CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 305 enrolled
Drug / intervention
MenABCWY +2 morebiological
Likely dose
MenABCWY 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02140762
NCT02140762Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

Novartis Vaccines·interventional·Posted May 16, 2014·Updated Sep 12, 2018

In Brief

A Phase 2 clinical trial evaluating MenABCWY, Placebo, and 1 other intervention for Meningococcal Disease. Completed, enrolled 305 participants across 8 sites.

Detailed Summary

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 16, 2014
Enrollment StartMay 1, 2014
Primary CompletionNov 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.1 years ago

Interventions

MenABCWYbiological

Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.

Placeboother

0.5 mL saline solution (IM)

MenACWYbiological

Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.