Safety and Immunogenicity of Tdap Vaccine Compared to DTaP vaccineas Fifth Dose Booster in Children 4 to 6 Years of Age

Active, not recruiting

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: EUCTR2015-003500-23-Outside-EU/EEA

Lead Sponsor: SANOFI PASTEUR INC.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 1045

Inclusion Criteria

1) Healthy, as determined by medical history and physical examination.
2) Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.
3) Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
4) Signed and dated informed assent form from the subject if required by the IRB.
5) Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
6) Documented vaccination history of 4 previous doses of DAPTACEL (consisting of 3 infant doses in the first year of life and a 4th dose in the 2nd year of life) or 4 previous doses of Pentacel and Prevnar®.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1045
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) Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
2) Planned participation in another clinical trial during the original trial period.
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
4) Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
5) Chronic illness at a stage that could interfere with trial conduct or completion.
6) Blood or blood-derived products received in the past 3 months.
7) Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
8) History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
9)Thrombocytopenia or bleeding disorder contraindicating IM vaccination.