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

NCT ID: NCT01689324

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-05-31

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 Description

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.

Conditions

Pertussis; Tetanus; Diphtheria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

ADACEL®; Tdap Vaccine

Eligibility Criteria

Inclusion Criteria

• Aged 11 or 12 years on the day of inclusion
• 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.

Exclusion Criteria

• 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
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
• 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
• Known pregnancy, or a positive urine pregnancy test
• Currently breastfeeding a child
• Known thrombocytopenia, contraindicating intramuscular (IM) vaccination, or a history of thrombocytopenia
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
• History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
• Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur K.K

Locations

Aichi, , Japan

Ibaraki, , Japan

Nagano, , Japan

Countries

Japan

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1124-7671

Identifier Type: OTHER

Identifier Source: secondary_id

Td540

Identifier Type: -

Identifier Source: org_study_id