Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
NCT ID: NCT00404651
Last Updated: 2014-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1189 participants
INTERVENTIONAL
2006-11-30
2008-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1
Participants receive vaccine Batch A
DTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)
Group 2
Participants receive vaccine Batch B
DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
Group 3
Participants receive vaccine Batch C
DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
Group 4
Participants receive Infanrix hexa™
DTaP-HBV-IPV vaccine
0.5 mL, IM
Interventions
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DTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)
DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
DTaP-HBV-IPV vaccine
0.5 mL, IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Estado de México, , Mexico
Estado de México, , Mexico
Insurgentes Cuicuilco, , Mexico
Monterrey, , Mexico
Puebla City, , Mexico
Tlalpan, , Mexico
Countries
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Related Links
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Related Info
Other Identifiers
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A3L11
Identifier Type: -
Identifier Source: org_study_id
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