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Meningococcal Group B Vaccine for Meningitis Prevention
Study Summary
This trial is testing the safety of a new meningitis B vaccine in adults, adolescents, toddlers, and infants. The vaccine will be given either alone or with other routine vaccines. The study will also look at the vaccine's ability to generate 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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I have had Guillain-Barré syndrome in the past.I am not currently detained, in an emergency setting, or hospitalized without my consent.I have had a Neisseria meningitidis infection.I have active tuberculosis.I cannot become pregnant.My child has been vaccinated against meningitis before.I can attend all scheduled visits and follow all trial procedures.I have been vaccinated against meningococcal B disease before.I have a history of neurological disorders or seizures.I don't have a bleeding disorder and haven't taken blood thinners in the last 3 weeks.I have not received any blood products or immune globulins in the last 3 months.- If you are in the US, you must be between 10 and 25 years old. If you are in the EU, you must be between 42 days and 89 days old, or between 12 and 18 months old, or between 10 and 50 years old.
- You and your parent/legal representative must be able to attend all scheduled visits and follow all trial procedures.
- You must have health insurance, as required by local regulations.
- You must be in good health, as determined by medical evaluation.
- If you are a female of childbearing age, you must agree to use an effective form of birth control or abstain from sex during the study. If you are not able to get pregnant, you must be post-menopausal for at least 1 year or surgically sterile. The birth control method should be used starting 4 weeks before the first study intervention and until at least 4 weeks after the last one.My chronic illness may affect my participation in the study.I haven't had vaccines 4 weeks before or plan to get any within 4 weeks after the trial vaccine, except for flu shots.If you are a female, you are either not able to have children or you agree to use effective birth control methods during the study and for four weeks after it ends. If you have a newborn, they must have been born at full term and weigh at least 2.5 kg or have been born prematurely but are medically stable.I have a weak immune system or have been on strong immune-weakening medication recently.I have not taken antibiotics by mouth or injection in the last 3 days.I am at high risk for meningococcal infection due to my health condition or travel plans.I have a low platelet count that prevents me from getting shots in my muscles.My child has had intussusception before.You have had a severe allergic reaction to latex or any of the ingredients in the vaccine(s) used in the trial or to a vaccine that contains the same substances.My infant has received vaccines for common diseases and more than one dose of the hepatitis B vaccine.I am not pregnant or breastfeeding.I am a woman who can have children and have a negative pregnancy test.I am either 42-89 days, 12-18 months, or 10-50 years old.I am between 10 and 25 years old.I am a female adolescent not pregnant or breastfeeding.My baby was born full-term or preterm but is now medically stable.
- Group 1: Stage 4: MenQuadfi vaccine and vaccine comparator
- Group 2: Stage 4: MenB vaccine formulation(s)
- Group 3: Stage 1: vaccine comparator(s)
- Group 4: Stage 2: MenB vaccine formulation(s)
- Group 5: Stage 2: vaccine comparator(s)
- Group 6: Stage 3: Men B vaccine formulation(s)
- Group 7: Stage 3: MenQuadfi vaccine and vaccine comparator
- Group 8: Stage 1: MenB vaccine formulation(s)
- 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
Is this experiment a pioneering endeavor for its field?
"Meningococcal Group B Vaccine MenB was first studied in 2016 by Pharmacyclics LLC. After the initial trial involving 42 participants, it attained Phase 2 drug approval. Presently, 31 trials are underway for this medication across 354 cities and 45 nations throughout the globe."
Are there further opportunities for participants to join this research?
"In accordance with the information found on clinicaltrials.gov, this medical trial is currently searching for participants to enroll. It was initially made available online on March 29th 2021 and most recently updated November 21st 2022."
What condition is the Meningococcal Group B Vaccine MenB most commonly prescribed for?
"Meningococcal Group B Vaccine MenB is a commonly used treatment for pertussis, and can also be employed to manage tetanus, communicable illnesses, as well as meningococcal disease."
What is the primary objective of this medical experiment?
"This medical trial has three primary objectives that will be assessed within a week after vaccination: the antibody titers in the MenB strains before and after each injection, as well as secondary panel of MenB strain antibody titers. All titer measurements are conducted using hSBA technology."
Is there an age cutoff for enrollment in this clinical experiment?
"According to the requirements, individuals who wish to join this research study must be between 42 days and 50 years of age. There are 23 studies for minors and 9 for seniors."
Am I eligible to partake in this medical research?
"To take part in this study, individuals must have received a meningococcal immunisation and be between 42 days old and 50 years of age. A total of 1800 participants will need to be recruited for the experiment's success."
Could you provide an overview of the historical research done pertaining to Meningococcal Group B Vaccine MenB?
"Meningococcal Group B Vaccine MenB was initially studied at Ohio State University Comprehensive Cancer Center in 2016. Since then, 18620 trials have been finished and 31 currently remain active with a high concentration located in Wichita, Kansas."
Could you enumerate the individuals involved in this medical research?
"The sponsor of this trial, Sanofi Pasteur (a part of the larger Sanofi Company), requires a total of 1800 participants to meet its inclusion criteria. Two particular locations are Alliance for Multispecialty Research LLC-Site Number:8400013 in Wichita, Kansas and Investigational Site Number 8400001 in Canoga Park, California."
How many research centers are carrying out this trial?
"This research endeavor is currently recruiting 61 patients from various sites, including Alliance for Multispecialty Research LLC-Site Number:8400013 in Wichita, Investigational Site Number 8400001 in Canoga Park and Investigational Site Number :8400029 in Guntersville."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
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