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Cancer Vaccine

rMenB+OMV NZ vaccine for Meningococcal Disease

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., day 211 for menb_0_2_6 group [3 dose schedule], menb_0_6 group and abcwy_pooled group)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine may help prevent meningitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., day 211 for menb_0_2_6 group [3 dose schedule], menb_0_6 group and abcwy_pooled group)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., day 211 for menb_0_2_6 group [3 dose schedule], menb_0_6 group and abcwy_pooled group) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY
Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration
+16 more
Secondary outcome measures
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
+15 more

Side effects data

From 2022 Phase 4 trial • 1021 Patients • NCT03493919
1%
Depressed level of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
MenACWY 2 Group
rMenB+OMV NZ Group
MenACWY 3 Group
MenACWY 1 Group

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: MenB_0_6 GroupExperimental Treatment3 Interventions
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.
Group II: MenB_0_2_6 GroupExperimental Treatment2 Interventions
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Group III: ABCWY_PooledExperimental Treatment3 Interventions
Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding. To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Group IV: ABCWY-3 GroupExperimental Treatment2 Interventions
Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Group V: ABCWY-2 GroupExperimental Treatment2 Interventions
Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Group VI: ABCWY-1 GroupExperimental Treatment2 Interventions
Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Group VII: ACWY GroupActive Control3 Interventions
Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MenABCWY-1
2020
Completed Phase 3
~3660
MenABCWY-2
2020
Completed Phase 3
~3660
MenABCWY-3
2020
Completed Phase 3
~3660
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
2020
Completed Phase 4
~4680
Placebo
1995
Completed Phase 3
~2670
rMenB+OMV NZ vaccine
2020
Completed Phase 4
~4680

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,065,801 Total Patients Enrolled
11 Trials studying Meningococcal Disease
7,724 Patients Enrolled for Meningococcal Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
2020. "Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502693.
~784 spots leftby Apr 2025
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