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

Sanofi

Status and phase

Completed

Phase 2

Phase 1

Conditions

Diphtheria

Tetanus

Pertussis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01689324

U1111-1124-7671 (Other Identifier)

Td540

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

11 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.