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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00137917

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 II

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Publications indexed to this study:

Boutriau D, Poolman J, Borrow R, Findlow J, Domingo JD, Puig-Barbera J, Baldo JM, Planelles V, Jubert A, Colomer J, Gil A, Levie K, Kervyn AD, Weynants V, Dominguez F, Barbera R, Sotolongo F. Immunogenicity and safety of three doses of a bivalent (B:4:p1.19,15 and B:4:p1.7-2,4) meningococcal outer membrane vesicle vaccine in healthy adolescents. Clin Vaccine Immunol. 2007 Jan;14(1):65-73. Epub 2006 Oct 25.

Study ID Numbers:	710158/002
Study First Received:	August 26, 2005
Last Updated:	November 22, 2006
ClinicalTrials.gov Identifier:	NCT00137917
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by GlaxoSmithKline:

Prophylaxis meningococcal serogroup B disease

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases

Healthy
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on January 14, 2009