drugset / Trial / NCT01444781

Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

NCT01444781

Phase 3 Completed 1106 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupSingle-blindPrevention

Summary

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: * To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose * To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. * To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Timeline

Start
2011-09
Primary completion
2013-04
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Infanrix hexa Vaccine 0.5 ml Intramuscular
Subject Prevnar 13 Vaccine 0.5 ml Intramuscular