NCT00534833

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 15 Months – 18 Months
• Healthy volunteers: Accepted

Summary

The present trial is a follow-up of AL203 study (NCT00343889). 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

Study participants will receive a booster vaccination of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-HB-PRP~T vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Tritanrix-HepB/Hib™	0.5 mL, Intramuscular
BIOLOGICAL	Oral Polio Vaccine	0.5 mL, Oral

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2009-03-01
• First posted: 2007-09-26
• Last updated: 2013-11-21
• Results posted: 2013-11-21

Locations

2 sites across 1 country: Philippines