Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
NCT ID: NCT00514709
Last Updated: 2016-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1843 participants
INTERVENTIONAL
2007-09-30
2009-04-30
Brief Summary
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Primary Objectives:
* To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
* To describe the effect of a booster dose of DTaP-HB-PRP\~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.
Secondary Objective:
* To describe the safety profile of the booster dose of the DTaP-HB-PRP\~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).
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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-Hep B-PRP-T + OPV vaccine group
DTaP-HB PRP~T Combined Vaccine
0.5 mL, Intramuscular (IM)
Oral Polio Vaccine
Oral co-administered with study vaccine.
Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
DTaP-HB-PRP~T vaccine
0.5 mL, IM
Oral Polio Vaccine
Oral co-administered with study vaccine.
Interventions
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DTaP-HB PRP~T Combined Vaccine
0.5 mL, Intramuscular (IM)
DTaP-HB-PRP~T vaccine
0.5 mL, IM
Oral Polio Vaccine
Oral co-administered with study vaccine.
Eligibility Criteria
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Inclusion Criteria
* Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth
* Informed consent form signed by one parent or legal representative if appropriate (independent witness 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 (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
* Known 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 in the last 3 months
* Any vaccination in the 4 weeks preceding the trial vaccination
* Vaccination planned in the 4 weeks following the trial vaccination
* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
* History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
* Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the primary series
* Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
* Serious adverse event related to any vaccination in the AL201 study.
12 Months
18 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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City of Muntinlupa, Alabang Junction Alabang, Philippines
City of Muntinlupa, Alabang, Philippines
City of Muntinlupa, Bayanan Annex, Philippines
City of Muntinlupa, Cupang, Philippines
City of Muntinlupa, Filinvest, Philippines
City of Muntinlupa, Putatan, Philippines
City of Muntinlupa, Tunasan, Philippines
Countries
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Related Links
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Related Info
Other Identifiers
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AL204
Identifier Type: -
Identifier Source: org_study_id
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