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

NCT01689324 | Completed Phase 1 Results

• 2 other identifiers: Td540U1111-1124-7671
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Pertussis; Tetanus; Diphtheria

Keywords

Pertussis; Tetanus; Diphtheria; Acellular pertussis; ADACEL®; Tdap vaccine

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®

  Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.

  Day 28 post-vaccination

• Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®

  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.

  Day 28 post-vaccination

• Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®

  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), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)

  Day 28 post-vaccination

Other Outcomes (7)

• Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®

  Day 0 pre-vaccination

• Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®

  Day 0 (pre-vaccination) and day 28 post-vaccination

• Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®

  Day 0 (pre-vaccination) and day 28 post-vaccination

Study Arms (1)

Study Group

EXPERIMENTAL

Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.

Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis

Interventions

(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis BIOLOGICAL

0.5 mL, Intramuscular

Also known as: ADACEL®, Tdap Vaccine

Study Group

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively
• Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e, received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular pertussis vaccine absorbed \[DTaP vaccine\]), confirmed by checking immunization records and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (DT) vaccination
• Able to attend all scheduled visits and to comply with all trial procedures
• For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.

You may not qualify if:

• Any conditions or diseases which, in the opinion of the investigator
• would pose a health risk to the subject
• or might interfere with the ability to participate fully in the study
• or might interfere with evaluation of the vaccine
• or would otherwise make participation inappropriate according to the investigator's clinical judgment
• History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
• Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
• Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
• Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
• Planned participation in another clinical trial during the present trial period
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response
• Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
• Planned receipt of any vaccine during the trial period
• Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
• At high risk for diphtheria, tetanus or pertussis infection during the trial

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Nagano, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Whooping Cough; Tetanus; Diphtheria

Interventions

adacel

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur K.K

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: February 21, 2014
• Results First Posted: February 21, 2014

Record last verified: 2014-02

Locations

JP (3)