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Meningococcal Vaccine for Meningococcal Disease
Study Summary
This trial is testing whether a new vaccine is non-inferior to the current standard vaccine for infants and toddlers. It is also looking at the antibody response to the new vaccine and comparing it to the current standard.
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 must be either between 6-7 months old or 17-19 months old at the time of your first visit.You have a history of seizures or any other ongoing or worsening neurological conditions.You had a severe allergic reaction after receiving a tetanus vaccine in the past.You have a history of a medical condition called intussusception.You and your parent/guardian are able to attend all appointments and follow all trial procedures.You have had Guillain-Barré syndrome in the past.You have a bleeding disorder or have taken blood thinners in the past 3 weeks, which makes it unsafe for you to receive an injection in your muscle.You have a history of certain infections like diphtheria, tetanus, pertussis, polio, hepatitis B, hepatitis A, measles, mumps, rubella, chickenpox, and certain bacterial or viral infections.If you are 6 to 7 months old, you must have received 2 doses of various vaccines including DTaP, Hib, IPV, pneumococcal, hepatitis B, and rotavirus.If anyone in your family has a condition that weakens their immune system, you cannot participate until your own immune system is tested and shown to be strong.
- Group 1: Group 2
- Group 2: Group 4
- Group 3: Group 1
- Group 4: Group 3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Will this research be conducted with a subject pool of exclusively young adults?
"The lower age limit for this clinical trial is 6 months old and the maximum age is 19 months."
Are there other instances of a Hepatitis B Vaccine being tested in a clinical setting?
"The first clinical study for the Hepatitis b Vaccine took place in 2006 at Duke University Medical Center. As of now, 725 trials have been completed with 79 more currently active. A high concentration of these active trials are located in Miami, Idaho."
What are the primary objectives of the Hepatitis B Vaccine?
"By receiving the Hepatitis b Vaccine, patients can gain protection from developing gastroenteritis, mumps, and viral hepatitis b."
Has the Hepatitis B Vaccine received FDA backing?
"There is some evidence to support the efficacy of the Hepatitis b Vaccine, as this is a Phase 3 trial. Furthermore, it has received a safety score of 3."
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