NCT00891176

Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines

Persistence of Antibodies After Full Vaccination Course With GSK Biologicals' Menitorix or MenC Conjugate Vaccine, Co-administered With DTPa or DTPa/Hib Containing Vaccine and Pneumococcal Conjugate Vaccine, in Children up to 6 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 36 Months – 76 Months
• Healthy volunteers: Accepted

Summary

This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437). The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.

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 107005 and will not be further randomized in this study.

Conditions

• Neisseria Meningitidis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	MenitorixTM	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
BIOLOGICAL	Pneumococcal conjugate vaccine GSK1024850A	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
BIOLOGICAL	PrevenarTM	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
BIOLOGICAL	MeningitecTM	Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
BIOLOGICAL	NeisVac-CTM	Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
BIOLOGICAL	InfanrixTM hexa	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
BIOLOGICAL	InfanrixTM penta	Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
BIOLOGICAL	InfanrixTM IPV/Hib	Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
BIOLOGICAL	InfanrixTM IPV	Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study

Timeline

• Start date: 2009-05-14
• Primary completion: 2012-11-21
• Completion: 2012-11-21
• First posted: 2009-05-01
• Last updated: 2018-02-15
• Results posted: 2010-12-23

Locations

28 sites across 3 countries: Germany, Poland, Spain