Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
NCT ID: NCT00315055
Last Updated: 2014-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2006-07-31
2008-02-29
Brief Summary
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Immunogenicity
* To assess pre- and post-primary series
* To assess pre- and post-booster 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
NONE
Study Groups
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Group 1: DTaP-IPV-Hep B-PRP-T
Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T); One dose each at 2, 3, and 4 months of age.
DTaP-IPV-HB-PRP~T vaccine
0.5 mL, Intramuscular (IM)
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC
Participants will receive 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.
DTaP-IPV//PRP~T combined
0.5 mL, IM
Hepatitis B vaccine
0.5 mL, IM
Interventions
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DTaP-IPV-HB-PRP~T vaccine
0.5 mL, Intramuscular (IM)
DTaP-IPV//PRP~T combined
0.5 mL, IM
Hepatitis B 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 the parent(s) or other legal representative(s) and an institution official other than an investigator
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 (except BCG) in the 4 weeks preceding the first trial vaccination
* Vaccination planned in the 4 weeks following trial vaccination
* History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
* Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures
* Febrile (axillary temperature 37.4°C \[rectal equivalent temperature \>=38.0°C\]) or acute illness on the day of inclusion.
50 Days
71 Days
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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Clinical Trials
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Ankara, , Turkey (Türkiye)
Countries
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Related Links
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Related Info
Other Identifiers
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A3L10
Identifier Type: -
Identifier Source: org_study_id
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