Clinical Trial: Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

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

Official Title: Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

Brief Summary:

This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.

Primary Objective:

  • To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents

Secondary Objective:

  • To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Detailed Summary: All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

  • Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ]
    Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.
  • Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ]

    Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.

    Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.

  • Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ]
    Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4)

    Original Primary Outcome: Percentage of participants with booster responses to Tdap vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ]

    Anti-diphtheria antibodies will be assessed by a toxin neutralization test. Anti-tetanus and anti-pertussis antibodies will be assessed by enzyme linked immunosorbent assay (ELISA). Diphtheria and tetanus response is a post-vaccination antitoxin concentrations ≥0.1 IU/mL. Booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration.


    Current Secondary Outcome:

    Original Secondary Outcome: Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial. [ Time Frame: Day 0 up to Day 28 post-vaccination ]

    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.


    Information By: Sanofi

    Dates:
    Date Received: September 17, 2012
    Date Started: September 2012
    Date Completion:
    Last Updated: February 19, 2014
    Last Verified: February 2014