NCT00303316

Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants

Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 510 Days – 578 Days
• Healthy volunteers: Accepted

Summary

This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series. Primary Objective: To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity. Secondary objective: To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV//PRP~T combined vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV//PRP~T combined vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-04-01
• Completion: 2007-09-01
• First posted: 2006-03-16
• Last updated: 2013-02-22
• Results posted: 2013-02-22

Locations

1 site across 1 country: Argentina