Clinical Trial: 13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

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

Official Title: A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who

Brief Summary: The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination [ Time Frame: One month (28 to 42 days) after vaccination ]
    Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.
  • Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ]
    Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).
  • Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ]
    Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:&

    Original Primary Outcome:

    • Serotype specific Opsonophagocytic Activity (OPA) geometic mean titers (GMTs) in each group 50 to 64 years and => 65 years [ Time Frame: 1 month (28 to 42 days) after vaccination ]
    • Collection of incidence rates of local reactions, systemic events, including the use of antipyretics and pain medication. [ Time Frame: 1 month (28 to 42 days) after vaccination ]


    Current Secondary Outcome:

    • Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination [ Time Frame: One month (28 to 42 days) after vaccination ]
      Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
    • Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination [ Time Frame: Pre-vaccination to 1 month (28 to 42 days) after vaccination ]
      Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.


    Original Secondary Outcome:

    • Proportion of subjects who achieved serotype specific Opsonophagocytic Activity (OPA) titers greater than lower limit of quantitation (LLOQ) in each group 50 to 64 years and => 65 years [ Time Frame: 1 month (28 to 42 days) after vaccination ]
    • Serotype specific foldrise Opsonophagocytic Activity (OPA) geometic mean titers (GMTs) in each group 50 to 64 years and => 65 years [ Time Frame: 1 month (28 to 42 days) after vaccination ]


    Information By: Pfizer

    Dates:
    Date Received: June 22, 2011
    Date Started: July 2011
    Date Completion:
    Last Updated: January 18, 2013
    Last Verified: January 2013