Pneumococcal Vaccines
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 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
41 Days to 99 Days
Healthy volunteers
Yes
Inclusion criteria
1. Aged 2 months (42 to 98 days) at time of enrollment. 2. Available for entire study period and whose parent/legal guardian can be reached by telephone. 3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion criteria
1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines. 2. A previous anaphylactic reaction to any vaccine or vaccine-related component. 3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines. 4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 5. Known or suspected immune deficiency or suppression. 6. History of culture-proven invasive disease caused by S pneumoniae. 7. Major known congenital malformation or serious chronic disorders. 8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy. 9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). 10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable. 11. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | One month after 3-dose infant series (5 months of age) | Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Percentage of Participants Reporting Pre-Specified Local Reactions | During the 4-day period after each dose | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | During the 4-day period after each dose | Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | During the 4-day period after toddler dose | Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category. |
| Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | One month after 3-dose infant series (5 months of age) | Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
Countries
Poland
Participant flow
Recruitment details
Participants were recruited in Poland from June 2007 to August 2007.
Pre-assignment details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Manufacturing Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). | 135 |
| 13vPnC Pilot Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). | 134 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Withdrawal by Subject | 0 | 2 |
| Infant Series | Lost to Follow-up | 1 | 0 |
| Infant Series | Protocol Violation | 1 | 0 |
| Infant Series | Withdrawal by parent/guardian request | 2 | 1 |
| Toddler Dose | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | 13vPnC Manufacturing | 13vPnC Pilot | Total |
|---|---|---|---|
| Age Continuous | 2.1 months STANDARD_DEVIATION 0.6 | 2.1 months STANDARD_DEVIATION 0.5 | 2.1 months STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 65 Participants | 67 Participants | 132 Participants |
| Sex: Female, Male Male | 70 Participants | 67 Participants | 137 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 | 70 / 134 | 68 / 134 | 3 / 134 | 7 / 134 | 48 / 131 | 55 / 131 |
| serious Total, serious adverse events | 4 / 134 | 2 / 134 | 10 / 134 | 11 / 134 | 0 / 131 | 1 / 131 |
Outcome results
Primary
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after 3-dose infant series (5 months of age)
Population: Evaluable immunogenicity (per protocol) population were participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 1.28 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 1.42 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 1.60 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 1.20 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 0.80 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 0.96 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 1.60 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 0.87 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 2.15 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 2.00 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 0.82 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 2.19 μg/mL |
| 13vPnC Manufacturing | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 4 | 2.09 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A | 2.31 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 4 | 1.55 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B | 0.83 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V | 1.21 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 | 2.30 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C | 1.51 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F | 1.64 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F | 0.92 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 | 1.29 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 | 1.21 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 | 1.00 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A | 1.05 μg/mL |
| 13vPnC Pilot | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F | 2.14 μg/mL |
Comparison: For serotype 4 the GMC ratio was calculated95% CI: [1.1, 1.65]
Comparison: For serotype 6B the GMC ratio was calculated95% CI: [0.7, 1.31]
Comparison: For serotype 9V the GMC ratio was calculated95% CI: [0.89, 1.24]
Comparison: For serotype 14 the GMC ratio was calculated95% CI: [0.71, 1.22]
Comparison: For serotype 18C the GMC ratio was calculated95% CI: [0.86, 1.3]
Comparison: For serotype 19F the GMC ratio was calculated95% CI: [0.81, 1.17]
Comparison: For serotype 23F the GMC ratio was calculated95% CI: [0.7, 1.15]
Comparison: For serotype 1 the GMC ratio was calculated95% CI: [0.88, 1.37]
Comparison: For serotype 3 the GMC ratio was calculated95% CI: [0.83, 1.2]
Comparison: For serotype 5 the GMC ratio was calculated95% CI: [0.79, 1.16]
Comparison: For serotype 6A the GMC ratio was calculated95% CI: [0.66, 1.05]
Comparison: For serotype 7F the GMC ratio was calculated95% CI: [0.79, 1.11]
Comparison: For serotype 19A the GMC ratio was calculated95% CI: [0.79, 1.13]
Primary
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time frame: One month after 3-dose infant series (5 months of age)
Population: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 9V | 98.4 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 1 | 93.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 18C | 96.1 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 3 | 93.7 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 6B | 77.3 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 5 | 90.6 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 19F | 98.4 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 6A | 85.2 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 14 | 92.9 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 7F | 100.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 23F | 82.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 19A | 99.2 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 4 | 97.7 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 19A | 99.2 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 4 | 96.9 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 6B | 74.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 9V | 96.2 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 14 | 94.5 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 18C | 93.1 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 19F | 97.7 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Common Serotypes-Serotype 23F | 81.7 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 1 | 90.8 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 3 | 95.4 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 5 | 88.5 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 6A | 86.3 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Additional Serotypes-Serotype 7F | 100.0 percentage of participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-3.9, 5.6]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-7.3, 13.8]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-2.1, 7.3]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-8.2, 4.7]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-2.8, 9.2]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-3.5, 5.1]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-8.4, 10.6]
Comparison: For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-4.8, 9.2]
Comparison: For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-7.9, 4.2]
Comparison: For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-5.6, 9.9]
Comparison: For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-9.9, 7.6]
Comparison: For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-3, 2.8]
Comparison: For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated95% CI: [-3.6, 3.5]
