ot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants

• Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus; MedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004455-39-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1190

Inclusion Criteria

1) Two months old infants (50 to 71 days old) on the day of inclusion
2) Born at full term of pregnancy (> or =37 weeks) with a birth weight > or =2.5 kg
3) Informed Consent Form signed by one or both parents or by the guardian and two independent witnesses
4) Able to attend all scheduled visits and to comply with all trial procedures
5) Received Bacillus Calmette-Guerin (BCG) vaccine between birth and 1 month of life in agreement with the national immunization calendar
Are the trial subjects under 18? yes
Number of subjects for this age range: 1190
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 four weeks preceding the (first) trial vaccination
2) Planned participation in another clinical trial during the present trial period
3) Congenital or acquired immunodeficiency
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 since birth
7) Any vaccination in the 4 weeks preceding the first trial visit
8) Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
9) Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
10) Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
11) Known personal or maternal history of HIV, hepatitis B (HBsAg) or hepatitis C seropositivity
12) Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
13) History of seizures
14) Febrile (rectal equivalent temperature =38.0°C) or acute illness on the day of inclusion

Study & Design

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