Phase 3
Completed N=269
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Pneumococcal Vaccines
Source: ClinicalTrials.gov NCT00464945 ↗
Enrolled (actual)
269
Serious AEs
3.5%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series — 97.7; 96.9; 77.3; 74.0 percentage of participants
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series |
97.7; 96.9; 77.3; 74.0; 98.4; 96.2 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions |
18.8; 20.0; 20.3; 17.2; 15.3; 12.6 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) |
18.2; 19.2; 16.3; 20.0; 11.3; 17.4 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) |
14.0; 13.2; 0.9; 0.9; 0.0; 0.0 | — |
| PRIMARY Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series |
2.09; 1.55; 0.80; 0.83; 1.28; 1.21 | — |
Eligibility Criteria
Inclusion criteria
- Aged 2 months (42 to 98 days) at time of enrollment.
- Available for entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion criteria
- Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, 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.
- Major known congenital malformation or serious chronic disorders.
- 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.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Data sourced from ClinicalTrials.gov (NCT00464945). 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.