NCT02285777

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal ABCWY	One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
BIOLOGICAL	Placebo	One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-03-26
• Completion: 2015-06-11
• First posted: 2014-11-07
• Last updated: 2018-09-24
• Results posted: 2017-12-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study