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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135564
First received: August 25, 2005
Last updated: November 23, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Meningitis, Haemophilus
Biological: MenC-TT
Biological: Hib-MenC-TT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluate the Persistence and Immune Memory Induced by a Primary Vaccination Course With GSK Biologicals’ MenC-TT (1 Formulation) & GSK Biologicals’ Hib-MenC-TT (2 Formulations) or Meningitec™ in Healthy Toddlers Aged 12-15 Mths Primed in Study 711202/001

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups

Secondary Outcome Measures:
  • Prior to dose 1, 1 m post doses 2, 3: anti-PRP
  • Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN
  • Solicited (days [d] 0–7), unsolicited (up to 30 d) adverse events (AEs) after each dose
  • Serious adverse events (SAEs)

Estimated Enrollment: 500
Study Start Date: January 2003
Detailed 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 "

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135564

Locations
Germany
Mainz, Germany
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00135564     History of Changes
Other Study ID Numbers: 711202/008
Study First Received: August 25, 2005
Last Updated: November 23, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Prophylaxis meningococcal serogroup C disease, Hib diseases
Haemophilus Influenzae type b/Meningococcal (vaccine)

Additional relevant MeSH terms:
Meningitis
Meningitis, Haemophilus
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Haemophilus Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014