NCT01105559

Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine

Antibody Persistence in Healthy South African Children After Primary Series and Booster Vaccination With an Investigational (DTaP-IPV-Hep B-PRP-T) or Control Vaccines

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 455 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 41 Months – 43 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336). Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months

Detailed description

All participants must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336). Participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.

Conditions

• Diphtheria
• Tetanus
• Whooping Cough
• Hepatitis B
• Poliomyelitis

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2010-04-16
• Last updated: 2011-12-13

Locations

2 sites across 1 country: South Africa