NCT00514709

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,843 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

Summary

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).

Detailed description

This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP\~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP\~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-HB PRP~T Combined Vaccine	0.5 mL, Intramuscular (IM)
BIOLOGICAL	DTaP-HB-PRP~T vaccine	0.5 mL, IM
BIOLOGICAL	Oral Polio Vaccine	Oral co-administered with study vaccine.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-12-01
• Completion: 2009-04-01
• First posted: 2007-08-10
• Last updated: 2016-08-02
• Results posted: 2013-11-14

Locations

7 sites across 1 country: Philippines