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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

Pivotal Trial

Summary

This trial is testing two vaccines in healthy adolescents and young adults. One vaccine is already approved, and the other is new. Both vaccines aim to protect against bacteria that cause serious infections by teaching the immune system to fight them off.

Eligible Conditions

Meningococcal Disease

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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