Status:
COMPLETED
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\~T vaccine is consistent. The primary objective is ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Two months old infants on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by one or both parents or by the guardian and two independent witnesses
- Able to attend all scheduled visits and to comply with all trial procedures
- Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
- Exclusion Criteria :
- Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency
- 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
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
- Any vaccination in the four weeks preceding the first trial visit
- Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
- Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
- Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of seizures
- Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1189 Patients enrolled
Trial Details
Trial ID
NCT00404651
Start Date
November 1 2006
End Date
July 1 2008
Last Update
May 9 2014
Active Locations (6)
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1
Estado de México, Mexico, 56613
2
Estado de México, Mexico
3
Insurgentes Cuicuilco, Mexico
4
Monterrey, Mexico