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MenABCWY Vaccine for Meningococcal Meningitis
Study Summary
This trial will test a new vaccine to see if it is safe and effective against meningococcal disease, which is a serious infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 520 Patients • NCT03587207Trial Design
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Who is running the clinical trial?
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- I am between 11 and 14 years old.You or your legal guardian have given written or thumbprint consent before any study procedure is performed.Before any study-specific procedures are done, you must give written permission to participate (if you're able to do so).You have used birth control for at least 30 days before getting the first vaccine.Female participants of childbearing age need to use effective birth control for 30 days before and after each vaccination. They will also need to provide urine samples to confirm they are not pregnant before each vaccination.I am [your height in inches] inches tall.I am a woman who cannot become pregnant due to surgery or being before puberty.You are determined to be in good health by a doctor's evaluation before starting the study.I weigh... pounds.Women must have a negative pregnancy test on the day they receive the vaccine.You and your parent/legal representative are willing and able to follow the study's rules and requirements, as determined by the investigator.
- Group 1: ABCWY-24 Group
- Group 2: ABCWY-48 Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are people with the relevant illness able to sign up for this trial at this time?
"That is accurate. The listing on clinicaltrials.gov says that the trial is still looking for patients. This trial was originally posted on December 29th, 2021 and was last edited on October 20th, 2022. They are looking for 300 individuals total at 24 different sites."
In this particular study, are the participants restricted to a certain age group?
"This trial is only for adolescents aged 11 to 14. There are 13 other clinical trials for minors and 24 for elderly patients."
At how many distinct research sites is this trial being conducted?
"There are two dozen hospitals running this study nationwide. A few examples of locations where you can enroll are Missoula, Endwell and Charlotte. You can pick the location nearest to you to help reduce travel time and costs."
What are the odds of contracting complications from the MenABCWY vaccine?
"While there is some evidence of the MenABCWY vaccine's safety, it has not been proven effective yet and thus receives a score of 2."
Would I be able to participate in this clinical study?
"This trial is looking for 300 participants between the ages of 11 and 14 who have meningitis or meningococcal. The following criteria must also be met: Participants or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol., Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure., Written informed assent obtained from the participant (if applicable) prior"
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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