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Conjugate Vaccine

Meningococcal Vaccine for Meningococcal Disease

Phase 3
Waitlist Available
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after the first dose of meningococcal vaccine
Awards & highlights

Study Summary

This trial is testing whether a new vaccine is non-inferior to the current standard vaccine for infants and toddlers. It is also looking at the antibody response to the new vaccine and comparing it to the current standard.

Who is the study for?
This trial is for healthy infants and toddlers aged 6 to 7 months or 17 to 19 months who've had their routine vaccines. They must be able to attend all visits and follow procedures. Kids can't join if they've been in other vaccine trials recently, received certain vaccines too close to the study start, have a history of meningococcal disease, severe allergies, immune problems, blood disorders, or are at high risk for infection.Check my eligibility
What is being tested?
The study tests whether a new Meningococcal Conjugate Vaccine (MenACYW) is as good as an existing one (MENVEO®) when given with routine pediatric shots. It looks at the body's defense response after two doses in young kids by measuring antibodies against meningitis-causing bacteria.See study design
What are the potential side effects?
Possible side effects include reactions where the shot was given like pain or swelling, fever, irritability, sleepiness and loss of appetite. There might also be rare allergic reactions. The exact side effects will be monitored closely during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after the second dose of meningococcal vaccine
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after the second dose of meningococcal vaccine for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibody titers against meningococcal serogroups A, C, Y, and W
Secondary outcome measures
Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the first dose of meningococcal vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the second dose of meningococcal vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W 6 months after the first dose of meningococcal vaccine
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Group II: Group 1Experimental Treatment9 Interventions
MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group III: Group 2Active Control9 Interventions
MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group IV: Group 4Active Control1 Intervention
Menactra® at 17 to 19 months of age and 20 to 23 months of age
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
2018
Completed Phase 3
~960
Haemophilus b Conjugate Vaccine
2019
Completed Phase 3
~2010
Pneumococcal 13-valent Conjugate Vaccine
2019
Completed Phase 4
~4440
Rotavirus Vaccine, Live, Oral, Pentavalent
2020
Completed Phase 3
~3380
Hepatitis B Vaccine
2018
Completed Phase 4
~5230
Measles, Mumps, and Rubella Virus Vaccine Live
2020
Completed Phase 3
~2330
Varicella Virus Vaccine Live
2020
Completed Phase 3
~2390
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
2018
Completed Phase 3
~960
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
2018
Completed Phase 3
~960

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
404 Previous Clinical Trials
6,056,595 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
857 Previous Clinical Trials
2,018,003 Total Patients Enrolled

Media Library

MenACYW conjugate vaccine (Conjugate Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03691610 — Phase 3
Meningococcal Infection Research Study Groups: Group 2, Group 4, Group 1, Group 3
Meningococcal Infection Clinical Trial 2023: MenACYW conjugate vaccine Highlights & Side Effects. Trial Name: NCT03691610 — Phase 3
MenACYW conjugate vaccine (Conjugate Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03691610 — Phase 3
Meningococcal Infection Patient Testimony for trial: Trial Name: NCT03691610 — Phase 3

Frequently Asked Questions

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

Will this research be conducted with a subject pool of exclusively young adults?

"The lower age limit for this clinical trial is 6 months old and the maximum age is 19 months."

Answered by AI

Are there other instances of a Hepatitis B Vaccine being tested in a clinical setting?

"The first clinical study for the Hepatitis b Vaccine took place in 2006 at Duke University Medical Center. As of now, 725 trials have been completed with 79 more currently active. A high concentration of these active trials are located in Miami, Idaho."

Answered by AI

What are the primary objectives of the Hepatitis B Vaccine?

"By receiving the Hepatitis b Vaccine, patients can gain protection from developing gastroenteritis, mumps, and viral hepatitis b."

Answered by AI

Has the Hepatitis B Vaccine received FDA backing?

"There is some evidence to support the efficacy of the Hepatitis b Vaccine, as this is a Phase 3 trial. Furthermore, it has received a safety score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Florida
New York
Other
Texas
How old are they?
65+
What site did they apply to?
Investigational Site Number 8400029
Investigational Site Number 8400076
Investigational Site Number :8400073
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

It said in the NY area not CA.
PatientReceived 1 prior treatment
~148 spots leftby Mar 2025