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Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)

A Phase III Open-label Safety and Immunogenicity Study of GARDASIL™9 Administered to 9- to 26-Year-Old Females and Males in Vietnam

NCT03546842•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and immunogenicity of V503 (GARDASIL™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.

Eligibility

Age

9 - 26 years

Sex

ALL

Healthy Volunteers

Yes

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 BENZONASE™
•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 or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
•History of a positive test for HPV
•Male participants 16 to 26 years of age: history of HPV-related external genital lesions (e.g., condyloma acuminata) or HPV-related anal lesions (e.g., condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
•Female participants 16 to 26 years of age: history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia or worse).
+8 more criteria

Locations (1)

National Institute of Hygiene and Epidemiology ( Site 0001)

Hanoi, Vietnam

Key Dates

Start Date

June 29, 2018

Primary Completion Date

January 29, 2019

Completion Date

January 29, 2019

Last Updated

February 25, 2020

Enrollment

201

ACTUAL participants

Conditions

Papillomavirus InfectionsUterine Cervical NeoplasmsVulvar NeoplasmsVaginal NeoplasmsAdenocarcinoma in SituCondylomata Acuminata

Interventions

9vHPV vaccine

BIOLOGICAL

Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women

NCT07011836

Uterine Cervical Neoplasms

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RECRUITINGNA

Danish Vulva Cancer Recurrence Study

NCT06495554

Vulva CancerVulva Neoplasm+7 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)

Inclusion Criteria

Exclusion Criteria

Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women

Danish Vulva Cancer Recurrence Study

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