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

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ClinicalTrials.gov Identifier: NCT00135564
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Infections, Meningococcal Biological: MenC-TT Biological: Hib-MenC-TT Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2003
Primary Completion Date : July 2003
Study Completion Date : July 2003





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


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135564


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

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
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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