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Cancer Vaccine

Pentavalent Meningococcal Vaccine for Meningococcal Disease

Phase 1 & 2
Recruiting
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 to 25 years or 10 to 17 years on the day of inclusion
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 12 months
Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of a new meningococcal vaccine in adults and teens. It will last up to 12 months.

Who is the study for?
This trial is for healthy individuals aged 10-25 who may or may not have had a MenACWY vaccine at least 4 years ago. They must pass a medical evaluation including history and physical exam to participate.Check my eligibility
What is being tested?
The study tests the safety and immune response of an investigational pentavalent meningococcal ABCYW vaccine compared with other vaccines and placebo in adults and adolescents over up to 12 months.See study design
What are the potential side effects?
Potential side effects could include pain at the injection site, fever, fatigue, headache, muscle pain, chills, nausea or joint pain similar to other vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 10-25 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 12 months 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) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the last dose in adolescent participants
Number of participants with immediate adverse events (AEs)
+12 more
Secondary outcome measures
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adult participants
+20 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Group 6: Sanofi MenBExperimental Treatment2 Interventions
Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo
Group II: Group 2: MenPenta Formulation 2Experimental Treatment2 Interventions
Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Group III: Group 1: MenPenta Formulation 1Experimental Treatment2 Interventions
Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Group IV: Group 3: Bexsero® + Menveo®Active Control2 Interventions
Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine
Group V: Group 5: MenQuadfi®Active Control2 Interventions
Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
Group VI: Group 4: Trumenba® + Menveo®Active Control2 Interventions
Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meningococcal group B vaccine
2018
Completed Phase 3
~790
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,090,861 Total Patients Enrolled
5 Trials studying Meningococcal Disease
65,551 Patients Enrolled for Meningococcal Disease
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,018,718 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment available for this trial at present?

"Affirmative. The clinicaltrials.gov database indicates that, as of 11/8/2023, this study is searching for participants. It was initially posted on 10/31/2023 and is looking to recruit 1120 patients from 13 different sites."

Answered by AI

How many participants are being admitted into this medical experiment?

"Verified. According to clinicaltrials.gov, the trial is actively recruiting 1120 participants across 13 sites since its posting on October 31st 2023 and subsequent update November 8th 2023."

Answered by AI

How many geographic areas are offering this trial?

"Currently, 13 medical centres are running the trial. These locations range from Canoga Park to DeLand and Fair Oaks; thus, it is important for patients to pick a clinic nearby in order to minimize their travel burden when participating."

Answered by AI

Does this research permit individuals over the age of 50 to participate?

"This clinical trial has specified the age range of its participants to be between 10 and 25 years old. Moreover, there are 71 trials for individuals younger than 18 while 411 cater to patients older than 65."

Answered by AI

Who else is applying?

What site did they apply to?
Smart Cures Clinical Research Site Number : 8400072
Velocity Clinical Research-Washington DC Site Number : 8400102
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
2023. "Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128733.
All > Albuquerque > Nashville
~747 spots leftby May 2025
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