Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Meningococcal

Treatments

Biological: MenC-TT

Biological: Hib-MenC-TT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135564

711202/008

Details and patient eligibility

About

The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.

Full description

The study is an extension of the primary vaccination study 711202/001 (MenC-TT-001). It comprises 5 groups: 4 parallel groups of toddlers vaccinated in study 711202/001 (group vaccinated with Meningitec™ is control group 1) and 1 group of naive subjects (no previous vaccination against MenC disease, control group 2). All subjects receive 1/5th dose Mencevax™ ACWY and a concomitant dose of Infanrix hexa®. 2 blood samples: prior to and 1 month after vaccination.

Enrollment

500 patients

Sex

All

Ages

12 to 15 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment

Exclusion criteria

Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of any neurologic disorders or seizures, of allergic disease/reactions likely to be exacerbated by any component of the vaccines