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Conjugate Vaccine

Meningococcal Conjugate 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 before and after the vaccination at 15 months of age for subgroup 1b and 2b
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of two vaccines given to infants and toddlers.

Eligible Conditions
  • Meningococcal Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after the vaccination at 15 months of age for subgroup 1b and 2b
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after the vaccination at 15 months of age for subgroup 1b and 2b 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 above predefined thresholds against meningococcal serogroups A, C, Y, and W (Subgroup 1a and 2a)
Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W (group 1 and 2)
Secondary outcome measures
Antibody against meningococcal serogroups A, C, Y, and W
Antibody concentrations above predefined threshold against diphteria and tetanus
Antibody concentrations above predefined threshold against pertussis (PT, FHA, PRN, FIM)
+16 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 1bExperimental Treatment8 Interventions
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
Group II: Group 1aExperimental Treatment7 Interventions
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Group III: Group 2aActive Control7 Interventions
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
Group IV: Group 2bActive Control8 Interventions
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MenACYW conjugate vaccine
2018
Completed Phase 3
~5580
DTaP-IPV//Hib vaccine
2018
Completed Phase 3
~2640
Hepatitis A vaccine
2008
Completed Phase 4
~71400
Hepatitis B vaccine
1999
Completed Phase 4
~118570
Varicella vaccine
2019
Completed Phase 3
~3980
Pentavalent rotavirus vaccine
2018
Completed Phase 3
~2640
Measles, mumps, rubella (MMR) vaccine
2018
Completed Phase 3
~2640
Pneumococcal 13-valent conjugate vaccine
2019
Completed Phase 4
~5430

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
404 Previous Clinical Trials
6,054,910 Total Patients Enrolled
Medical DirectorStudy DirectorSanofi Pasteur, a Sanofi Company
2,769 Previous Clinical Trials
8,059,563 Total Patients Enrolled

Media Library

MenACYW-135 conjugate vaccine (Conjugate Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03537508 — Phase 3
Meningococcal Infection Research Study Groups: Group 1a, Group 1b, Group 2a, Group 2b
Meningococcal Infection Clinical Trial 2023: MenACYW-135 conjugate vaccine Highlights & Side Effects. Trial Name: NCT03537508 — Phase 3
MenACYW-135 conjugate vaccine (Conjugate Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03537508 — Phase 3

Frequently Asked Questions

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

Are people aged 60+ being sought out for this particular clinical research?

"The age requirements for this study are that participants must be younger than 89 days old and older than 42 days old."

Answered by AI

Can new patients still join this research project?

"This clinical trial is no longer recruiting patients. The information for this study was first posted on 4/25/2018 and most recently updated on 9/14/2022. There are other opportunities available, with 13 trials actively searching for participants with meningococcal infections and 86 trials for MenACYW conjugate vaccine currently looking for patients."

Answered by AI

What is MenACYW conjugate vaccine used to prevent?

"The MenACYW conjugate vaccine is the most common prescribed medication for mumps. However, this drug can also be used to treat poliomyelitis, human poliovirus 1, and gastroenteritis."

Answered by AI

What are the main goals that researchers are hoping to achieve with this experiment?

"The aim of this study, which will follow patients for D0 and 30 days after the fourth meningococcal vaccination, is to have participants generate Antibodies at a titer of ≥ 1:8 against common meningococcal serogroups. Additionally, the study hopes to see positive outcomes in regards to secondary measures including established percentage of participants with antibody concentrations above MMR vaccine thresholds, PRP antibodies within acceptable ranges as determined by standard assays, and finally a predefined percentage of participants achieving an antibody titer of ≥1:8."

Answered by AI

Is the MenACYW conjugate vaccine unique among other vaccines?

"The MenACYW conjugate vaccine was first studied in 2006 at Duke University Medical Center. Out of the 883 completed clinical trials, 86 are still ongoing with many taking place in Austin, Texas."

Answered by AI

Could I please inquire about the requirements to join this experiment?

"The team conducting this study is seeking 2628 individuals who have meningococcal infections and are between 42 days to 89 days old."

Answered by AI

In how many different locations is this research being conducted?

"36 different medical facilities are participating in this research project, these include locations like Investigational Site Number: 8400059 in Austin, Charleston's Investigational Site Number: 8400005, and Spring Hill's Investigational Site Number: 8400064."

Answered by AI

How many test subjects are included in this experiment?

"This study is now closed to new participants. It was originally posted on April 25th, 2018 and last updated on September 14th, 2022. There are currently 13 other clinical trials enrolling patients with meningococcal infections and 86 for MenACYW conjugate vaccine."

Answered by AI

Could you please explain the side effects of MenACYW conjugate vaccine?

"There is some data from earlier trials to support the efficacy of MenACYW conjugate vaccine, and it has undergone multiple rounds of testing for safety. Therefore, we have given it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Investigational Site Number :8400076
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
~381 spots leftby Mar 2025