Hepatitis B Clinical Trial
Official title:
Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722)
and booster vaccination in Study A3L27 (NCT01444781).
Study Objective:
- To describe the long-term antibody 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+Prevenar™ (PCV7)
+Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of
age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix
hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.
Observational Objectives:
- To describe the long-term antibody persistence by group and by stratification on the
age at inclusion of the A3L27 booster study.
- To describe the effect of one additional oral dose of stand alone poliovirus isotypes
1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes
(4 vs 5 doses of poliovirus administered).
No investigational vaccine will be administered in the study. Subjects who were previously
randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be
invited to take part in this study.
Any serious adverse events (SAEs) related to the vaccines administered during the preceding
trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the
trial.
No vaccine will be administered as part of this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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