Study conducted in healthy adolescents to evaluate safety and antibody response after the administration of different schedules of a vaccine produced by GSK Vaccines and Diagnostics compared to GSK Meningococcal group B vaccineand and directed against Meningococcal serogroup A, B, C, Y and W strains.

Phase 1

• Conditions: The current study is designed to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination.; MedDRA version: 19.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002451-15-FI
• Lead Sponsor: GlaxoSmithKline Biologicals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-27
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. Female subjects of childbearing potential must have a negative urine pregnancy test.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1050
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine or Hepatitis A vaccine. Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified