Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Completed · Phase 2 · Has a placebo group
Conditions studied: Meningococcal Disease
In brief
This is extension of the V102\_16 study (NCT02140762). V102\_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102\_16 study will be invited at the time of their last study visit to participate in this extension study.
Key facts
- Study ID
- NCT02285777
- Run by
- GlaxoSmithKline
- People needed
- 189
- Starts
- 2014-12-01
- Expected to finish
- 2015-06-11
- Last updated by the study team
- 2018-09-24
Who can join
Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
- History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.
Where it is running
- GSK Investigational Site — Huntsville, Alabama, United States
- GSK Investigational Site — Jonesboro, Arkansas, United States
- GSK Investigational Site — Melbourne, Florida, United States
- GSK Investigational Site — Newton, Kansas, United States
- GSK Investigational Site — Wichita, Kansas, United States
- GSK Investigational Site — Louisville, Kentucky, United States
- GSK Investigational Site — Omaha, Nebraska, United States
- GSK Investigational Site — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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