Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
- Conditions
- ovartis Meningococcal ABCWY conjugate vaccine is intended forprevention of meningitis and septicemia caused by Neisseriameningitidis serogroups A, B, C, W and Y.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-001030-16-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 305
Inclusion Criteria
Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).
Are the trial subjects under 18? yes
Number of subjects for this age range: 291
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
2) History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method