Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
NCT ID: NCT00534833
Last Updated: 2013-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
362 participants
INTERVENTIONAL
2007-09-30
2009-03-31
Brief Summary
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Primary Objectives:
To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \[OPV\]).
Secondary Objective:
To describe the safety profile of a booster dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
DTaP-Hep B-PRP-T + OPV vaccine group
DTaP-HB-PRP~T vaccine
0.5 mL, Intramuscular
Oral Polio Vaccine
0.5 mL, Oral
Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
Tritanrix-HepB/Hib™
0.5 mL, Intramuscular
Oral Polio Vaccine
0.5 mL, Oral
Interventions
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DTaP-HB-PRP~T vaccine
0.5 mL, Intramuscular
Tritanrix-HepB/Hib™
0.5 mL, Intramuscular
Oral Polio Vaccine
0.5 mL, Oral
Eligibility Criteria
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Inclusion Criteria
* Participated in the AL203 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
* 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 intramuscular (IM) vaccination
* Serious adverse event related to any vaccination in the AL203 study.
15 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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Manila, , Philippines
Quezon City, , Philippines
Countries
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Related Links
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Related Info
Other Identifiers
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AL205
Identifier Type: -
Identifier Source: org_study_id