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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated

Brief 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).

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) [ Time Frame: Baseline and 1 month after TIV vaccination ]
    Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
  • 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 1 month after 13vPnC vaccination ]
    IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.


Original Primary Outcome: To assess the immune responses of 13vPnC and TIV when given concomitantly or alone. 13vPnC response is measured by serotype-specific immunoglobulin G (IgG) concentrations; TIV response is measured by the standard hemagglutination inhibition assay.

Current Secondary Outcome:

Original Secondary Outcome: To assess the safety profile of 13vPnC when given concomitantly with TIV or alone, as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).

Information By: Pfizer

Dates:
Date Received: June 26, 2007
Date Started: September 2007
Date Completion:
Last Updated: January 17, 2012
Last Verified: January 2012