Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- The antibody titers for each valence of DTaP-IPV-Hep B-PRP-T vaccine (except poliovirus) post-primary and booster vaccination. [ Time Frame: Age 3.5 and 4.5 years after infant and booster vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T.
Participants previously received 3 doses CombAct-Hib™ + Engerix™ B + OPV and a booster dose of CombAct-Hib™ + Oral poliovirus vaccine (OPV) vaccine.
Participants previously received 3 doses DTaP IPV Hep B PRP-T; a dose of Engerix™ B at birth, and a booster dose of DTaP IPV Hep B PRP-T vaccine.
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.