Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 10 - 19 |
| Updated: | 9/26/2018 |
| Start Date: | December 1, 2014 |
| End Date: | June 11, 2015 |
A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
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.
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.
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).
Exclusion Criteria:
- 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.
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