Pneumococcal Infections
Conditions
Keywords
Vaccines, Pneumococcal
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
1 dose at 6, 10, 14 weeks and 12 months of age
BIOLOGICAL7 valent pneumococcal conjugate vaccine
1 dose at 6, 10, 14 weeks and 12 months of age
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 72 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment 2. Available for the entire study period
Exclusion criteria
1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines 2. A previous anaphylactic reaction to any vaccine or vaccine-related component 3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
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 (18 weeks of age) | Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 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 19 A) are presented. |
| Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | 1 month after the infant series (18 weeks of age) | Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) 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 the toddler dose (13 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, 2-sided 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 19 A) are presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Within 4 days after the dose 2 of the infant series (10 weeks of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Within 4 days after the dose 3 of the infant series (14 weeks of age) | Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Within 4 days after the toddler dose (12 months of age) | Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | 1 month after the 3-dose infant series (18 weeks 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. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated. |
| Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Within 4 days after the dose 2 of the infant series (10 weeks 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. |
| Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Within 4 days after the dose 3 of the infant series (14 weeks 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. |
| Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Within 4 days after the toddler dose(12 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. |
| Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Within 4 days after the dose 1 of the infant series (6 weeks 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 IgG Antibody, 1 Month After the Toddler Dose | 1 month after toddler dose (13 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. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented. |
| Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Within 4 days after the dose 1 of the infant series (6 weeks of age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
Countries
India
Participant flow
Pre-assignment details
708 participants were enrolled and 709 were randomized into the study. One infant in the 13vPnC group was randomly assigned twice because of technical difficulties with the first random assignment. Though this infant participated in the study only once, both random assignments were included in the 354 participants in the 13vPnC group.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). | 354 |
| 7vPnC Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). | 355 |
| Total | 709 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 4 | 1 |
| After Infant Series | Failed to return | 1 | 0 |
| After Infant Series | Investigator request | 10 | 10 |
| After Infant Series | Lost to Follow-up | 4 | 0 |
| After Infant Series | Other reasons | 1 | 0 |
| After Infant Series | Parent/legal guardian request | 1 | 3 |
| Infant Series | Adverse Event | 1 | 2 |
| Infant Series | Clinical hold - consent withdrawn | 118 | 123 |
| Infant Series | Death | 0 | 1 |
| Infant Series | Failed to return | 4 | 1 |
| Infant Series | Investigator request | 0 | 1 |
| Infant Series | Lost to Follow-up | 2 | 2 |
| Infant Series | Other reasons | 1 | 2 |
| Infant Series | Parent/legal guardian request | 8 | 6 |
| Infant Series | Protocol Violation | 1 | 3 |
| Toddler Dose | Failed to return | 0 | 1 |
| Toddler Dose | Parent/legal guardian request | 0 | 1 |
Baseline characteristics
| Characteristic | Total | 7vPnC | 13vPnC |
|---|---|---|---|
| Age Continuous | 7.1 weeks STANDARD_DEVIATION 1.1 | 7.2 weeks STANDARD_DEVIATION 1.1 | 7.1 weeks STANDARD_DEVIATION 1.1 |
| Sex/Gender, Customized Female | 338 participants | 169 participants | 169 participants |
| Sex/Gender, Customized Male | 370 participants | 186 participants | 184 participants |
| Sex/Gender, Customized Unknown | 1 participants | 0 participants | 1 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 | 330 / 353 | 316 / 353 | 5 / 353 | 9 / 353 | 98 / 198 | 98 / 200 |
| serious Total, serious adverse events | 8 / 353 | 6 / 353 | 8 / 353 | 11 / 353 | 4 / 198 | 1 / 200 |
Outcome results
Primary
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
Time frame: 1 month after the infant series (18 weeks 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 for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | PT >=0.975 EU/mL | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | FHA >=3.91 EU/mL | 100.0 Percentage of participants |
| 13vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | PRN >=6 EU/mL | 92.7 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | PT >=0.975 EU/mL | 100.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | FHA >=3.91 EU/mL | 100.0 Percentage of participants |
| 7vPnC | Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. | PRN >=6 EU/mL | 95.9 Percentage of participants |
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 O'Brien-Fleming-adjusted, exact, 2-sided 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 19 A) are presented.
