Meningococcal Group B Vaccine MenB for Meningococcal Immunisation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Meningococcal Immunisation
Meningococcal Group B Vaccine MenB - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety of a new meningitis B vaccine in adults, adolescents, toddlers, and infants. The vaccine will be given either alone or with other routine vaccines. The study will also look at the vaccine's ability to generate an immune response.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 4 Secondary · Reporting Duration: Day 01, Day 31, Day 61, Day 91, Day 181, Day 211, Day 366 and Day 396

Day 01 (pre-vaccination)
Antibody titers in the primary panel of MenB strains before primary vaccination
Day 30
Antibody titers against each of Men A, C, W, and Y strains
Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only)
Day 396
Antibody titers in the primary panel of MenB strains after each vaccination
Day 30 (post-vaccination)
Antibody titers in the primary panel of MenB strains after primary vaccination
Day 396
Antibody titers in the primary panel of MenB strains (stage 2 only)
Day 07
Number of participants with out-of-range biological test results
Month 6
Number of participants with medically attended adverse events (MAAE)s
Number of participants with serious adverse events (SAEs)
Day 30
Number of participants with unsolicited AEs
Within 30 minutes after vaccination
Number of participants with immediate adverse events (AEs)
Day 7
Number of participants with solicited injection site reactions or systemic reactions

Trial Safety

Trial Design

8 Treatment Groups

Stage 1: vaccine comparator(s)
1 of 8
Stage 2: vaccine comparator(s)
1 of 8
Stage 4: MenQuadfi vaccine and vaccine comparator
1 of 8
Stage 3: MenQuadfi vaccine and vaccine comparator
1 of 8
Stage 1: MenB vaccine formulation(s)
1 of 8
Stage 4: MenB vaccine formulation(s)
1 of 8
Stage 2: MenB vaccine formulation(s)
1 of 8
Stage 3: Men B vaccine formulation(s)
1 of 8

Active Control

Experimental Treatment

1800 Total Participants · 8 Treatment Groups

Primary Treatment: Meningococcal Group B Vaccine MenB · Has Placebo Group · Phase 1 & 2

Stage 1: MenB vaccine formulation(s)Experimental Group · 2 Interventions: Meningococcal Group B Vaccine MenB, Placebo · Intervention Types: Drug, Drug
Stage 4: MenB vaccine formulation(s)Experimental Group · 2 Interventions: Meningococcal Group B Vaccine MenB, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine · Intervention Types: Drug, Drug
Stage 2: MenB vaccine formulation(s)Experimental Group · 3 Interventions: Meningococcal Group B Vaccine MenB, Placebo, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine · Intervention Types: Drug, Drug, Drug
Stage 3: Men B vaccine formulation(s)Experimental Group · 2 Interventions: Meningococcal Group B Vaccine MenB, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine · Intervention Types: Drug, Drug
Stage 1: vaccine comparator(s)ActiveComparator Group · 3 Interventions: Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Placebo · Intervention Types: Drug, Drug, Drug
Stage 2: vaccine comparator(s)ActiveComparator Group · 3 Interventions: Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Placebo · Intervention Types: Drug, Drug, Drug
Stage 4: MenQuadfi vaccine and vaccine comparatorActiveComparator Group · 2 Interventions: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine · Intervention Types: Drug, Drug
Stage 3: MenQuadfi vaccine and vaccine comparatorActiveComparator Group · 2 Interventions: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Neisseria meningitidis group A capsular polysaccharide tetanus toxoid conjugate antigen
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 01, day 31, day 61, day 91, day 181, day 211, day 366 and day 396

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
380 Previous Clinical Trials
4,957,418 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
787 Previous Clinical Trials
1,581,312 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a female participant of childbearing potential who is not pregnant.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.