Vaccines, Pneumococcal Conjugate Vaccine
Conditions
Keywords
Prevention against pneumococcal disease
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 Taiwan.
Interventions
13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 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
No
Inclusion criteria
* Healthy 2-month-old infants (42 to 98 days) * Available for the entire study period (14 months)
Exclusion criteria
* Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines * A previous anaphylactic reaction to any vaccine or vaccine-related component.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | 1 month after the infant series (7 months of age) | Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | 1 month after toddler dose (16 months of age) | Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Within 4 days after Dose 1 of the infant series (2 Months of Age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Within 4 Days after Dose 2 of the infant series (4 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Within 4 days after Dose 3 of the infant series (6 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Within 4 days after the toddler dose (15 months of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | 1 month after the 3-dose infant series (7 months of age) | Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Within 4 days after Dose 2 of the infant series (4 months of age) | Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Within 4 days after dose 3 of the infant series (6 months of age) | Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Within 4 days after the toddler dose (15 months of age) | Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Within 4 days after Dose 1 of the infant series (2 months of age) | Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | 1 month after the toddler dose (16 months of age) | Antibody GMC as measured in mcg/mL 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. |
Countries
Taiwan
Participant flow
Recruitment details
Subjects were recruited in Taiwan from June 2008 to Nov 2009
Pre-assignment details
A total of 169 subjects were screened, 168 subjects were randomly assigned in a 1:1 ratio to either the 13vPnC group (n=84) or the 7vPnC group (n=84).
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. | 84 |
| 7vPnC Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. | 84 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Infant Series | Parent or legal guardian request | 4 | 0 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age, Continuous | 2.2 months STANDARD_DEVIATION 0.3 | 2.3 months STANDARD_DEVIATION 0.3 | 2.2 months STANDARD_DEVIATION 0.3 |
| Region of Enrollment Taiwan, Province Of China | 84 Participants | 84 Participants | 168 Participants |
| Sex: Female, Male Female | 40 Participants | 47 Participants | 87 Participants |
| Sex: Female, Male Male | 44 Participants | 37 Participants | 81 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 | 81 / 83 | 77 / 84 | 11 / 83 | 16 / 84 | 39 / 80 | 47 / 84 |
| serious Total, serious adverse events | 4 / 83 | 4 / 84 | 12 / 83 | 9 / 84 | 0 / 80 | 3 / 84 |
Outcome results
Primary
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 9V | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 1 | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 18C | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 3 | 97.5 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 6B | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 5 | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 19F | 98.8 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 6A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 14 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 7F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 23F | 95.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 19A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 4 | 98.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 19A | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 6B | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 14 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 18C | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 19F | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Common Serotypes - Serotype 23F | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 1 | 2.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 3 | 2.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 5 | 61.5 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 6A | 77.1 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series. | Additional Serotypes - Serotype 7F | 2.4 percentage of participants |
Comparison: Common serotypes - serotype 495% CI: [-6.8, 3.3]Chan and Zhang
Comparison: Common serotypes - serotype 6B95% CI: [-4.6, 4.3]Chan and Zhang
Comparison: Common serotypes - serotype 9V95% CI: [-6.8, 3.3]Chan and Zhang
Comparison: Common serotypes - serotype 1495% CI: [-4.6, 4.3]Chan and Zhang
Comparison: Common serotypes - serotype 18C95% CI: [-4.6, 4.3]Chan and Zhang
Comparison: Common serotypes - serotype 19F95% CI: [-6.8, 3.3]Chan and Zhang
Comparison: Common serotypes - serotype 23F95% CI: [-12.3, -0.3]Chan and Zhang
Comparison: Additional serotypes - serotype 195% CI: [89.4, 99.2]Chan and Zhang
Comparison: Additional serotypes - serotype 395% CI: [87.7, 98.6]Chan and Zhang
Comparison: Additional serotypes - serotype 595% CI: [26.2, 48.9]Chan and Zhang
Comparison: Additional serotypes - serotype 6A95% CI: [14.4, 33.4]Chan and Zhang
Comparison: Additional serotypes - serotype 7F95% CI: [91.6, 99.7]Chan and Zhang
Comparison: Additional serotypes - serotype 19A95% CI: [-4.6, 4.5]Chan and Zhang
Secondary
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 month after toddler dose (16 months of age)
Population: Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 9V | 98.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 1 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 18C | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 3 | 96.2 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 6B | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 5 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 19F | 98.7 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 6A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 14 | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 7F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 23F | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 19A | 100.0 percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 4 | 98.7 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 19A | 98.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 4 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 6B | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 9V | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 14 | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 18C | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 19F | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Common Serotypes - Serotype 23F | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 1 | 5.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 3 | 13.8 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 5 | 90.4 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 6A | 100.0 percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose | Additional Serotypes - Serotype 7F | 6.3 percentage of participants |
