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Panblok H7 Vaccine for Flu Prevention
Study Summary
This trial is testing a new vaccine for adults, to compare different doses & find the best one to use for further development.
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- You are at least 18 years old when you join the study.You have read and signed a form that explains the study and you agree to participate.You are medically evaluated and deemed healthy based on your medical history and physical examination.You have received an experimental vaccine for H7N9 in the past.You are able to have children and agree to use effective birth control or not have sex for at least 4 weeks before and 12 weeks after the study.If you are a woman who could become pregnant, you need to have a negative pregnancy test within 24 hours before starting the study.You have cancer, except for certain types that are stable or if you have been cancer-free for at least 5 years.You have a low platelet count or a bleeding disorder that makes receiving injections unsafe according to the doctor's opinion.You or someone in your family has a history of Guillain-Barré syndrome.Women who cannot become pregnant are eligible for the study. This includes women who have gone through menopause for at least a year or have had a surgery to prevent pregnancy.You have a weakened immune system due to a medical condition or medication.You have received immune globulins, blood, or blood-derived products in the last 3 months.You have a long-term illness that might make it difficult to participate in the study.You have tested positive for Hepatitis B or Hepatitis C.You have a history of using alcohol, prescription drugs, or other substances that could affect the study.
- Group 1: Group 2
- Group 2: Group 3
- Group 3: Group 1
- 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
Does Group 1 meet all criteria to be given the green light by the FDA?
"Our team at Power determined Group 1's safety to be a 2, as only preliminary data exists that suggests its level of security. This is due to this being a Phase 2 trial, in which there has been no evidence established for efficacy."
To what extent has the capacity of this experiment been maximized?
"This clinical trial requires 700 participants that fit the criteria. WR-ClinSearch, LLC (Site Number:8400003) in Chattanooga, Tennessee and Suncoast Research Associates, LLC (Site Number:8400008) in Miami, North carolina are among some of the sites offering enrolment for this study."
What are the desired outcomes of this investigation?
"This medical trial will determine its success by the Percentage of participants with seroconversion and measure secondary outcomes, such as Number of patients that experience Adverse Events of Special Interest (AESIs), Unsolicited AEs, or Medically Adverse Events (MAAEs) at Day 387."
Are there any remaining vacancies to participate in this research?
"According to the clinicaltrials.gov database, this research endeavor is currently looking for volunteers; it was initially posted on November 3rd 2022 and subsequently updated on the 9th of that same month."
Is the scope of this trial limited to a few select locations within the U.S.?
"Potential participants in this clinical trial can be enrolled at WR-ClinSearch, LLC (Site Number:8400003) located in Chattanooga, TN; Suncoast Research Associates, LLC (Site Number:8400008) situated in Miami, NC; and Wrightsville Family Practice Pa (Site Number:8400025) based out of Wilmington, IN. Additionally there are 16 other recruitment sites available."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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