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Meningococcal Conjugate Vaccine for Meningococcal Disease
Study Summary
This trial will compare the safety and effectiveness of two vaccines given to infants and toddlers.
- Meningococcal Infection
Timeline
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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Who is running the clinical trial?
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- You have had Guillain-Barré syndrome in the past.You have a bleeding disorder or have taken blood-thinning medication in the 3 weeks before the study, which makes getting a shot in your muscle unsafe according to the doctor.You have had a condition called intussusception in the past.You have a history of neurological disorders, including seizures and progressive neurological disorders.If anyone in your family has a genetic condition that affects their immune system, you will need to show that your immune system is working properly before receiving the vaccine.You have had diseases like diphtheria, tetanus, whooping cough, polio, hepatitis B, hepatitis A, measles, mumps, rubella, chickenpox, Haemophilus influenzae type b, Streptococcus pneumoniae, or rotavirus in the past.
- Group 1: Group 1a
- Group 2: Group 1b
- Group 3: Group 2a
- Group 4: Group 2b
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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