Comparison: Common serotypes - serotype 495% CI: [-6.9, 3.1]Chan and Zhang
Comparison: Common serotypes - serotype 6B95% CI: [-4.6, 4.4]Chan and Zhang
Comparison: Common serotypes - serotype 9V95% CI: [-6.9, 3.1]Chan and Zhang
Comparison: Common serotypes - serotype 1495% CI: [-4.6, 4.4]Chan and Zhang
Comparison: Common serotypes - serotype 18C95% CI: [-4.6, 4.4]Chan and Zhang
Comparison: Common serotypes - serotype 19F95% CI: [-6.9, 3.1]Chan and Zhang
Comparison: Common serotypes - serotype 23F95% CI: [-4.6, 4.4]Chan and Zhang
Comparison: Additional serotypes - serotype 195% CI: [87.7, 98.6]Chan and Zhang
Comparison: Additional serotypes - serotype 395% CI: [72, 90.1]Chan and Zhang
Comparison: Additional serotypes - serotype 595% CI: [3.8, 18.1]Chan and Zhang
Comparison: Additional serotypes - serotype 6A95% CI: [-4.6, 4.4]Chan and Zhang
Comparison: Additional serotypes - serotype 7F95% CI: [86, 97.9]Chan and Zhang
Comparison: Additional serotypes - serotype 19A95% CI: [-3.4, 6.5]Chan and Zhang
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 month after the 3-dose infant series (7 months of age)
Population: Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 9V | 1.97 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 1 | 4.14 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 18C | 2.39 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 3 | 1.20 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 6B | 4.37 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 5 | 2.47 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 19F | 3.60 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 6A | 4.57 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 14 | 9.76 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 7F | 3.67 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 23F | 1.93 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 19A | 3.69 GMC mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 4 | 2.89 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 19A | 2.46 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 4 | 4.64 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 6B | 4.82 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 9V | 2.92 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 14 | 11.59 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 18C | 3.07 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 19F | 4.77 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Common serotypes - serotype 23F | 3.25 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 1 | 0.02 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 3 | 0.05 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 5 | 0.43 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 6A | 0.79 GMC mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series | Additional serotypes - serotype 7F | 0.04 GMC mcg/mL |
Comparison: Common serotypes - serotype 495% CI: [0.5, 0.78]
Comparison: Common serotypes - serotype 6B95% CI: [0.7, 1.17]
Comparison: Common serotypes - serotype 9V95% CI: [0.55, 0.82]
Comparison: Common serotypes - serotype 1495% CI: [0.67, 1.06]
Comparison: Common serotypes - serotype 18C95% CI: [0.63, 0.97]
Comparison: Common serotypes - serotype 19F95% CI: [0.6, 0.94]
Comparison: Common serotypes - serotype 23F95% CI: [0.46, 0.77]
Comparison: Additional serotypes - serotype 195% CI: [157.04, 261.32]
Comparison: Additional serotypes - serotype 395% CI: [18.46, 31.49]
Comparison: Additional serotypes - serotype 595% CI: [4.37, 7.41]
Comparison: Additional serotypes - serotype 6A95% CI: [4.42, 7.67]
Comparison: Additional serotypes - serotype 7F95% CI: [75.6, 122.17]
Comparison: Additional serotypes - serotype 19A95% CI: [1.23, 1.83]
Other Pre-specified
GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: 1 month after the toddler dose (16 months of age)
Population: Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 3.18 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 1 | 7.62 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 18C | 3.67 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 3 | 1.29 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 13.62 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 5 | 4.57 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 19F | 8.07 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 6A | 11.55 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 8.17 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 7F | 5.91 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 23F | 5.51 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 19A | 8.82 GMC mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 4.06 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 19A | 1.98 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 4 | 6.34 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 6B | 13.28 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 9V | 3.88 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 14 | 12.04 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 18C | 4.87 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 19F | 7.41 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 23F | 7.97 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 1 | 0.03 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 3 | 0.12 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 5 | 0.95 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 6A | 3.79 GMC mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 7F | 0.06 GMC mcg/mL |
Comparison: Common serotypes - serotype 495% CI: [0.49, 0.84]
Comparison: Common serotypes - serotype 6B95% CI: [0.77, 1.36]
Comparison: Common serotypes - serotype 9V95% CI: [0.64, 1.05]
Comparison: Common serotypes - serotype 1495% CI: [0.51, 0.91]
Comparison: Common serotypes - serotype 18C95% CI: [0.57, 0.99]
Comparison: Common serotypes - serotype 19F95% CI: [0.83, 1.43]
Comparison: Common serotypes - serotype 23F95% CI: [0.52, 0.92]
Comparison: Additional serotypes - serotype 195% CI: [213.63, 431.83]
Comparison: Additional serotypes - serotype 395% CI: [7.77, 14.62]
Comparison: Additional serotypes - serotype 595% CI: [3.78, 6.08]
Comparison: Additional serotypes - serotype 6A95% CI: [2.28, 4.08]
Comparison: Additional serotypes - serotype 7F95% CI: [75.6, 145.84]
Comparison: Additional serotypes - serotype 19A95% CI: [3.54, 5.6]
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 of the infant series (2 Months of Age)
Population: Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). number analyzed= number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Tenderness - Any | 31.3 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Tenderness - Significant | 5.3 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Any | 25.6 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Mild | 24.4 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Moderate | 1.4 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Any | 29.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Mild | 26.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Moderate | 8.1 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Mild | 26.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Tenderness - Any | 34.2 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Tenderness - Significant | 9.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Any | 11.8 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Any | 28.9 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Mild | 11.8 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Redness - Moderate | 2.7 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age). | Swelling - Moderate | 0.0 percentage of participants |