Time frame: 1 month after the infant series (18 weeks 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
| 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 (n= 204,195) | 92.6 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 (n= 206,195) | 96.6 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 (n= 204,188) | 95.1 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 (n= 201,187) | 87.6 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 (n= 196,194) | 84.7 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 (n= 201,185) | 85.1 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 (n= 200,188) | 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 6A (n= 200,191) | 90.0 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 (n= 185,186) | 91.4 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 (n= 203,192) | 98.0 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 (n= 202,186) | 90.1 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 19 A (n= 204,190) | 99.5 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 4 (n= 203, 192) | 97.0 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 19 A (n= 204,190) | 84.7 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 (n= 203, 192) | 97.9 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 (n= 196,194) | 87.1 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. | Common serotypes - serotype 9V (n= 204,195) | 94.4 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. | Common serotypes - serotype 14 (n= 185,186) | 93.5 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. | Common serotypes - serotype 18C (n= 204,188) | 93.1 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. | Common serotypes - serotype 19F (n= 200,188) | 94.7 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 (n= 202,186) | 89.2 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 (n= 206,195) | 0.5 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 3 (n= 201,187) | 2.1 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 5 (n= 201,185) | 24.3 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 (n= 200,191) | 36.1 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 (n= 203,192) | 2.6 Percentage of participants |
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, 2-sided 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 19 A) are presented.
Time frame: 1 month after the toddler dose (13 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
| 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 14 (n= 193,196) | 99.5 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 (n= 193,196) | 98.4 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 (n= 193, 196) | 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 (n= 193,196) | 90.2 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 18C (n= 193,196) | 99.5 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 (n= 192,196) | 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 9V (n= 193,196) | 99.5 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 (n= 193,196) | 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 (n= 193,196) | 97.9 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 (n= 193,196) | 99.0 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 6B (n= 192,195) | 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 19 A (n= 193,196) | 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 (n= 193,196) | 98.4 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 19 A (n= 193,196) | 98.5 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 (n= 193, 196) | 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 (n= 192,195) | 99.5 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 (n= 193,196) | 99.5 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 (n= 193,196) | 99.5 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 (n= 193,196) | 99.0 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 (n= 193,196) | 98.0 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 (n= 193,196) | 99.5 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 (n= 193,196) | 3.1 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 (n= 193,196) | 12.9 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 (n= 192,196) | 74.3 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 (n= 193,196) | 92.8 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 7F (n= 193,196) | 9.8 Percentage of participants |
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose 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. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
Time frame: 1 month after the 3-dose infant series (18 weeks 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 9V (n= 204,195) | 1.34 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 23F (n= 202,186) | 1.38 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 7F (n= 203,195) | 2.27 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 1 (n= 206,195) | 1.95 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 14 (n= 185,186) | 2.84 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 3 (n= 201,195) | 0.80 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 6B (n= 196,194) | 1.45 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 5 (n= 201,195) | 0.93 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 18C (n= 204,188) | 1.61 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 6A (n= 200,195) | 1.44 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 4 (n= 203,192) | 2.19 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 19A (n= 204,195) | 2.76 mcg/mL |
| 13vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 19F (n= 200,188) | 2.25 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 19A (n= 204,195) | 0.74 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 4 (n= 203,192) | 2.58 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 6B (n= 196,194) | 1.56 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 9V (n= 204,195) | 1.46 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 14 (n= 185,186) | 2.39 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 18C (n= 204,188) | 1.70 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 19F (n= 200,188) | 2.47 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Common serotypes - serotype 23F (n= 202,186) | 1.46 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 1 (n= 206,195) | 0.03 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 3 (n= 201,195) | 0.05 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 5 (n= 201,195) | 0.20 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 7F (n= 203,195) | 0.06 mcg/mL |
| 7vPnC | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series | Additional serotypes - serotype 6A (n= 200,195) | 0.28 mcg/mL |
Other Pre-specified
GMC for Serotype-specific Pneumococcal 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. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.
