Phase 3
N=105
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Vaccines, Pneumococcal Conjugate Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT00500357 ↗Enrolled (actual)
105
Serious AEs
0.9%
Results posted
Feb 2011
Primary outcome: Primary: Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) — 198; 78; 126; 104 geometric mean titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) |
198; 78; 126; 104; 2210; 1254 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) |
184; 81; 131; 104; 1457; 1406 | — |
| SECONDARY Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) |
7.67; 4.99; 2.60; 1.35; 4.68; 2.96 | — |
| SECONDARY Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) |
7.29; 4.99; 2.46; 1.36; 3.93; 2.96 | — |
Summary
This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.
Eligibility Criteria
- Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
- Generally healthy male or female adults 65 years of age or older
- Available for the duration of the trial - approximately 1 month
- No history of severe adverse reaction associated with a vaccine
- MMSE score less than or equal to 21 was an exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT00500357). 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.