Pneumococcal Infections
Conditions
Keywords
Pneumococcal Vaccines
Brief summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.
Interventions
BIOLOGICAL13-valent Pneumococcal Conjugate Vaccine
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged from 7 months to \<72 months at time of enrollment. 2. Available for entire study period and whose parent/legal guardian could be reached by telephone. 3. Healthy as determined by medical history, physical examination, and judgment of the investigator. 4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.
Exclusion criteria
1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. A previous anaphylactic reaction to any vaccine or vaccine-related component. 3. Contraindication to vaccination with pneumococcal vaccine. 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 monoclonal antibodies) in the last 3 months. 10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable. 11. Child 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 After Vaccination | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). | Percentages of participants achieving World Health Organization (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. |
| Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions | During the 4-day period after each dose | Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events | During the 4-day period after each dose | Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. |
Countries
Poland
Participant flow
Recruitment details
Participants were recruited in Poland from July 2007 to September 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 7 to <12 Months of Age Participants 7 to less than (\<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. | 90 |
| 13vPnC 12 to <24 Months of Age Participants 12 to \< 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. | 112 |
| 13vPnC 24 to < 72 Months of Age Participants 24 to \< 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC. | 153 |
| Total | 355 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 13vPnC 7 to <12 Months of Age | 13vPnC 12 to <24 Months of Age | 13vPnC 24 to < 72 Months of Age | Total |
|---|---|---|---|---|
| Age Continuous | 8.7 months STANDARD_DEVIATION 1.6 | 17.6 months STANDARD_DEVIATION 3.5 | 42.0 months STANDARD_DEVIATION 13.1 | 25.9 months STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 47 Participants | 58 Participants | 74 Participants | 179 Participants |
| Sex: Female, Male Male | 43 Participants | 54 Participants | 79 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 55 / 90 | 77 / 112 | 74 / 152 |
| serious Total, serious adverse events | 5 / 90 | 2 / 112 | 2 / 152 |
Outcome results
Primary
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
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: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects 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 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 19A | 4.77 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 4 | 3.63 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 6B | 4.77 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 9V | 2.56 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 14 | 8.04 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 18C | 2.77 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 19F | 2.88 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 23F | 2.16 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 1 | 2.88 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 3 | 1.94 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 5 | 2.85 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 6A | 3.72 μg/mL |
| 13vPnC 7 to <12 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 7F | 5.30 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 19A | 4.94 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 18C | 3.71 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 6A | 2.62 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 19F | 3.07 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 23F | 1.98 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 1 | 2.74 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 7F | 5.99 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 3 | 1.86 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 4 | 4.28 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 6B | 3.38 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 5 | 2.16 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 9V | 3.08 μg/mL |
| 13vPnC 12 to <24 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 14 | 6.45 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 5 | 2.33 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 3 | 1.42 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 18C | 2.56 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 14 | 2.24 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 4 | 3.37 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 19F | 2.53 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 6A | 2.96 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 7F | 4.92 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 23F | 1.55 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 19A | 6.03 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 9V | 2.67 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Additional Serotypes - Serotype 1 | 1.78 μg/mL |
| 13vPnC 24 to < 72 Months of Age | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | Common Serotypes - Serotype 6B | 3.41 μg/mL |
Primary
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Percentages of participants achieving World Health Organization (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: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
Population: Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 9V (n= 83,104,148) | 98.8 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 7F (n= 84,108,142) | 100.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 18C (n= 83,109,151) | 100.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 6A (n= 84,110,150) | 100.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 23F (n= 84,110,151) | 98.8 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 19F (n=84,110,147) | 97.6 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 4 (n= 84,110,151) | 100.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 6B (n=83,110,150) | 98.8 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 1 (n= 83,108,149) | 100.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 19A (n=84,110,150 | 100.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 5 (n= 84,107,152) | 97.6 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 3 (n= 83,108,149) | 98.8 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 14 (n= 84,108,135) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 3 (n= 83,108,149) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 5 (n= 84,107,152) | 99.1 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 6A (n= 84,110,150) | 98.2 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 9V (n= 83,104,148) | 99.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 7F (n= 84,108,142) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 19A (n=84,110,150 | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 14 (n= 84,108,135) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 4 (n= 84,110,151) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 18C (n= 83,109,151) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 19F (n=84,110,147) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 1 (n= 83,108,149) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 6B (n=83,110,150) | 100.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 23F (n= 84,110,151) | 92.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 19A (n=84,110,150 | 100.0 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 4 (n= 84,110,151) | 99.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 6B (n=83,110,150) | 99.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 9V (n= 83,104,148) | 98.6 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 14 (n= 84,108,135) | 88.1 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 18C (n= 83,109,151) | 98.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 23F (n= 84,110,151) | 93.4 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 1 (n= 83,108,149) | 96.6 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 3 (n= 83,108,149) | 97.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 5 (n= 84,107,152) | 98.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 6A (n= 84,110,150) | 100.0 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Additional Serotypes - Serotype 7F (n= 84,108,142) | 99.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination | Common Serotypes - Serotype 19F (n=84,110,147) | 98.0 percentage of participants |
