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HPV Vaccine Regimens for Human Papillomavirus
Study Summary
This trial is testing the safety and effectiveness of a new HPV vaccine given in two or three doses over six years in boys, girls, and young women.
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.Side effects data
From 2019 Phase 3 trial • 201 Patients • NCT03546842Trial Design
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Who is running the clinical trial?
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- I have received an HPV vaccine or participated in an HPV vaccine trial.I received one HPV vaccine dose over a year ago and no others.I received one dose of the 9vHPV vaccine over a year ago and no other HPV vaccines since.I am a woman aged 16-26, never had or only had normal Pap tests, and have had up to 4 sexual partners.You have never had a Pap test before or have only had normal results in the past.I have not received any blood products or immunoglobulin in the last 3 months.I am pregnant or plan to donate eggs within the next 7 months.I have a bleeding or clotting disorder.I have had my spleen removed.I have been on immunosuppressive therapy in the past year.I have received at least 2 doses of the HPV vaccine.I am between 9 and 15 years old and have not had sex nor plan to during the vaccination period.I have had up to 4 sexual partners in my lifetime.I have not had sexual intercourse and do not plan to during the vaccination period.
- Group 1: Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)
- Group 2: Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart
- Group 3: Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart
- Group 4: Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart
- Group 5: Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart
- Group 6: Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period
- 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
Is this study only for patients that are 75 years or older?
"Children as young as 9 and young adults up to age 26 are able to participate in this trial, according to the listed eligibility criteria."
Could you please list the hospitals where this trial is being conducted?
"Currently, this study is being conducted out of Kaiser Permanente Sacramento ( Site 0043) in Sacramento, California, Tribe Clinical Research, LLC ( Site 0010) in Greenville, South carolina, and Kaiser Permanente Daly City ( Site 0044) in Daly City, Florida. There are also 14 other sites involved in this study."
What are the safety risks associated with the 9vHPV vaccine?
"The 9vHPV vaccine Phase 3 trial provides evidence of efficacy and multiple rounds of data confirming safety, so our team at Power gave it a score of 3."
Is recruitment currently underway for this research project?
"Unfortunately, this study is no longer recruiting patients, as was last updated on the clinicaltrials.gov website on May 18th, 2022. Although this specific trial is not enrolling, there are 76 other trials that are still looking for patients."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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