Time frame: 1 month after toddler dose (13 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. n=number of participants with determinate IgG antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n= 193,196) | 3.01 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n= 193,196) | 5.10 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n= 193,196) | 2.63 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n= 193,196) | 0.91 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n= 192, 195) | 12.24 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n= 192,196) | 3.58 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n= 193,196) | 8.38 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n= 193,196) | 8.13 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n= 193,196) | 10.59 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n= 193,196) | 4.81 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n= 193,196) | 4.27 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 19A (n= 193,196) | 14.12 mcg/mL |
| 13vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n= 193, 196) | 5.33 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 19A (n= 193,196) | 3.56 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 4 (n= 193, 196) | 5.85 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 6B (n= 192, 195) | 11.60 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 9V (n= 193,196) | 3.33 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 14 (n= 193,196) | 10.95 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 18C (n= 193,196) | 2.98 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 19F (n= 193,196) | 5.65 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Common serotypes - serotype 23F (n= 193,196) | 5.31 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 1 (n= 193,196) | 0.04 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 3 (n= 193,196) | 0.09 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 5 (n= 192,196) | 0.64 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 6A (n= 193,196) | 1.87 mcg/mL |
| 7vPnC | GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose | Additional serotypes - serotype 7F (n= 193,196) | 0.06 mcg/mL |
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after the dose 1 of the infant series (6 weeks of age)
Population: Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks 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 1 (6 Weeks of Age) | Induration: Mild (n= 338,340) | 19.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Any (n= 333,339) | 12.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Any (n= 339,342) | 21.5 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Mild (n= 333,338) | 11.4 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Moderate (n= 331,338) | 4.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Moderate (n= 330,337) | 1.5 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Tenderness: Significant (n= 341,343) | 42.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Severe (n= 329,336) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Severe (n= 329,336) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Any of the above (n= 349,348) | 66.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Tenderness: Any (n= 347,347) | 62.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Any of the above (n= 349,348) | 65.2 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Tenderness: Any (n= 347,347) | 59.7 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Tenderness: Significant (n= 341,343) | 40.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Any (n= 339,342) | 22.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Mild (n= 338,340) | 19.1 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Moderate (n= 331,338) | 5.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Induration: Severe (n= 329,336) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Any (n= 333,339) | 13.3 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Mild (n= 333,338) | 11.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Moderate (n= 330,337) | 1.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age) | Erythema: Severe (n= 329,336) | 0.0 Percentage of participants |
Comparison: Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.483Fisher Exact
Comparison: Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.698Fisher Exact
Comparison: Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.782Fisher Exact
Comparison: Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.729Fisher Exact
Comparison: Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.819Fisher Exact
Comparison: Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.904Fisher Exact
Comparison: Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.69Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after the dose 2 of the infant series (10 weeks of age)
Population: Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks 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 (10 Weeks of Age) | Induration: Mild (n= 281,277) | 16.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Any (n= 275,280) | 13.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Any (n= 281,278) | 20.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Mild (n= 275,279) | 13.1 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Moderate (n= 273,272) | 5.1 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Moderate (n= 273,273) | 1.5 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Tenderness: Significant (n= 278,279) | 26.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Severe (n= 273,271) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Severe (n= 273,271) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Any of the above (n= 285,286) | 51.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Tenderness: Any (n= 284,282) | 44.4 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Any of the above (n= 285,286) | 53.1 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Tenderness: Any (n= 284,282) | 44.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Tenderness: Significant (n= 278,279) | 28.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Any (n= 281,278) | 18.7 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Mild (n= 281,277) | 16.2 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Moderate (n= 273,272) | 4.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Induration: Severe (n= 273,271) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Any (n= 275,280) | 17.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Mild (n= 275,279) | 15.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Moderate (n= 273,273) | 2.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age) | Erythema: Severe (n= 273,271) | 0.0 Percentage of participants |
Comparison: Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.933Fisher Exact
Comparison: Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.776Fisher Exact
Comparison: Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.596Fisher Exact
Comparison: Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.909Fisher Exact
Comparison: Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.683Fisher Exact
Comparison: Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.203Fisher Exact
Comparison: Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.399Fisher Exact
Comparison: Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.382Fisher Exact
