Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
NCT ID: NCT00343889
Last Updated: 2013-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
379 participants
INTERVENTIONAL
2006-08-31
2008-04-30
Brief Summary
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The primary objective is:
* To demonstrate that the pentavalent DTaP-HB-PRP\~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.
The secondary objectives are:
* To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
* To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine
Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
DTaP-HB-PRP~T vaccine + OPV
0.5 mL, Intramuscular
Oral Polio Vaccine
Oral co-administered with study vaccine
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age.
Tritanrix-HepB/Hib™ + OPV vaccine
0.5 mL, Intramuscular
Oral Polio Vaccine
Oral co-administered with study vaccine
Interventions
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DTaP-HB-PRP~T vaccine + OPV
0.5 mL, Intramuscular
Tritanrix-HepB/Hib™ + OPV vaccine
0.5 mL, Intramuscular
Oral Polio Vaccine
Oral co-administered with study vaccine
Eligibility Criteria
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Inclusion Criteria
* Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
* 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.
* Chronic illness at a stage that could interfere with the conduct or completion of the trial
* Blood or blood-derived products received since birth
* HB vaccination since birth
* Any vaccination in the four weeks preceding the first trial vaccination
* Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
* Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
* Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
* History of seizures
* Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
42 Days
50 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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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Manila, , Philippines
Quezon City, , Philippines
Countries
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Related Links
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Related Info
Other Identifiers
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AL203
Identifier Type: -
Identifier Source: org_study_id