Phase 3
Completed N=604
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Vaccines, Pneumococcal
Source: ClinicalTrials.gov NCT00366340 ↗
Enrolled (actual)
604
Serious AEs
4.1%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series — 98.2; 98.2; 77.5; 87.1 Percentage of Participants
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
98.2; 98.2; 77.5; 87.1; 98.6; 96.4 | — |
| PRIMARY Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
2.18; 2.99; 0.98; 1.49; 1.65; 1.96 | — |
| PRIMARY Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. |
100.0; 100.0; 96.0; 98.9; 100.0; 100.0 | — |
| PRIMARY Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
1573.29; 1860.79; 744.43; 1160.76; 4937.84; 5379.51 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose |
89.5; 86.9; 100.0; 100.0; 58.4; 54.0 | — |
| PRIMARY Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose |
1.23; 1.00; 11.79; 10.24 | — |
| PRIMARY Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose |
0.36; 0.53; 2.67; 3.08 | — |
| PRIMARY Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose |
145.19; 165.25; 1118.05; 1195.82 | — |
| PRIMARY Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose |
0.46; 0.58; 4.16; 5.07; 0.97; 1.06 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions |
33.0; 32.6; 29.2; 31.5; 27.1; 21.3 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) |
43.5; 38.7; 46.8; 48.4; 46.3; 36.6 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) |
58.7; 62.0; 12.6; 8.9; 0.6; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 2 months (56 to 112 days) at time of enrollment.
- Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
- Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
- Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.
- Major known congenital malformation or serious chronic disorder.
- 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. Did not include resolving syndromes due to birth trauma such as Erb palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- Participation in another investigational trial. Participation in purely observational studies was acceptable.
- Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Data sourced from ClinicalTrials.gov (NCT00366340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.