CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 520 enrolled
Drug / intervention
MenABCWY vaccine +2 morebiological
Likely dose
Not stated in 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/NCT03587207
NCT03587207Phase 2Completed

Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone

GlaxoSmithKline·interventional·Posted Jul 16, 2018·Updated Feb 12, 2020

In Brief

A Phase 2 clinical trial evaluating MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine, and 1 other intervention for Meningitis, Meningococcal. Completed, enrolled 520 participants across 1 site.

Detailed Summary

The purpose of the current study is to evaluate whether there is immune interference when MenABCWY \[consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component\] is administered to healthy adolescents and adults following a 2-dose vaccination schedule with MenABCWY administered 2 months apart.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 16, 2018
Enrollment StartJul 9, 2018
Primary CompletionDec 19, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago

Interventions

MenABCWY vaccinebiological

Two doses administered intramuscularly in the deltoid region of the non-dominant arm.

rMenB+OMV NZ (Bexsero) vaccinebiological

Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group, rMenBOMV+ACWY\_D Group and rMenBOMV Group

MenACWY (Menveo) vaccinebiological

Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY\_S Group and rMenBOMV+ACWY\_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group