Study of SP306 given intramuscularly compared to DT BIK® given subcutaneously in Japanese adolescents 11 to 12 years old?

• 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] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-003950-41-Outside-EU/EEA
• Lead Sponsor: SANOFI PASTEUR SA

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: 534

Inclusion Criteria

An individual had to fulfill all of the following criteria in order to be eligible for trial
enrollment:

I 01. Aged 11 or 12 years and considered health on the day of inclusion

I 02. Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively

I 03. Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination

I 04. Able to attend all scheduled visits and to comply with all trial procedures

I 05. 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: 534
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

An individual fulfilling any of the following criteria was excluded from trial enrollment:

E01. 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

E02. History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically

E03. Suspected or known 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

E04. Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis

E05. 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

E06. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

E07. Planned participation in another clinical trial during the present trial period

E08. Receipt of blood or blood–derived products in the past 3 months, that might interfere with assessment of the immune response

E09. 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

E10. Planned receipt of any vaccine during the trial period

E11. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection

E12. At high risk for diphtheria, tetanus or pertussis infection during the trial

E13. Known pregnancy, or a positive urine pregnancy test

E14. Currently breastfeeding a child

E15. Known thrombocytopenia or history of thrombocytopenia

E16. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding

E17. History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease

E18. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

E19. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

E20. 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

Study & Design

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