NCT00359983

Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 22 Months – 60 Months
• Healthy volunteers: Accepted

Summary

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129). This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Detailed description

In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study. This Protocol Posting has been updated following Protocol amendment 3, September 2009.

Conditions

• Neisseria Meningitidis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	MenHibrix (Hib-MenCY-TT)	First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
BIOLOGICAL	Hib conjugate vaccine (ActHIB)	First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-11-01
• Completion: 2011-05-01
• First posted: 2006-08-03
• Last updated: 2016-12-16
• Results posted: 2012-07-20

Locations

21 sites across 1 country: United States