NCT00454987

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine

Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals' Hib & Meningococcal C Vaccine (Menitorix™) 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix™ at 2, 3, 4 Months of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 24 Months – 64 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life. This protocol posting deals with objectives \& outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase \& booster phase at 12 to 15 months are provided below: https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)

Detailed description

This multicentre \& multicountry study is open and has 2 study groups at Visits 1 and 3 (HibMenC and LicMenC). An additional control group in the UK at the time of the second year follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be further randomized. The subjects of group NoBoost will not be randomized. All subjects at the UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a Hib catch-up vaccine (Menitorix™) at the same visit. Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses: at 12, 24 \& 48 months after the booster vaccination. Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects will be enrolled in this study (group NoBoost).

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis
• Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Menitorix	Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.
BIOLOGICAL	Infanrix IPV	Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

Timeline

• Start date: 2007-05-16
• Primary completion: 2007-10-12
• Completion: 2007-10-12
• First posted: 2007-04-02
• Last updated: 2020-06-16
• Results posted: 2015-12-16

Locations

9 sites across 2 countries: Poland, United Kingdom