Healthy Subjects, Pneumococcal Infections
Conditions
Keywords
Infant Vaccine
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
1. Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment, 2. In good health as determined by medical history, physical examination and judgment of the investigator, 3. Subject must have been born ≥36 weeks of gestational age, 4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone, 5. Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.
Exclusion criteria
1. Previous vaccination with licensed or investigational pneumococcal vaccine, 2. Previous vaccination with Hib conjugate, DTaP or IPV vaccines, 3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines, 4. 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, 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection, 6. History of culture-proven invasive disease caused by S. pneumoniae, 7. Previous anaphylactic reaction to any vaccine or vaccine components, 8. Major known congenital malformation or serious chronic disorders, 9. Participation in another investigational study (however, observation-only trials are permitted), 10. Known or suspected immune deficiency/suppression, 11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions | Within 15 days after each dose | Local reaction events were collected using a paper worksheet. 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 (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category. |
| Percentage of Participants Reporting Pre-Specified Systemic Events | Within 15 days after each dose | Systemic events (fever \[Fv\] ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category. |
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | one month after 3-dose infant series (at 7 months of age) | Percentage 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. Exact 2-sided CI based on the observed proportion of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | One month after the infant series (7 months of age) | Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin \[FHA\], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented. |
| Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) | — |
| Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) | GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented. |
| Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) | — |
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | One month after the toddler dose (at 13 to 16 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. Exact 2-sided CI based on the observed proportion of participants. |
| Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) | — |
| Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | one month after the infant series (7 months of age) | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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 Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | One month after the toddler dose (13 to 16 months of age) | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer. |
| Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | One month after the Toddler Dose (13 to 16 months of age) | Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer. |
| Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) | — |
| Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | One month after 3-dose infant series (at 7 months of age) | Antibody 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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated. |
| Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) | Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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
United States
Participant flow
Recruitment details
Participants were recruited in the United States from September 2004 to September 2005.
Pre-assignment details
Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). | 121 |
| 7vPnC Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). | 126 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After Infant Series | Adverse Event | 1 | 1 |
| After Infant Series | Lost to Follow-up | 2 | 1 |
| After Infant Series | Other | 10 | 4 |
| After Infant Series | Physician Decision | 3 | 2 |
| After Infant Series | Protocol Violation | 1 | 1 |
| After Infant Series | Withdrawal by Subject | 1 | 4 |
| Infant Series | Lost Kaiser coverage | 0 | 1 |
| Infant Series | Lost to Follow-up | 10 | 4 |
| Infant Series | Non-compliant | 1 | 0 |
| Infant Series | Physician Decision | 3 | 1 |
| Infant Series | Protocol Violation | 1 | 0 |
| Infant Series | Sponsor request | 1 | 0 |
| Infant Series | Withdrawal by Subject | 2 | 5 |
| Toddler Dose | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Age Continuous | 9.2 weeks STANDARD_DEVIATION 1.4 | 9.1 weeks STANDARD_DEVIATION 1.2 | 9.2 weeks STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 58 Participants | 59 Participants | 117 Participants |
| Sex: Female, Male Male | 63 Participants | 67 Participants | 130 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 | 104 / 120 | 110 / 126 | 33 / 86 | 51 / 103 | 20 / 86 | 33 / 103 |
| serious Total, serious adverse events | 9 / 120 | 9 / 126 | 1 / 86 | 0 / 103 | 4 / 86 | 1 / 103 |
Outcome results
Primary
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage 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. Exact 2-sided CI based on the observed proportion of participants.