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 6.1 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 22.7 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 0.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 0.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 18.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 28.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 28.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 25.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 20.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 17.7 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 7.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 24.4 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 1.6 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 20.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 22.9 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 3.9 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 1.6 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 20.3 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 30.2 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 29.5 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 8.6 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 37.2 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 36.4 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 3.1 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 8.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 1.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 33.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 25.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 17.2 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 33.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 27.1 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 3.1 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 1.6 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 40.0 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 8.9 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 27.0 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 15.3 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 5.6 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 29.4 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 38.4 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 25.6 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 13.3 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 34.1 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 33.3 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 12.6 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 3.4 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 30.3 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 8.8 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 33.9 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 24.3 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 1.8 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 10.6 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 22.1 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 37.4 percentage of participants |
| 13vPnC Manufacturing Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 22.1 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Severe(n=131,129,128,128,124,119,112,113) | 0.0 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mod (n=131,129,128,128,124,119,113,114) | 12.3 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mod (n=132,129,128,128,124,120,113,114) | 8.8 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Mild (n=132,131,129,131,125,123,115,115) | 36.5 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Any (n=132,130,129,129,126,122,113,115) | 26.1 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Severe(n=131,129,128,128,124,119,112,113) | 0.9 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=133,130,128,128,124,119,115,117) | 29.1 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness-Any (n=132,131,129,131,125,123,115,116) | 42.2 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig (n=131,129,128,128,124,119,112,114) | 3.5 percentage of participants |
| 13vPnC Pilot Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling-Mild (n=132,130,129,129,126,121,113,115) | 25.2 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to treat sx (n=132,130,128,128,124,123) | 12.9 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to prevent sx (n=132,130,128,129124,121) | 12.9 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased sleep (n=132,129,128,129124,121) | 41.7 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased sleep (n=132,130,129,129,124,123) | 27.3 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=134,131,130,131,127,123) | 50.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=131,129,128,128,124,119) | 0.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) | 18.2 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased appetite (n=133,129,129,128,125,121) | 20.3 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to prevent sx (n=132,130,128,129124,121) | 9.2 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased sleep (n=132,129,128,129124,121) | 39.5 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=131,129,128,128,124,119) | 0.8 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) | 19.2 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to treat sx (n=132,130,128,128,124,123) | 17.7 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased appetite (n=133,129,129,128,125,121) | 24.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased sleep (n=132,130,129,129,124,123) | 32.3 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=134,131,130,131,127,123) | 51.9 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=131,129,128,128,124,119) | 0.8 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased sleep (n=132,129,128,129124,121) | 25.0 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased appetite (n=133,129,129,128,125,121) | 14.7 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to treat sx (n=132,130,128,128,124,123) | 13.3 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to prevent sx (n=132,130,128,129124,121) | 11.7 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased sleep (n=132,130,129,129,124,123) | 24.0 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=134,131,130,131,127,123) | 53.8 percentage of participants |
| 13vPnC Manufacturing Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) | 16.3 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased sleep (n=132,129,128,129124,121) | 29.5 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) | 20.0 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=131,129,128,128,124,119) | 1.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased appetite (n=133,129,129,128,125,121) | 15.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=134,131,130,131,127,123) | 49.6 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased sleep (n=132,130,129,129,124,123) | 20.9 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to treat sx (n=132,130,128,128,124,123) | 14.1 percentage of participants |
| 13vPnC Pilot Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to prevent sx (n=132,130,128,129124,121) | 10.1 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=134,131,130,131,127,123) | 41.7 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased appetite (n=133,129,129,128,125,121) | 16.8 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased sleep (n=132,130,129,129,124,123) | 18.5 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to prevent sx (n=132,130,128,129124,121) | 10.5 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to treat sx (n=132,130,128,128,124,123) | 8.9 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) | 11.3 percentage of participants |
| 13vPnC Manufacturing Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased sleep (n=132,129,128,129124,121) | 20.2 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121) | 17.4 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased appetite (n=133,129,129,128,125,121) | 19.0 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Increased sleep (n=132,129,128,129124,121) | 30.6 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to prevent sx (n=132,130,128,129124,121) | 8.3 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Meds to treat sx (n=132,130,128,128,124,123) | 14.6 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Decreased sleep (n=132,130,129,129,124,123) | 19.5 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >40°C (n=131,129,128,128,124,119) | 0.0 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Irritability (n=134,131,130,131,127,123) | 37.4 percentage of participants |
| 13vPnC Pilot Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Fever >39°C but ≤40°C (n=131,129,128,128,124,119) | 3.4 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Time frame: During the 4-day period after toddler dose
Population: The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Irritability (n=119,123) | 40.3 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >40°C (n=112,113) | 0.0 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Increased sleep (n=114,119) | 18.4 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >39°C but ≤40°C (n=112,113) | 0.9 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased sleep (n=116,117) | 13.8 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to treat symptoms (n=113,115) | 17.7 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased appetite (n=115,117) | 20.9 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to prevent symptoms (n=114,114) | 12.3 percentage of participants |
| 13vPnC Manufacturing | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever ≥38°C but ≤39°C (n=114,114) | 14.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to prevent symptoms (n=114,114) | 12.3 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever ≥38°C but ≤39°C (n=114,114) | 13.2 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >39°C but ≤40°C (n=112,113) | 0.9 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Fever >40°C (n=112,113) | 0.0 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased appetite (n=115,117) | 23.1 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Irritability (n=119,123) | 44.7 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Increased sleep (n=114,119) | 16.8 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Medication to treat symptoms (n=113,115) | 17.4 percentage of participants |
| 13vPnC Pilot | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Decreased sleep (n=116,117) | 13.7 percentage of participants |