Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Keywords
Pneumococcal conjugate vaccine
Brief summary
The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
28 Days to 54 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 1 month old infants * Available for the duration of the study and reachable by telephone * Able to complete two blood drawing procedures during the study
Exclusion criteria
* Previous vaccination, contraindication or history of allergic reaction to vaccine or vaccine components * Bleeding disorder, immune deficiency or significant chronic or congenital disease * Previous receipt of blood products or immune globulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 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% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | 1 month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], and pertactin \[PRN\]) are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | 1 month after the toddler dose (13 months of age) | Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], and pertactin \[PRN\]) are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 (\> 7.0 cm). 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 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 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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-specified 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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-specified 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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
Countries
Brazil
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). | 163 |
| 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). | 162 |
| Total | 325 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 0 | 1 |
| After Infant Series | Failed to return | 1 | 1 |
| After Infant Series | Protocol Violation | 0 | 1 |
| Infant Series | Adverse Event | 2 | 3 |
| Infant Series | Died prior to receiving 7vPnC | 0 | 1 |
| Infant Series | Failed to return | 1 | 3 |
| Infant Series | Lost to Follow-up | 1 | 0 |
| Infant Series | Parent or legal guardian request | 10 | 8 |
| Infant Series | Protocol Violation | 6 | 3 |
| Toddler Dose | Failed to return | 2 | 0 |
| Toddler Dose | Parent or legal guardian request | 1 | 0 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 2.2 months STANDARD_DEVIATION 0.2 | 2.2 months STANDARD_DEVIATION 0.2 | 2.2 months STANDARD_DEVIATION 0.2 |
| Sex: Female, Male Female | 89 Participants | 76 Participants | 165 Participants |
| Sex: Female, Male Male | 74 Participants | 86 Participants | 160 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 | 140 / 163 | 140 / 162 | 18 / 163 | 12 / 162 | 84 / 155 | 86 / 156 |
| serious Total, serious adverse events | 10 / 163 | 10 / 162 | 10 / 163 | 5 / 162 | 2 / 155 | 3 / 156 |
Outcome results
Primary
Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], and pertactin \[PRN\]) are presented.
Time frame: 1 month after the infant series (7 months of age)
Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | PT ≥5 EU/mL | 35.9 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | FHA ≥5 EU/mL | 70.1 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | PRN ≥5 EU/mL | 93.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | PT ≥5 EU/mL | 32.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | FHA ≥5 EU/mL | 71.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | PRN ≥5 EU/mL | 96.2 percentage of participants |
Primary
Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 Month after the infant series (7 Months of age)
Population: Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 9V | 98.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 1 | 99.4 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 18C | 97.4 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 3 | 87.1 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 6B | 96.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 5 | 98.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 19F | 94.2 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 6A | 97.4 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 14 | 98.1 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 7F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 23F | 96.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 19A | 99.4 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 19A | 98.7 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 6B | 95.6 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 14 | 97.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 18C | 98.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 19F | 98.7 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Common serotypes - serotype 23F | 93.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 1 | 2.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 3 | 4.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 5 | 38.2 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 6A | 52.6 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Additional serotypes - serotype 7F | 1.3 percentage of participants |
Secondary
Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], and pertactin \[PRN\]) are presented.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | PT ≥5 EU/mL | 50.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | FHA ≥5 EU/mL | 91.4 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | PRN ≥5 EU/mL | 99.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | PT ≥5 EU/mL | 49.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | FHA ≥5 EU/mL | 88.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | PRN ≥5 EU/mL | 98.7 percentage of participants |
Secondary
Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 month after the toddler dose (13 months of age)
Population: Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 19F | 99.3 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 1 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 97.4 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 3 | 92.1 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 18C | 99.3 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 5 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 6A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 7F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 23F | 98.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 19A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 19A | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 99.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 98.7 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 18C | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 19F | 98.7 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Common serotypes - serotype 23F | 99.3 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 1 | 2.7 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 3 | 7.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 5 | 72.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 6A | 92.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Additional serotypes - serotype 7F | 4.2 percentage of participants |
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 (\> 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 study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any | 60.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant | 14.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Any | 13.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Mild | 10.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Moderate | 5.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Any | 10.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Mild | 8.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Moderate | 2.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Mild | 11.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Any | 59.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Tenderness: Significant | 12.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Any | 15.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Any | 13.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Mild | 13.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Redness: Moderate | 2.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Swelling: Moderate | 1.4 percentage of participants |
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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 2 (4 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any | 53.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant | 9.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Any | 12.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Mild | 10.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Moderate | 2.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Any | 9.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Mild | 9.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Moderate | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Mild | 11.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Any | 53.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness: Significant | 11.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Any | 13.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Any | 12.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Mild | 10.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness: Moderate | 1.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling: Moderate | 3.9 percentage of participants |
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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 3 (6 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any | 48.1 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant | 10.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Any | 14.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Mild | 12.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Moderate | 4.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Any | 10.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Mild | 10.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Moderate | 0.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Mild | 13.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Any | 47.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness: Significant | 8.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Any | 9.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Any | 14.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Mild | 9.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness: Moderate | 0.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling: Moderate | 0.9 percentage of participants |
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 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after toddler dose (12 months of age)
Population: Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any | 64.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Any | 13.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Any | 11.5 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Mild | 12.4 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Moderate | 5.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Moderate | 0.9 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) | Redness: Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant | 18.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any | 53.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant | 13.3 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Any | 10.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Moderate | 3.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Any | 8.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Mild | 7.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Redness: Moderate | 1.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Swelling: Mild | 8.7 percentage of participants |
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 population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability | 80.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >39 but ≤40 degrees C | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep | 56.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite | 26.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep | 39.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 but ≤39 degrees C | 18.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep | 27.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever ≥38 but ≤39 degrees C | 19.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >39 but ≤40 degrees C | 0.7 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >40 degrees C | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite | 28.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability | 77.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep | 52.4 percentage of participants |
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 population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >39 but ≤40 degrees C | 3.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite | 33.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 but ≤39 degrees C | 23.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep | 32.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep | 25.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability | 80.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep | 36.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability | 79.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever ≥38 but ≤39 degrees C | 23.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >39 but ≤40 degrees C | 0.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >40 degrees C | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite | 29.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep | 38.7 percentage of participants |
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 population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C | 0.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability | 76.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >39 but ≤40 degrees C | 4.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep | 35.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite | 37.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep | 27.6 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 but ≤39 degrees C | 22.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep | 34.1 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever ≥38 but ≤39 degrees C | 22.4 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >39 but ≤40 degrees C | 3.5 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C | 0.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite | 32.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability | 71.2 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep | 36.9 percentage of participants |
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 population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >40 degrees C | 0.9 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability | 67.2 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >39 but ≤40 degrees C | 1.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep | 30.8 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite | 33.3 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep | 22.7 percentage of participants |
| 13vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever ≥38 but ≤39 degrees C | 31.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep | 20.6 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever ≥38 but ≤39 degrees C | 29.9 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >39 but ≤40 degrees C | 3.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >40 degrees C | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite | 39.0 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability | 68.8 percentage of participants |
| 7vPnC | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep | 24.1 percentage of participants |