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Vaccine

Pneumococcal 13-valent Conjugate Vaccine for Meningococcal Infection (MET41 Trial)

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 within 30 minutes post-any vaccination
Awards & highlights

MET41 Trial Summary

This trial will study the safety of a new vaccine given with routine childhood vaccines.

Eligible Conditions
  • Meningococcal Infection

MET41 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes post-any vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes post-any vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Number of Participants With Medically Attended Adverse Event (MAAEs)
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
+3 more

MET41 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: MenACYW Conjugate VaccineExperimental Treatment7 Interventions
Healthy infants aged greater than equal to (>=) 42 to less than equal to (<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
Group II: Group 2: MENVEO®Active Control7 Interventions
Healthy infants aged >= 42 to <= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
2018
Completed Phase 3
~2800
Pneumococcal 13-valent Conjugate Vaccine
2019
Completed Phase 4
~4440
Hepatitis B Vaccine
2018
Completed Phase 4
~5230
Measles, Mumps, and Rubella Virus Vaccine
2018
Completed Phase 3
~2800
Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
2018
Completed Phase 3
~2800
Rotavirus Vaccine
2018
Completed Phase 3
~3380
Varicella Virus Vaccine
2018
Completed Phase 3
~2800

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
406 Previous Clinical Trials
6,088,182 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
857 Previous Clinical Trials
2,016,489 Total Patients Enrolled

Frequently Asked Questions

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

How do I sign up for this research project?

"The aim of this clinical trial is to study meningococcal infection in healthy volunteers. To be eligible, participants must be between 42 days and 89 days old. So far, 2799 people have signed up for the study."

Answered by AI

What maladies has the Pneumococcal 13-valent Conjugate Vaccine been shown to be affective against?

"Pneumococcal 13-valent Conjugate Vaccine is not only an effective treatment for gastroenteritis, but also mumps, viral hepatitis b, and pertussis."

Answered by AI

At how many different sites is this trial being conducted?

"This particular clinical trial is being conducted at Investigational Site Number 8400060 in Lincoln, Nebraska as well as a hundred other locations including Investigational Site Number 8400053 in Salt Lake City, Utah and Investigational Site Number 8400044 in Bardstown, Kentucky."

Answered by AI

Can new patients still enroll in this research project?

"Unfortunately, this clinical trial is not recruiting patients at the moment. The listing was created on September 17th, 2018 and updated September 14th, 2022. However, there are 13 other trials for meningococcal infection (healthy volunteers) and 71 trials for Pneumococcal 13-valent Conjugate Vaccine that are currently looking for participants."

Answered by AI

How many human subjects are participating in this experiment?

"As of 9/14/2022, this study is no longer recruiting participants. It was initially posted on 9/17/2018. However, there are currently 13 clinical trials for meningococcal infection (healthy volunteers) and 71 trials for Pneumococcal 13-valent Conjugate Vaccine that are actively enrolling patients."

Answered by AI

Are there any risks associated with Pneumococcal 13-valent Conjugate Vaccine?

"Pneumococcal 13-valent Conjugate Vaccine is safe according to our team's estimation."

Answered by AI

Will elderly patients be accepted into this experimental program?

"This clinical trial's age requirements for enrollment state that participants must be between 42 and 89 days old."

Answered by AI

Is the Pneumococcal 13-valent Conjugate Vaccine new?

"The Pneumococcal 13-valent Conjugate Vaccine was first studied in 2006 at Duke University Medical Center. So far, there have been a total of 686 completed trials. There are presently 71 live clinical trials, with many of these trials actively recruiting patients in Lincoln, Nebraska."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Other
Florida
California
How old are they?
18 - 65
What site did they apply to?
Investigational Site Number 8400051
Investigational Site Number 8400018
Investigational Site Number 8400058
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

The trial inf is misleading. I thought it was recruiting adults in Lincoln, Nebraska. After answering some questions it appears to be for babies in California.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
2018. "Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03673462.
~425 spots leftby Apr 2025
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