Comparison: Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.738Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after the dose 3 of the infant series (14 weeks of age)
Population: Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks 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 (14 Weeks of Age) | Induration: Mild (n= 196,195) | 15.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Any (n= 192,195) | 10.4 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Any (n= 198,195) | 17.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Mild (n= 192,195) | 10.4 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Moderate (n= 193,193) | 2.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Moderate (n= 191,193) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Tenderness: Significant (n= 199,196) | 24.1 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Severe (n= 191,193) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Severe (n= 191,193) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Any of the above (n= 206,202) | 43.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Tenderness: Any (n= 204,200) | 37.3 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Any of the above (n= 206,202) | 42.1 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Tenderness: Any (n= 204,200) | 38.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Tenderness: Significant (n= 199,196) | 23.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Any (n= 198,195) | 13.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Mild (n= 196,195) | 11.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Moderate (n= 193,193) | 3.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Induration: Severe (n= 191,193) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Any (n= 192,195) | 9.7 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Mild (n= 192,195) | 9.2 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Moderate (n= 191,193) | 0.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age) | Erythema: Severe (n= 191,193) | 0.0 Percentage of participants |
Comparison: Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.918Fisher Exact
Comparison: Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.906Fisher Exact
Comparison: Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.404Fisher Exact
Comparison: Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.305Fisher Exact
Comparison: Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.771Fisher Exact
Comparison: Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.867Fisher Exact
Comparison: Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.735Fisher Exact
Comparison: Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.842Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 4 days after the toddler dose (12 months of age)
Population: Safety population: all participants who received toddler dose vaccination(after 12 months). 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 (12 Months of Age) | Induration: Mild (n= 170,175) | 15.9 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Any (n= 174,176) | 14.9 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Any (n= 173,176) | 19.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Mild (n= 172,175) | 12.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Moderate (n= 170,171) | 5.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Moderate (n= 169,170) | 3.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant (n= 171,170) | 15.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Severe (n= 167,169) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Severe (n= 167,169) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Any of the above (n= 177,178) | 36.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any (n= 174,176) | 29.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Any of the above (n= 177,178) | 41.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Any (n= 174,176) | 30.7 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Tenderness: Significant (n= 171,170) | 17.1 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Any (n= 173,176) | 17.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Mild (n= 170,175) | 14.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Moderate (n= 170,171) | 7.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Induration: Severe (n= 167,169) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Any (n= 174,176) | 14.2 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Mild (n= 172,175) | 10.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Moderate (n= 169,170) | 4.1 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Erythema: Severe (n= 167,169) | 0.0 Percentage of participants |
Comparison: Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.908Fisher Exact
Comparison: Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.772Fisher Exact
Comparison: Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.681Fisher Exact
Comparison: Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.881Fisher Exact
Comparison: Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.509Fisher Exact
Comparison: Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.88Fisher Exact
Comparison: Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.739Fisher Exact
Comparison: Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.446Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks 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 the dose 1 of the infant series (6 weeks of age)
Population: Safety population: all participants who received at least dose 1 of the infant series vaccination (after 6 weeks. 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 1 (6 Weeks of Age) | Fever >=38 but <=39 degrees C (n= 313,324) | 19.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Fever >39 but <=40 degrees C (n= 309,322) | 2.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Fever >40 degrees C (n= 309,322) | 0.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Decreased appetite (n= 343,347) | 55.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Irritability (n= 345,347) | 83.2 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Increased sleep (n= 338,342) | 40.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Decreased sleep (n= 336,343) | 55.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Any systemic event (n= 350,348) | 94.3 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Any systemic event (n= 350,348) | 90.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Fever >=38 but <=39 degrees C (n= 313,324) | 21.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Irritability (n= 345,347) | 79.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Fever >39 but <=40 degrees C (n= 309,322) | 1.2 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Decreased sleep (n= 336,343) | 56.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Fever >40 degrees C (n= 309,322) | 0.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Increased sleep (n= 338,342) | 36.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age) | Decreased appetite (n= 343,347) | 55.9 Percentage of participants |
Comparison: Difference in incidence rates of fever \>=38 but \<=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.625Fisher Exact
Comparison: Difference in incidence rates of fever \>39 but \<=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.375Fisher Exact
Comparison: Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.624Fisher Exact
