Who is sponsoring NCT00514709?

NCT00514709 is sponsored by Sanofi Pasteur, a Sanofi Company.

What condition does NCT00514709 study?

NCT00514709 studies Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza.

What drugs are being tested in NCT00514709?

Interventions: DTaP-HB PRP~T Combined Vaccine, DTaP-HB-PRP~T vaccine, Oral Polio Vaccine.

What is the status of NCT00514709?

NCT00514709 is currently COMPLETED.

Last reviewed 2016-07-05 · How we verify

Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth

NCT00514709 Phase 3 COMPLETED Results posted

DTaP-HB-PRP\~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. 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).

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	1843
Start date	2007-09
Completion	2009-04

Conditions

Diphtheria
Tetanus
Pertussis
Hepatitis B
Influenza

Interventions

DTaP-HB PRP~T Combined Vaccine
DTaP-HB-PRP~T vaccine
Oral Polio Vaccine

Primary outcomes

Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) — Day 0 (pre-vaccination) and Day 28 post-booster vaccination
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.

Countries

Philippines