drugset / Trial / NCT01983540

Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination

NCT01983540

Phase 3 Completed 558 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

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).

Timeline

Start
2013-10
Primary completion
2015-06
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Background DTaP-IPV-Hep B-PRP~T Unknown
Background Infanrix hexa Vaccine
Background Prevnar 13 Vaccine
Background Rotarix Vaccine