Brief Title
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Official Title
Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
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 to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T
vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after
the three-dose primary series.
The secondary objectives are:
- To describe in each group, the immunogenicity parameters for all antigens one month
after the third dose of the primary series
- To assess the overall safety in each group one month after the third dose of the primary
series.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Secondary Outcome
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Condition
Diphtheria
Intervention
DTaP-IPV-HB-PRP~T vaccine
Study Arms / Comparison Groups
Group 1
Description: Participants receive vaccine Batch A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1189
Start Date
November 2006
Completion Date
July 2008
Primary Completion Date
April 2008
Eligibility Criteria
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.
Gender
All
Ages
2 Months - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT00404651
Organization ID
A3L11
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
April 2014