Phase 3
N=720
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
Pneumococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00574548 ↗Enrolled (actual)
720
Serious AEs
1.5%
Results posted
May 2011
Primary outcome: Primary: Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0) — 148; 148; 125; 80 geometric mean titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13 valent Pneumococcal Conjugate Vaccine (Biological); 23-valent Pneumococcal Polysaccharide Vaccine (Biological)
- Age
- Adult · 60+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0) |
148; 148; 125; 80; 1385; 1357 | — |
| PRIMARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1) |
148; 77; 125; 50; 1385; 935 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0) |
215; 142; 73; 89; 2255; 1214 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0) |
220; 140; 74; 129; 2517; 1430 | — |
Summary
The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.
Eligibility Criteria
Inclusion Criteria
- Male or Female, aged 60 to 64 years.
- Healthy.
Exclusion Criteria
- Previous vaccination with any licensed or experimental pneumococcal vaccine.
- History of severe adverse reaction associated with a vaccine.
- Immunodeficiency.
Data sourced from ClinicalTrials.gov (NCT00574548). 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.