NCT00317109

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

Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Months – 18 Months
• Healthy volunteers: Accepted

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.

Detailed description

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject. Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Tritanrix™- HepB	One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
BIOLOGICAL	Hiberix™	One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
BIOLOGICAL	Mencevax™ ACW	One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

Timeline

• Start date: 2006-04-19
• Primary completion: 2007-05-01
• Completion: 2007-05-17
• First posted: 2006-04-24
• Last updated: 2018-06-06
• Results posted: 2017-03-01

Locations

3 sites across 1 country: South Africa