Clinical Trial: Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

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

Official Title: Phase I, Randomized, Controlled, Observer-Blind, Dose-Ranging Study of Acellular Pertussis and Tetanus-Diptheria-Acellular Pertussis Booster Vaccine in Adults Ages 18 to 4

Brief Summary: This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome:

  • The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine [ Time Frame: Day 1 through 7 after vaccination ]
    The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
  • The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine [ Time Frame: From day 1 to day 365 ]
    The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
  • Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]
    The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
  • GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booste

    Original Primary Outcome:

    • assess the safety profiles of all study vaccines against comparator, as measured by local and systemic reactions, patient reported outcomes and adverse events/serious adverse events (AEs/SAEs) [ Time Frame: 30 days after vaccination ]
    • select up to 4 vaccine dose candidates for further study based on immunogenicity responses to antigen components at Day 30 provided the safety profiles are comparable. [ Time Frame: 30 days after vaccination ]
    • evaluate antibody titers for Pertussis and Seroresponse rates for Diphtheria, and Tetanus antigens prior to and 1 month following vaccination. [ Time Frame: 30 days after vaccination ]


    Current Secondary Outcome:

    • Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. [ Time Frame: Day 30 post vaccination ]
      Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.
    • GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]
      The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.
    • GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens [ Time Frame: Day 30 post vaccination/Day 1 ]
      The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.


    Original Secondary Outcome: evaluate Seroresponse rates for Pertussis antigens and antibody titers to Diphtheria, and Tetanus Prior to and 1 month following vaccination. [ Time Frame: 30 days after vaccination ]

    Information By: Novartis

    Dates:
    Date Received: February 6, 2012
    Date Started: March 2012
    Date Completion:
    Last Updated: March 3, 2016
    Last Verified: March 2016