Immunogenicity and Safety of Tetraxim Versus Local DTaP + IPV

• Conditions: Healthy volunteers: indicated for primary vaccination in infants for active immunization against diphtheria, tetanus, pertussis and poliomyelitis.; MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005348-33-Outside-EU/EEA
• Lead Sponsor: SANOFI PASTEUR LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

1) Aged 56 to 70 days inclusive on the day of inclusion
2) Born at full term pregnancy (>37 weeks) with a birth weight = 2.5 kg
3) Informed consent form signed by the parent(s) or other legal representative
4) Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 442
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 (first) trial vaccination.
2) Planned participation in another clinical trial during the present trial period.
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
4) Systemic hypersensitivity to any of the vaccine components or history of a 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 or planned administration during the trial (including immunoglobulins).
7) Any vaccination in the 3 weeks preceding the first trial vaccination.
8) History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically).
9) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
10) Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
11) History of major neurological diseases or seizures.
12) Febrile illness (rectal temperature = 38.0°C or axillary temperature = 37.4°C) on the day of inclusion.
13) Known family history of congenital or genetic immuno-deficiency.

Study & Design

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