NCT00322335

Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

Phase III, Open, Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC Compared to a Booster Dose of Infanrix™ Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 & Boosted in Study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 31 Months – 33 Months
• Healthy volunteers: Accepted

Summary

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives \& outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050). The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b- and meningococcal (vaccine)	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
BIOLOGICAL	Infanrix™ penta	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
BIOLOGICAL	Infanrix™ hexa	Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
BIOLOGICAL	Engerix-B	Intramuscular injection into the thigh as a birth dose
BIOLOGICAL	NeisVac-C™	Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
BIOLOGICAL	Infanrix™ IPV/HIB	Intramuscular injection into the thigh as primary vaccination at 4 months of age
BIOLOGICAL	Meningitec™	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-07-01
• Completion: 2010-09-01
• First posted: 2006-05-05
• Last updated: 2016-10-20
• Results posted: 2011-01-14

Locations

12 sites across 1 country: Spain