Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year… (NCT03546842) | Clinical Trial Compass
CompletedPhase 3
Safety and Immunogenicity Study of V503 (GARDASILâ„¢9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
Vietnam201 participantsStarted 2018-06-29
Plain-language summary
This study will evaluate the safety and immunogenicity of V503 (GARDASILâ„¢9, 9vHPV vaccine) administered to 9- to 26-year-old females and males in Vietnam. The study hypothesis states that V503 induces acceptable anti-human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion at 4 weeks postdose 3.
Who can participate
Age range9 Years – 26 Years
SexALL
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Inclusion Criteria:
* In good physical health
* Participants 9 to 15 years of age: has not had coitarche and do not plan on becoming sexually active during the study
* Participants 16 to 26 year of age: has never had Papanicolaou (Pap) testing or has had only normal Pap test results. Has a lifetime history of ≤4 male and/or female sexual partners.
* Female participants 16 to 26 years of age: has not had sex with males or has had sex with males and used effective contraception, and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (rhythm method, withdrawal, and emergency contraception are not acceptable methods of contraception per-protocol).
Exclusion Criteria:
* Known allergy to any vaccine component, including aluminum, yeast, or BENZONASEâ„¢
* History of severe allergic reaction that required medical intervention
* Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
* Concurrently enrolled in clinical studies of investigational agents
* Immunocompromised or has been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
* Had a splenectomy
* User of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse o…
What they're measuring
1
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7