Time frame: one month after 3-dose infant series (at 7 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; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=94,108) | 96.81 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=94,108) | 97.87 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=94,106) | 96.81 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=94,107) | 98.94 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=94,107) | 88.30 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=93,107) | 100.00 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=94,106) | 97.87 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=93,106) | 96.77 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=94,107) | 97.87 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=94,105) | 98.94 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=94,108) | 94.68 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=94,107) | 100.00 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 (n=94,107) | 96.81 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=94,107) | 94.39 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 (n=94,107) | 99.07 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=94,107) | 88.79 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=94,108) | 99.07 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=94,107) | 97.20 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=94,106) | 99.06 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=94,106) | 97.17 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=94,108) | 95.37 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=94,108) | 25.00 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=94,107) | 14.02 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=93,107) | 42.06 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=93,106) | 33.96 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=94,105) | 6.67 percentage of participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-8.08, 2.33]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-9.93, 8.65]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-8.07, 2.26]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.96, 6.16]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-8.18, 2.36]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.84, 6.32]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-7.75, 5.86]
Comparison: For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [63.32, 81.07]
Comparison: For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [76.73, 91.05]
Comparison: For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [48.01, 67.42]
Comparison: For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [52.33, 72.2]
Comparison: For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [85.26, 96.54]
Comparison: For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [1.23, 11.86]
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reaction events were collected using a paper worksheet. 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 (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Within 15 days after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 34.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 20.2 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 3.4 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 21.8 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 2.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 8.4 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 21.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 20.2 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 19.4 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 17.9 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 2.4 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 43.5 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 5.6 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 19.4 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 19.4 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 16.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 16.4 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 3.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 28.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 13.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 16.2 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 2.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 1.8 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 3.4 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 36.4 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 8.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 19.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 17.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 17.8 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 17.1 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 16.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 4.7 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 17.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 16.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 24.3 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 0.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 16.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 6.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 19.7 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 25.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 18.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 18.1 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 17.2 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 2.6 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 4.3 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 2.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 2.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 24.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 18.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 3.5 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 18.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 24.7 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 22.4 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Any (n=119,124,111,118,107,117, 85,100) | 19.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Any (n=119,124,110,118,107,117,85,101) | 29.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Tenderness-Sig. (n=119,124,110,118,107,117,85,101) | 4.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mild (n=119,124,110,117,106,116,85,99) | 16.2 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Severe (n=119,124,108,117,106,116,85,99) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Any (n=119,124,110,118,107,117,85,100) | 17.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mild (n=119,123,110,117,107,116,85,100) | 17.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Erythema-Mod. (n=119,124,108,117,106,116,85,99) | 5.1 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Mod. (n=119,123,110,117,107,116,85,100) | 3.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Local Reactions | Induration-Sev. (n=119,123,110,117,107,116,85,100) | 0.0 percentage of participants |
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever \[Fv\] ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.
Time frame: Within 15 days after each dose
Population: The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 18.6 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 56.3 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 2.7 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 30.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 29.5 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 16.7 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 66.9 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 44.7 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 31.5 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 34.7 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 16.5 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 54.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 0.8 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 71.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 33.7 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 17.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 3.9 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 42.3 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 48.8 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 34.9 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 22.7 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 21.6 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 24.5 percentage of participants |