Secondary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild | 32.6 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any | 36.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe | 0.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate | 16.3 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild | 41.9 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any | 48.8 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant | 1.2 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any | 15.1 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate | 11.6 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant | 0.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any | 33.3 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any | 44.5 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild | 36.7 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate | 24.8 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any | 70.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild | 55.5 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate | 38.2 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe | 0.0 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild | 28.2 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild | 37.4 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any | 42.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate | 20.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any | 36.9 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant | 4.1 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate | 25.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe | 0.0 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any | 50.0 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any | 46.0 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild | 40.2 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant | 3.5 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe | 0.0 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate | 9.3 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any | 15.1 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate | 14.0 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild | 28.7 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any | 32.2 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any | 54.7 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild | 36.2 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate | 12.1 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any | 43.7 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild | 44.7 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe | 0.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate | 25.5 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any | 41.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant | 4.1 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Severe | 0.0 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Severe | 0.0 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Significant | 6.4 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Any | 25.0 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Moderate | 11.3 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Any | 37.8 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Swelling - Mild | 20.5 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Mild | 31.3 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness - Any | 15.2 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Redness - Moderate | 12.5 percentage of participants |
Secondary
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported 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 subjects who received at least 1 dose of vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep | 24.1 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to treat symptoms | 9.2 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C | 1.2 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C | 0.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite | 19.5 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to prevent symptoms | 8.0 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability | 24.1 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep | 9.2 percentage of participants |
| 13vPnC 7 to <12 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C | 3.4 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep | 13.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite | 22.2 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C | 3.7 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep | 19.4 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C | 0.9 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C | 0.0 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability | 30.6 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to treat symptoms | 10.1 percentage of participants |
| 13vPnC 12 to <24 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to prevent symptoms | 13.8 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C | 0.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C | 0.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to prevent symptoms | 4.8 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to treat symptoms | 2.7 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C | 0.0 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite | 16.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep | 11.6 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability | 14.3 percentage of participants |
| 13vPnC 24 to < 72 Months of Age | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep | 6.8 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability | 34.5 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite | 17.2 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to treat symptoms | 9.3 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep | 18.4 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to prevent symptoms | 4.7 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C | 2.3 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C | 8.1 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep | 9.3 percentage of participants |
| 13vPnC Group 1 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C | 0.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C | 0.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C | 5.1 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C | 0.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite | 25.5 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability | 34.0 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep | 10.1 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep | 20.4 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to treat symptoms | 13.3 percentage of participants |
| 13vPnC Group 2 - Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to prevent symptoms | 14.3 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability | 24.7 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to prevent symptoms | 5.1 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Use of antipyretic medication to treat symptoms | 7.6 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased appetite | 17.5 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >40°C | 0.0 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever >39°C but ≤40°C | 1.3 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fever ≥38°C but ≤39°C | 5.1 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decreased sleep | 15.0 percentage of participants |
| 13vPnC Group 1 - Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased sleep | 2.6 percentage of participants |