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

NCT02285777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2018-09-24

Study results available
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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

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)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2015-03-26
Completion
2015-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02285777 on ClinicalTrials.gov