Phase 3 Completed N=1,160 Randomized Quadruple-blind Prevention

Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

Pneumococcal Infections

Source: ClinicalTrials.gov NCT00492557 ↗

Enrolled (actual)

1,160

Serious AEs

0.8%

Results posted

Feb 2012

Primary outcomePrimary: 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

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).

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.