V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
NCT ID: NCT05450705
Last Updated: 2022-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2022-07-22
2029-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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9 to 14 Years Old: Day 1 and Month 6
Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6
9vHPV vaccine
A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.
9 to 14 Years Old: Day 1 and Month 12
Chinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12
9vHPV vaccine
A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.
20 to 26 Years Old: Day 1, Month 2 and Month 6
Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6
9vHPV vaccine
A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.
Interventions
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9vHPV vaccine
A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.
Exclusion Criteria
* Has a history of severe allergic reaction that required medical intervention.
* Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
* Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
* Has a history of a positive test for HPV.
* Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
* Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
9 Years
26 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Jiangshan Center for Disease Control and Prevention ( Site 0001)
Quzhou, Zhejiang, China
Yuhuan Center for Disease Control and Prevention ( Site 0002)
Taizhou, Zhejiang, China
Countries
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Other Identifiers
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V503-071
Identifier Type: OTHER
Identifier Source: secondary_id
V503-071
Identifier Type: -
Identifier Source: org_study_id
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