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

• Conditions: Active immunization against tetanus, diphtheria and pertussis; MedDRA version: 18.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005628-25-Outside-EU/EEA
• Lead Sponsor: Sanofi-Aventis K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Aged 11 or 12 years and considered health on the day of inclusion

2. Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively

3. Completed childhood vaccination against diphtheria, pertussis and tetanus (ie, received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination

4. Able to attend all scheduled visits and to comply with all trial procedures

5. For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test
Are the trial subjects under 18? yes
Number of subjects for this age range: 43
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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

2. History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically

3. 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

4. Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis

5. 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

6. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

7. Planned participation in another clinical trial during the present trial period

8. Receipt of blood or blood–derived products in the past 3 months, that might interfere with assessment of the immune response

9. 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

10. Planned receipt of any vaccine during the trial period

11. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection

12. At high risk for diphtheria, tetanus or pertussis infection during the trial

13. Known pregnancy, or a positive urine pregnancy test

14. Currently breastfeeding a child

15. Known thrombocytopenia, contraindicating IM vaccination, or a history of thrombocytopenia

16. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

17. History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease

18. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

19. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

20. 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 indentified as a spouse or child (whether natural or adopted) of such an employee

Temporary contraindications

A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
• Febrile illness (temperature =37.5°C)
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
• Antipyretics/analgesics/non steroidal anti-inflammatory drugs (NSAIDs) (considered as a single category) have been administered within 4 hours prior to vaccination.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified