Clinical Trial: Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

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

Official Title: Phase 1 Extension Study to Evaluate Antibody Persistence Approximately 3 Years After Administration of Different Dosages of Acellular Pertussis or Tetanus-Diphtheria-acellular Pertussis Booster Vaccin

Brief Summary:

The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113_01 study.

There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn.

No vaccine was administered and no safety data was collected in this study.


Detailed Summary:
Sponsor: Novartis

Current Primary Outcome:

  • Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. [ Time Frame: Day 1 ]

    The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator.

    Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.

  • Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. [ Time Frame: Day 1 ]

    The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator.

    Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.

  • Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. [ Time&

    Original Primary Outcome:

    • Geometric Mean Concentrations (GMCs) of anti-PT, anti-FHA and anti-PRN antibody at study V113_01E1 day 1. [ Time Frame: Day 1 ]
    • Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody for concentrations as measured at V113_01E1 day 1 vs. all V113_01 time points. [ Time Frame: V113_01E1 day 1 vs. all V113_01 time points. ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Novartis

    Dates:
    Date Received: February 27, 2015
    Date Started: April 2015
    Date Completion:
    Last Updated: February 24, 2016
    Last Verified: February 2016