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drugset / Trial / NCT00317109

Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

NCT00317109 ↗

Phase 3 Completed 168 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start
2006-04-19
Primary completion
2007-05-01
Completion
2007-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN Vaccine — Intramuscular
Subject Mencevax ACW Vaccine — Subcutaneous
Subject Tritanrix-HepB Vaccine — Intramuscular

Indications

meningococcal infection