Phase 3
N=1,160
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00492557 ↗Enrolled (actual)
1,160
Serious AEs
0.8%
Results posted
Feb 2012
Primary outcome: Primary: TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) — 80.3; 78.6; 58.0; 62.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); 13vPnC + TIV (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) |
80.3; 78.6; 58.0; 62.6; 52.2; 54.0 | — |
| PRIMARY 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) |
2.52; 3.20; 1.08; 1.15; 2.15; 3.24 | — |
Summary
The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).
Eligibility Criteria
Inclusion Criteria
- Generally healthy male or female adults 65 years of age or older.
- Available for the duration of the trial - approximately 2 months.
- No previous vaccination with any pneumococcal vaccine.
- No history of severe adverse reaction associated with a vaccine.
- No allergy to egg proteins (eggs or egg products) and chicken proteins.
Data sourced from ClinicalTrials.gov (NCT00492557). 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.