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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137917
Other study ID # 710158/002
Secondary ID
Status Completed
Phase Phase 2
First received August 26, 2005
Last updated September 15, 2016
Start date July 2002
Est. completion date June 2003

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 478
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 18 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Meningococcal serogroup B vaccine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only) No
Secondary After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30) No
Secondary Serious adverse events [SAEs] (whole study) No
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