Comparison: For Tenderness - Any, Fisher exact test was used to calculate p-value.p-value: 0.735Fisher Exact
Comparison: For Tenderness - Significant, Fisher exact test was used to calculate p-value.p-value: 0.533Fisher Exact
Comparison: For Swelling - Any, Fisher exact test was used to calculate p-value.p-value: 0.039Fisher Exact
Comparison: For Swelling - Mild, Fisher exact test was used to calculate p-value.p-value: 0.059Fisher Exact
Comparison: For Swelling - Moderate, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Redness - Any, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Redness - Mild, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Redness - Moderate, Fisher exact test was used to calculate p-value.p-value: 0.275Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 of the infant series (4 months of age)
Population: Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness - Any | 23.6 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness - Significant | 2.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Any | 12.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Mild | 12.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Moderate | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Any | 17.1 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Mild | 17.1 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Moderate | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Mild | 17.6 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness - Any | 22.4 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Tenderness - Significant | 1.4 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Any | 15.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Any | 20.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Mild | 15.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Redness - Moderate | 2.8 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Swelling - Moderate | 0.0 percentage of participants |
Comparison: For Tenderness - Any, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Tenderness - Significant, Fisher exact test was used to calculate p-value.p-value: 0.617Fisher Exact
Comparison: For Swelling - Any, Fisher exact test was used to calculate p-value.p-value: 0.81Fisher Exact
Comparison: For Swelling - Mild, Fisher exact test was used to calculate p-value.p-value: 0.81Fisher Exact
Comparison: For Redness - Any, Fisher exact test was used to calculate p-value.p-value: 0.674Fisher Exact
Comparison: For Redness - Mild, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Redness - Moderate, Fisher exact test was used to calculate p-value.p-value: 0.497Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 of the infant series (6 months of age)
Population: Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness - Any | 19.4 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness - Significant | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Any | 16.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Mild | 15.4 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Moderate | 3.1 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Any | 20.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Mild | 18.2 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Moderate | 4.5 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Mild | 13.8 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness - Any | 17.9 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Tenderness - Significant | 1.5 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Any | 4.6 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Any | 13.8 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Mild | 4.6 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Redness - Moderate | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Swelling - Moderate | 0.0 percentage of participants |
Comparison: For Tenderness - Any, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Tenderness - Significant, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Swelling - Any, Fisher exact test was used to calculate p-value.p-value: 0.044Fisher Exact
Comparison: For Swelling - Mild, Fisher exact test was used to calculate p-value.p-value: 0.076Fisher Exact
Comparison: For Swelling - Moderate, Fisher exact test was used to calculate p-value.p-value: 0.496Fisher Exact
Comparison: For Redness - Any, Fisher exact test was used to calculate p-value.p-value: 0.361Fisher Exact
Comparison: For Redness - Mild, Fisher exact test was used to calculate p-value.p-value: 0.635Fisher Exact
Comparison: For Redness - Moderate, Fisher exact test was used to calculate p-value.p-value: 0.244Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 the toddler dose (15 months of age)
Population: Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Tenderness - Any | 10.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Tenderness - Significant | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Any | 7.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Mild | 6.3 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Moderate | 1.6 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Any | 15.4 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Mild | 13.8 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Moderate | 1.6 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Mild | 12.9 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Tenderness - Any | 22.7 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Tenderness - Significant | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Severe | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Any | 5.7 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Any | 12.9 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Mild | 5.7 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Redness - Moderate | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age). | Swelling - Moderate | 0.0 percentage of participants |
Comparison: For Tenderness - Any, Fisher exact test was used to calculate p-value.p-value: 0.076Fisher Exact
Comparison: For Swelling - Any, Fisher exact test was used to calculate p-value.p-value: 0.735Fisher Exact
Comparison: For Swelling - Mild, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Swelling - Moderate, Fisher exact test was used to calculate p-value.p-value: 0.477Fisher Exact
Comparison: For Redness - Any, Fisher exact test was used to calculate p-value.p-value: 0.805Fisher Exact
Comparison: For Redness - Mild, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Redness - Moderate, Fisher exact test was used to calculate p-value.p-value: 0.477Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after Dose 1 of the infant series (2 months of age)
