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Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) for Meningococcal Disease
Study Summary
This trial is testing how well two vaccines work when given together to see if they are safe and cause an immune response.
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.Trial Design
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- The person has been using contraception for the past month in order to avoid becoming pregnant.You or your child have an autoimmune disorder or a weakened immune system.You or your child experience seizures on a regular basis.Are you currently pregnant or breastfeeding?The person giving the consent or assent must have received one dose of the quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior.has agreed to continue using contraception during the entire treatment period and for 2 months after completion of the vaccination series.You are between 16 and 18 years old when you receive your first vaccine.Women who cannot become pregnant may participate in the study. This includes women who have not started their menstrual periods, had their tubes tied, had their uterus or ovaries removed, or have gone through menopause.We got written or thumbprinted consent from the subject or their parents or legal guardians before doing any study-specific procedures.You need to take a pregnancy test before getting the vaccine and it should be negative.We will get written consent from the subject (if applicable) and the subject's parent(s)/LAR(s) before doing any study-specific procedures.Before entering the study, the subjects were determined to be healthy by reviewing their medical history and conducting a clinical examination.Have you or your child ever had an infection called meningococcal?Have you or your child received a meningococcal vaccine before?You and/or your legal representative are willing and able to follow the instructions of the study as directed by the investigator.
- Group 1: MenB+MenACWY Group
- Group 2: MenACWY Group
- Group 3: MenB Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
If a patient is over twenty-five, will they still be able to participate in the research?
"According to the eligibility requirements, this clinical trial is only open to patients that are aged 16 to 18. Out of the 34 trials currently available, 26 are for patients under 18 and 8 are for patients over the age of 65."
Are there any other ongoing or completed research studies looking at the effects of Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)?
"The Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), first studied in 2013 at The Rockefeller University, has had 18393 completed studies thus far. As of now, there are 20 active trials, a number of which are based in Oakland, California."
Are participants still being asked to join this trial?
"Yes, the website clinicaltrials.gov has information indicating that this particular trial is presently looking for patients. Originally, the trial was posted on 8/25/2020, and the most recent update was on 9/30/2022. This trial is looking for a total of 945 participants, which will be recruited from 50 different sites."
What are the estimated benefits of participating in this clinical trial?
"The purpose of this study, which will last for451 days, is to measure the human body's response to the second vaccination of rMenB+OMV NZ. Additionally, the study will observe the immune system's reaction to MenACWY given with or without rMenB+OMV NZ and compare it to the baseline at Day 1/Month 0. This will be done by measuring the Geometric Mean Titers (GMTs) and percentage of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ)."
Are there specific inclusion/exclusion criteria for this study?
"This trial is seeking 945 patients that have contracted meningococcal infections and are between the ages of 16 and 18. It is of utmost importance that applicants meet the following requirements: a negative pregnancy test on the day of vaccination, the ability to comply with the requirements of the protocol, being between the ages of 16 and 18, being male or female, being of non-childbearing potential, not having an autoimmune disorder or deficiency, not having recurring seizures, never having had a meningococcal infection, never having had a meningococcal vaccination, not being pregnant, and not breast feeding."
How many people are chosen to be a part of this experiment?
"Yes, that is correct. The information available on clinicaltrials.gov indicates that this trial is looking for 945 patients at 50 different locations. The trial was first posted on 8/25/2020 and was last updated on 9/30/2022."
Are there any risks associated with Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)?
"This clinical trial is currently in Phase 3, meaning that there is some data supporting the efficacy of the Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid). Additionally, there have been multiple rounds of data supporting the safety of the vaccine, so our team at Power has given it a safety rating of 3."
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