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Clinical Trial 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.


Clinical Trial Description

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01444781
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date September 2011
Completion date October 2013

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