| 13vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 62.7 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 24.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 32.3 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 3.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 50.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 22.9 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 19.5 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 46.6 percentage of participants |
| 7vPnC Dose 2 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 56.8 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 20.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 21.5 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 2.0 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 42.9 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 51.4 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 34.6 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 36.1 percentage of participants |
| 13vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 27.1 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 30.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 41.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 53.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 18.8 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 43.0 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 0.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 47.9 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 20.4 percentage of participants |
| 7vPnC Dose 3 | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 17.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 14.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 2.6 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 22.4 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 13.1 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 27.9 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 38.8 percentage of participants |
| 13vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 29.4 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) | 35.3 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Increased Sleep (n=119,124,111,118,107,117,86,101) | 43.6 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Appetite (n=118,124,110,118,107,117,85,101) | 21.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >40°C (n=113,121,102,113,100,113,76,94) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) | 0.0 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94) | 12.8 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Decr. Sleep (n=118,124,110,118,107,117,84,101) | 14.9 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) | 27.7 percentage of participants |
| 7vPnC Toddler Dose | Percentage of Participants Reporting Pre-Specified Systemic Events | Irritability (n=118,124,110,118,107,117,85,101) | 47.5 percentage of participants |
Secondary
Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 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; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Diphtheria Toxoid | 0.86 IU/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Anti-Tetanus Toxoid | 0.93 IU/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Diphtheria Toxoid | 1.04 IU/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Anti-Tetanus Toxoid | 0.97 IU/mL |
95% CI: [0.57, 1.21]
Secondary
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody 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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Time frame: One month after 3-dose infant series (at 7 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;(n)=number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 (n=94,107) | 1.81 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=94,108) | 2.57 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=94,106) | 1.53 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=94,107) | 1.40 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=94,108) | 1.52 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=93,107) | 2.41 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=94,106) | 2.21 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=93,106) | 2.36 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=94,107) | 2.74 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=94,105) | 1.85 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=94,108) | 1.39 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=94,107) | 1.93 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=94,107) | 4.24 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=94,107) | 1.12 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 (n=94,107) | 2.40 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=94,107) | 2.86 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=94,108) | 1.78 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=94,107) | 5.19 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=94,106) | 2.46 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=94,106) | 2.58 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=94,108) | 1.81 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=94,108) | 0.06 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=94,107) | 0.09 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=93,107) | 0.28 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=93,106) | 0.25 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=94,105) | 0.07 μg/mL |
Comparison: For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [1.36, 2.16]
Comparison: For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.59, 0.96]
Comparison: For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.62, 1.48]
Comparison: For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.69, 1.05]
Comparison: For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.6, 1.11]
Comparison: For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.49, 0.79]
Comparison: For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.67, 1.09]
Comparison: For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.59, 1]
Comparison: For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [27.47, 57.63]
Comparison: For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [11.63, 20.81]
Comparison: For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [6.65, 11.29]
Comparison: For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [7.07, 13.04]
Comparison: For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [20.97, 34.22]
Secondary
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 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; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series | 1.99 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series | 1.64 μg/mL |
95% CI: [0.69, 2.14]
Secondary
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.
Time frame: one month after the infant series (7 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; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | 1257.74 milli International Units (mIU)/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | 1300.01 milli International Units (mIU)/mL |
95% CI: [0.63, 1.48]
Secondary
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 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; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - filamentous hemagglutinin (FHA) | 207.85 EU/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - pertussis toxoid (PT) | 98.68 EU/mL |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - pertactin | 141.23 EU/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - filamentous hemagglutinin (FHA) | 225.12 EU/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - pertussis toxoid (PT) | 96.58 EU/mL |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - pertactin | 135.51 EU/mL |
Comparison: Pertussis - FHA95% CI: [0.74, 1.15]
Comparison: Pertussis - PT95% CI: [0.83, 1.25]
Comparison: Pertussis - Pertactin95% CI: [0.76, 1.44]
Secondary
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 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; (n)= number of participants with a postinfant series blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 1 (n=61,64) | 483.72 titer |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 2 (n=61,64) | 368.26 titer |
| 13vPnC Dose 1 | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 3 (n=61,63) | 914.01 titer |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 1 (n=61,64) | 479.79 titer |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 2 (n=61,64) | 403.45 titer |
| 7vPnc Dose 1 | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 3 (n=61,63) | 812.75 titer |
Comparison: Polio Type 195% CI: [0.66, 1.53]
Comparison: Polio Type 295% CI: [0.56, 1.49]
Comparison: Polio Type 395% CI: [0.69, 1.84]
Secondary
Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer.
