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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137917
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Infections, Meningococcal Biological: Meningococcal serogroup B vaccine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Primary Vaccination Study to Evaluate Immunogenicity, Safety and Reactogenicity of 3 Doses of GSK Biologicals/Finlay's Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Month or 0-1-6 Month Schedule to Healthy Subjects Aged 12-18 Years
Study Start Date : July 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

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

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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): NCT00137917


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

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 710158/002
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: 710158/002
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: 710158/002
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 710158/002
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 710158/002
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00137917    
Other Study ID Numbers: 710158/002
First Posted: August 30, 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:
Prophylaxis meningococcal serogroup B disease
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections