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Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

NCT03587207 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2020-02-12

Study results available
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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.

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

MenABCWY vaccine

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

BIOLOGICAL

rMenB+OMV NZ (Bexsero) vaccine

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

BIOLOGICAL

MenACWY (Menveo) vaccine

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2018-12-19
Completion
2018-12-19

Countries

  • Czechia

Study Locations

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Entities

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 NCT03587207 on ClinicalTrials.gov