Time frame: One month after the Toddler Dose (13 to 16 months of age)
Population: All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=73,70) | 2147.58 titer |
| 13vPnC Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=71,72) | 802.24 titer |
| 7vPnc Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=73,70) | 599.90 titer |
| 7vPnc Dose 1 | Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=71,72) | 36.62 titer |
Secondary
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)
Population: All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 9V (n=83,100,78,94) | 0.43 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 4 (n=83,100,78,94) | 0.33 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 6B (n=82,98,78,93) | 0.84 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 14 (n=83,100,78,93) | 1.59 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=83,100,78,94) | 0.25 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=82,100,78,93) | 0.81 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=83,100,78,93) | 0.29 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 1 (n=83,90,78,91) | 0.68 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 3 (n=83,98,78,92) | 0.27 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 5 (n=83,92,78,78) | 1.01 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 6A (n=82,96,78,92) | 0.81 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 7F (n=83,91,78,85) | 0.58 μg/mL |
| 13vPnC Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype19A (n=83,100,78,93) | 0.85 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 14 (n=83,100,78,93) | 2.00 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 4 (n=83,100,78,94) | 0.48 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 6B (n=82,98,78,93) | 0.95 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 1 (n=83,90,78,91) | 0.04 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 9V (n=83,100,78,94) | 0.43 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype19A (n=83,100,78,93) | 0.64 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 5 (n=83,92,78,78) | 0.40 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 3 (n=83,98,78,92) | 0.09 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=82,100,78,93) | 0.60 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=83,100,78,94) | 0.40 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 6A (n=82,96,78,92) | 0.27 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 7F (n=83,91,78,85) | 0.04 μg/mL |
| 7vPnc Dose 1 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=83,100,78,93) | 0.38 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 6A (n=82,96,78,92) | 8.06 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 14 (n=83,100,78,93) | 7.68 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=83,100,78,94) | 2.57 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype19A (n=83,100,78,93) | 5.60 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=82,100,78,93) | 6.34 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=83,100,78,93) | 3.36 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 7F (n=83,91,78,85) | 2.67 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 1 (n=83,90,78,91) | 3.44 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 3 (n=83,98,78,92) | 1.11 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 5 (n=83,92,78,78) | 3.92 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 4 (n=83,100,78,94) | 2.86 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 6B (n=82,98,78,93) | 11.03 μg/mL |
| 13vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 9V (n=83,100,78,94) | 2.55 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 5 (n=83,92,78,78) | 0.56 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 1 (n=83,90,78,91) | 0.03 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 23F (n=83,100,78,93) | 4.79 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 14 (n=83,100,78,93) | 10.24 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 4 (n=83,100,78,94) | 4.09 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 19F (n=82,100,78,93) | 3.97 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 18C (n=83,100,78,94) | 4.08 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 9V (n=83,100,78,94) | 2.75 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Common Serotypes-Serotype 6B (n=82,98,78,93) | 11.85 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 3 (n=83,98,78,92) | 0.10 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype19A (n=83,100,78,93) | 2.82 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 7F (n=83,91,78,85) | 0.05 μg/mL |
| 7vPnC Dose 2 | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Additional Serotypes-Serotype 6A (n=82,96,78,92) | 1.68 μg/mL |
Secondary
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
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. Exact 2-sided CI based on the observed proportion of participants.
