50.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=11,9) | 12.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite (n=23,22) | 28.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability (n=38,56) | 70.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep (n=37,30) | 39.0 percentage of participants |
Comparison: Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.p-value: 0.633Fisher Exact
Comparison: Comparison between treatments for decreased appetite.p-value: 0.721Fisher Exact
Comparison: Comparison between treatments for irritability.p-value: 0.009Fisher Exact
Comparison: Comparison between treatments for increased sleep.p-value: 0.253Fisher Exact
Comparison: Comparison between treatments for decreased sleep.p-value: 0.143Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Pre-specified 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 (4 months of age)
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the 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 (n=6,8) | 10.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep (n=17,16) | 28.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability (n=25,36) | 40.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep (n=18,27) | 30.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite (n=16,28) | 27.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep (n=18,27) | 40.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=6,8) | 13.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite (n=16,28) | 44.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability (n=25,36) | 53.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep (n=17,16) | 26.2 percentage of participants |
Comparison: Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.p-value: 0.781Fisher Exact
Comparison: Comparison between treatments for decreased appetite.p-value: 0.06Fisher Exact
Comparison: Comparison between treatments for irritability.p-value: 0.159Fisher Exact
Comparison: Comparison between treatments for increased sleep.p-value: 0.839Fisher Exact
Comparison: Comparison between treatments for decreased sleep.p-value: 0.264Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Pre-specified 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 (6 months of age)
Population: Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the 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 (n=8,5) | 13.6 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 (n=0,1) | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite (n=14,16) | 23.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability (n=13,25) | 21.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep (n=18,12) | 29.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep (n=10,17) | 16.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite (n=14,16) | 28.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=8,5) | 9.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep (n=10,17) | 29.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep (n=18,12) | 21.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >39 degrees C but ≤40 degrees C (n=0,1) | 2.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability (n=13,25) | 41.7 percentage of participants |
Comparison: Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.p-value: 0.563Fisher Exact
Comparison: Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.p-value: 0.468Fisher Exact
Comparison: Comparison between treatments for decreased appetite.p-value: 0.535Fisher Exact
Comparison: Comparison between treatments for irritability.p-value: 0.019Fisher Exact
Comparison: Comparison between treatments for increased sleep.p-value: 0.398Fisher Exact
Comparison: Comparison between treatments for decreased sleep.p-value: 0.125Fisher Exact
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Pre-specified 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; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the 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 (n=7,10) | 13.7 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 (n=1,0) | 2.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite (n=13,15) | 22.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability (n=18,21) | 30.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep (n=11,8) | 21.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep (n=11,20) | 20.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep (n=11,8) | 15.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever ≥38 degrees C but ≤39 degrees C (n=7,10) | 19.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability (n=18,21) | 37.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >39 degrees C but ≤40 degrees C (n=1,0) | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep (n=11,20) | 34.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite (n=13,15) | 27.8 percentage of participants |
Comparison: Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.p-value: 0.596Fisher Exact
Comparison: Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.p-value: >0.99Fisher Exact
Comparison: Comparison between treatments for decreased appetite.p-value: 0.663Fisher Exact
Comparison: Comparison between treatments for irritability.p-value: 0.439Fisher Exact
Comparison: Comparison between treatments for increased sleep.p-value: 0.613Fisher Exact
Comparison: Comparison between treatments for decreased sleep.p-value: 0.138Fisher Exact