Population: Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (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 With 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 With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability | 65.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >39 but <=40 degrees C | 1.4 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep | 53.2 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite | 50.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep | 44.3 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >=38 but <=39 degrees C | 55.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased sleep | 41.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >=38 but <=39 degrees C | 50.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Fever >39 but <=40 degrees C | 1.4 percentage of participants |
| 7vPnC | Percentage of Participants With 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 With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Decreased appetite | 55.6 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Irritability | 70.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Increased sleep | 50.6 percentage of participants |
Comparison: For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.p-value: 0.633Fisher Exact
Comparison: For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Decreased appetite, Fisher exact test was used to calculate p-value.p-value: 0.527Fisher Exact
Comparison: For Irritability, Fisher exact test was used to calculate p-value.p-value: 0.613Fisher Exact
Comparison: For Increased sleep, Fisher exact test was used to calculate p-value.p-value: 0.753Fisher Exact
Comparison: For Decreased sleep, Fisher exact test was used to calculate p-value.p-value: 0.748Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after Dose 2 of the infant series (4 months of age)
Population: Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With 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 With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability | 56.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >39 but <=40 degrees C | 2.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep | 41.1 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite | 50.7 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep | 42.3 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >=38 but <=39 degrees C | 52.1 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased sleep | 32.5 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >=38 but <=39 degrees C | 43.4 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Fever >39 but <=40 degrees C | 2.8 percentage of participants |
| 7vPnC | Percentage of Participants With 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 With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Decreased appetite | 56.1 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Irritability | 57.5 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Increased sleep | 43.4 percentage of participants |
Comparison: For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.p-value: 0.327Fisher Exact
Comparison: For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Decreased appetite, Fisher exact test was used to calculate p-value.p-value: 0.522Fisher Exact
Comparison: For Irritability, Fisher exact test was used to calculate p-value.p-value: 0.872Fisher Exact
Comparison: For Increased sleep, Fisher exact test was used to calculate p-value.p-value: 0.868Fisher Exact
Comparison: For Decreased sleep, Fisher exact test was used to calculate p-value.p-value: 0.237Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after dose 3 of the infant series (6 months of age)
Population: Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability | 42.6 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >39 but <=40 degrees C | 4.6 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep | 40.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite | 43.5 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep | 30.9 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >=38 but <=39 degrees C | 31.8 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased sleep | 33.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >=38 but <=39 degrees C | 22.7 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >39 but <=40 degrees C | 9.1 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Fever >40 degrees C | 1.6 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Decreased appetite | 52.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Irritability | 47.9 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Increased sleep | 37.1 percentage of participants |
Comparison: For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.p-value: 0.329Fisher Exact
Comparison: For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.p-value: 0.492Fisher Exact
Comparison: For Fever \>40 degrees C, Fisher exact test was used to calculate p-value.p-value: 0.496Fisher Exact
Comparison: For Decreased appetite, Fisher exact test was used to calculate p-value.p-value: 0.322Fisher Exact
Comparison: For Irritability, Fisher exact test was used to calculate p-value.p-value: 0.61Fisher Exact
Comparison: For Increased sleep, Fisher exact test was used to calculate p-value.p-value: 0.726Fisher Exact
Comparison: For Decreased sleep, Fisher exact test was used to calculate p-value.p-value: 0.855Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).
Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Within 4 days after the toddler dose (15 months of age)
Population: Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Fever >40 degrees C | 0.0 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Irritability | 27.7 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Fever >39 but <=40 degrees C | 3.2 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Increased sleep | 16.7 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Decreased appetite | 27.7 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Decreased sleep | 17.2 percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Fever >=38 but <=39 degrees C | 29.2 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Decreased sleep | 23.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Fever >=38 but <=39 degrees C | 21.4 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Fever >39 but <=40 degrees C | 4.3 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Fever >40 degrees C | 0.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Decreased appetite | 30.7 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Irritability | 27.0 percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age). | Increased sleep | 16.7 percentage of participants |
Comparison: For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.p-value: 0.326Fisher Exact
Comparison: For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Decreased appetite, Fisher exact test was used to calculate p-value.p-value: 0.714Fisher Exact
Comparison: For Irritability, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Increased sleep, Fisher exact test was used to calculate p-value.p-value: >0.99Fisher Exact
Comparison: For Decreased sleep, Fisher exact test was used to calculate p-value.p-value: 0.525Fisher Exact