Time frame: One month after the toddler dose (at 13 to 16 months of age)
Population: The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=78,93) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=78,94) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=78,92) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=78,93) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=78,93) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=78,91) | 100.00 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=78,92) | 92.3 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=78,78) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=78,85) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=78,93) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=78,94) | 97.4 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=78,93) | 100.0 percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=78,94) | 98.7 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 4 (n=78,94) | 98.9 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 5 (n=78,78) | 70.5 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 18C (n=78,94) | 100.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=78,92) | 88.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 14 (n=78,93) | 100.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 9V (n=78,94) | 100.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 19F (n=78,93) | 100.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 7F (n=78,85) | 5.9 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 23F (n=78,93) | 97.8 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Common Serotypes - Serotype 6B (n=78,93) | 100.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 1 (n=78,91) | 2.2 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=78,93) | 100.0 percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 3 (n=78,92) | 8.7 percentage of participants |
Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-7.9, 3.6]
Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.6, 4]
Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-6.9, 2.8]
Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.6, 4]
Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.7, 3.9]
Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.6, 4]
Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.6, 7.7]
Comparison: For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [92.3, 99.7]
Comparison: For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [73.2, 90.8]
Comparison: For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [19.7, 40.9]
Comparison: For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [5.9, 20.4]
Comparison: For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [86.8, 98.1]
Comparison: For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.6, 4]
Secondary
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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 the infant series (7 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;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=22,24) | 77.27 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=27,30) | 92.59 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=27,27) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=27,30) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=27,30) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=25,25) | 84.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=30,33) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=25,29) | 96.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=22,24) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 (n=30,33) | 96.67 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=27,26) | 92.59 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=30,32) | 83.33 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=25,29) | 80.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 19F (n=25,25) | 80.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 6A (n=25,29) | 48.28 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 4 (n=30,33) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 9V (n=27,27) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 7F (n=22,24) | 20.83 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 14 (n=27,30) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 19A (n=22,24) | 12.50 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 18C (n=27,30) | 96.67 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 23F (n=27,26) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 1 (n=30,32) | 6.25 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 3 (n=25,29) | 3.45 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Common Serotypes - Serotype 6B (n=27,30) | 93.33 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Additional Serotypes - Serotype 5 (n=30,33) | 6.06 Percentage of participants |
Secondary
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer.
Time frame: One month after the toddler dose (13 to 16 months of age)
Population: All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=73,70) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=71,72) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 6A (n=73,70) | 90.0 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Additional Serotypes - Serotype 19A (n=71,72) | 51.4 Percentage of participants |
Secondary
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin \[FHA\], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.
Time frame: One month after the infant series (7 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;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - Pertussis Toxoid 43.00 EU/mL (n=65,68) | 89.23 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 3 (antibody threshold ≥1:8) (n=61,63) | 98.36 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - Pertactin 18.00 EU/mL (n=65,68) | 96.92 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Tetanus 0.1 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Tetanus 0.01 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Hib (PRP) 0.15 μg/mL (n=84,87) | 89.29 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Hepatitis b 10 mIU/mL (n=38,48) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Hib (PRP) 1.0 μg/mL (n=84,87) | 70.24 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 2 (antibody threshold ≥1:8) (n=61,64) | 98.36 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Diphtheria 0.01 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - FHA 82.00 EU/MI (n=65,68) | 93.85 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Diphtheria 0.1 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 13vPnC Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 1 (antibody threshold ≥1:8) (n=61,64) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Diphtheria 0.1 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Tetanus 0.1 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 1 (antibody threshold ≥1:8) (n=61,64) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 2 (antibody threshold ≥1:8) (n=61,64) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Polio Type 3 (antibody threshold ≥1:8) (n=61,63) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Hepatitis b 10 mIU/mL (n=38,48) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - FHA 82.00 EU/MI (n=65,68) | 95.59 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - Pertussis Toxoid 43.00 EU/mL (n=65,68) | 95.59 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Pertussis - Pertactin 18.00 EU/mL (n=65,68) | 95.59 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Hib (PRP) 0.15 μg/mL (n=84,87) | 86.21 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Hib (PRP) 1.0 μg/mL (n=84,87) | 63.22 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Diphtheria 0.01 IU/mL (n=38,48) | 100.00 Percentage of participants |
| 7vPnc Dose 1 | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Tetanus 0.01 IU/mL (n=38,48) | 100.00 Percentage of participants |
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated95% CI: [-7.22, 13.73]
Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated95% CI: [-7.28, 21.14]
Comparison: For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated95% CI: [-9.38, 7.73]
Comparison: For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated95% CI: [-9.38, 7.73]
Comparison: For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated95% CI: [-5.97, 5.68]
Comparison: For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated95% CI: [-8.8, 4.24]
Comparison: For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated95% CI: [-8.8, 4.21]
Comparison: For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated95% CI: [-9.38, 7.73]
Comparison: For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated95% CI: [-11, 6.99]
Comparison: For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated95% CI: [-17.03, 3.16]
Comparison: For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated95% CI: [-6.79, 9.68]