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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014