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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135564
First received: August 25, 2005
Last updated: September 15, 2016
Last verified: September 2016
  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
Infections, Meningococcal
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 Months 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)

Enrollment: 500
Study Start Date: January 2003
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
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   (Child)
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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 711202/008
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 711202/008
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 711202/008
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 711202/008
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 711202/008
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 711202/008
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00135564     History of Changes
Other Study ID Numbers: 711202/008 
Study First Received: August 25, 2005
Last Updated: September 15, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on December 02, 2016