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Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00137917
First received: August 26, 2005
Last updated: November 22, 2006
Last verified: November 2006
History of Changes
  Purpose

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).


Condition Intervention Phase
Meningitis, Meningococcal, Serogroup B
 Biological: Meningococcal serogroup B vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Primary Vaccination Study to Evaluate Immunogenicity, Safety & Reactogenicity of 3 Doses of GSK Biologicals/Finlay’s Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Mth or 0-1-6 Mth Schedule to Healthy Subjects Aged 12-18 Yrs

Resource links provided by NLM:

MedlinePlus related topics: Meningitis
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed

Secondary Outcome Measures:
  • For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
  • After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
  • Serious adverse events [SAEs] (whole study)

Estimated Enrollment: 450
Study Start Date: July 2002
Detailed Description:

The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
  • Female subjects must be of non-childbearing potential.

Exclusion Criteria:

  • Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any neurologic disorders or seizures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137917

Locations
Spain
Valencia, Spain
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: NCT00137917     History of Changes
Other Study ID Numbers: 710158/002
Study First Received: August 26, 2005
Last Updated: November 22, 2006
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by GlaxoSmithKline:
Prophylaxis meningococcal serogroup B disease

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

ClinicalTrials.gov processed this record on May 19, 2013