Comparison: Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.282Fisher Exact
Comparison: Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.307Fisher Exact
Comparison: Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.939Fisher Exact
Comparison: Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.085Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks 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 the dose 2 of the infant series (10 weeks of age)
Population: Safety population: all participants who received dose 2 of the infant series vaccination (10 weeks 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 (10 Weeks of Age) | Fever >=38 but <=39 degrees C (n= 263,249) | 10.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Fever >39 but <=40 degrees C (n= 259,247) | 0.8 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Fever >40 degrees C (n= 259,247) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Decreased appetite (n= 281,282) | 48.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Irritability (n= 290,291) | 70.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Increased sleep (n= 285,275) | 33.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Decreased sleep (n= 282,286) | 37.9 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Any systemic event (n= 294,297) | 80.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Any systemic event (n= 294,297) | 80.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Fever >=38 but <=39 degrees C (n= 263,249) | 15.3 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Irritability (n= 290,291) | 69.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Fever >39 but <=40 degrees C (n= 259,247) | 0.4 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Decreased sleep (n= 282,286) | 46.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Fever >40 degrees C (n= 259,247) | 0.4 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Increased sleep (n= 285,275) | 26.9 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age) | Decreased appetite (n= 281,282) | 46.5 Percentage of participants |
Comparison: Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.111Fisher Exact
Comparison: Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.488Fisher Exact
Comparison: Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.736Fisher Exact
Comparison: Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.856Fisher Exact
Comparison: Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.098Fisher Exact
Comparison: Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.034Fisher Exact
Comparison: Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks 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 the dose 3 of the infant series (14 weeks of age)
Population: Safety population: all participants who received dose 3 of the infant series vaccination (14 weeks 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 (14 Weeks of Age) | Fever >=38 but <=39 degrees C (n= 181,172) | 7.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Fever >39 but <=40 degrees C (n= 179,170) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Fever >40 degrees C (n= 179,171) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Decreased appetite (n= 202,200) | 42.1 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Irritability (n= 208,208) | 64.4 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Increased sleep (n= 199,195) | 20.1 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Decreased sleep (n= 205,201) | 42.4 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Any systemic event (n= 213,209) | 75.1 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Any systemic event (n= 213,209) | 78.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Fever >=38 but <=39 degrees C (n= 181,172) | 14.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Irritability (n= 208,208) | 67.3 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Fever >39 but <=40 degrees C (n= 179,170) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Decreased sleep (n= 205,201) | 36.8 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Fever >40 degrees C (n= 179,171) | 0.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Increased sleep (n= 199,195) | 20.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age) | Decreased appetite (n= 202,200) | 41.0 Percentage of participants |
Comparison: Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.085Fisher Exact
Comparison: Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.489Fisher Exact
Comparison: Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.84Fisher Exact
Comparison: Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.605Fisher Exact
Comparison: Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.265Fisher Exact
Comparison: Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.422Fisher Exact
Other Pre-specified
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 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 the toddler dose(12 months of age)
Population: Safety population: all participants who received toddler dose vaccination (12 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 (12 Months of Age) | Fever >=38 but <=39 degrees C (n= 161,154) | 5.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability (n= 174,183) | 38.5 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >40 degrees C (n= 160,152) | 0.0 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep (n= 171,170) | 12.3 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >39 but <=40 degrees (n= 160,152) | 0.6 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite (n= 174,179) | 28.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Any systemic event (n= 179,186) | 54.7 Percentage of participants |
| 13vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep (n= 172,178) | 22.7 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Any systemic event (n= 179,186) | 52.7 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >=38 but <=39 degrees C (n= 161,154) | 6.5 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >39 but <=40 degrees (n= 160,152) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Fever >40 degrees C (n= 160,152) | 0.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased appetite (n= 174,179) | 24.6 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Irritability (n= 174,183) | 35.0 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Increased sleep (n= 171,170) | 9.4 Percentage of participants |
| 7vPnC | Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Decreased sleep (n= 172,178) | 27.0 Percentage of participants |
Comparison: Difference in incidence rates of fever \>= 38 but \<= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.815Fisher Exact
Comparison: Difference in incidence rates of fever \>39 but \<= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: >0.99Fisher Exact
Comparison: Difference in incidence rates of fever \>40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.Fisher Exact
Comparison: Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.401Fisher Exact
Comparison: Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.511Fisher Exact
Comparison: Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.487Fisher Exact
Comparison: Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.388Fisher Exact
Comparison: Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.p-value: 0.753Fisher Exact