Phase 3
N=938
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00546572 ↗Enrolled (actual)
938
Serious AEs
3.3%
Results posted
May 2011
Primary outcome: Primary: Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) — 81; 55; 55; 49 geometric mean titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13 valent Pneumococcal Conjugate Vaccine (Biological); 23vPS (Biological)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) |
81; 55; 55; 49; 545; 203 | — |
| PRIMARY Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) |
71.1; 27.3 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) |
903; 94 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) |
79; 76; 55; 55; 614; 487 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) |
76; 55; 55; 49; 472; 203 | — |
| SECONDARY Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) |
1134; 94 | — |
Summary
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
Eligibility Criteria
Inclusion Criteria
- Male or Female aged 70 years or older.
- Documented vaccination with 1 dose of 23vPS at least 5 years previous.
- Healthy.
Exclusion Criteria
- Receipt of more than one dose of 23vPS prior to enrollment.
- History of severe adverse reaction to a vaccine.
- Immunodeficiency.
Data sourced from ClinicalTrials.gov (NCT00546572). 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.