Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents.

• Conditions: Prophylaxis against invasive disease strains of N. meningitidis serogroup B.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-000979-27-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-07
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

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: 300
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.
• 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