Status:
ACTIVE_NOT_RECRUITING
Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Papillomavirus Infections
Eligibility:
All Genders
9-26 years
Phase:
PHASE3
Brief Summary
This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investi...
Eligibility Criteria
Inclusion
- Boys and Girls 9 to 15 Years:
- \- Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
- Women 16 to 26 Years:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
- Cohort 0 Participants:
- \- Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
Exclusion
- All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Has received more than 1 dose of an HPV vaccine (Cohort 0)
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2029
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04708041
Start Date
March 15 2021
End Date
October 23 2029
Last Update
April 20 2025
Active Locations (30)
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1
Kaiser Permanente Daly City ( Site 0044)
Daly City, California, United States, 94015
2
Kaiser Permanente Oakland ( Site 0020)
Oakland, California, United States, 94611
3
Kaiser Permanente Roseville ( Site 0047)
Roseville, California, United States, 95661
4
Kaiser Permanente Sacramento ( Site 0043)
Sacramento, California, United States, 95815