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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Adenocarcinoma in Situ

Uterine Cervical Neoplasms

Vulvar Neoplasms

Condylomata Acuminata

Vaginal Neoplasms

Papillomavirus Infections

Treatments

Biological: 9vHPV vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03546842

2017-001205-33 (EudraCT Number)

V503-017 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

9 to 26 years old

Volunteers

Accepts Healthy Volunteers

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).
Female participants 16 to 26 years of age: history of HPV-related external genital lesions (e.g., condyloma acuminata, or vulvar intraepithelial neoplasia) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata, or vaginal intraepithelial neoplasia) or vaginal cancer, or HPV-related anal lesions (e.g., condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
Female participants: pregnant as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL beta human chorionic gonadotropin (β-hCG).
Female participants: expecting to donate eggs during the study.
Receiving or has received a prohibited immunosuppressive therapy in the year prior to the study
Received any immune globulin product or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during the study
Received inactivated or recombinant vaccines within 14 days prior to the Day 1 vaccination or has received live vaccines within 21 days prior to the Day 1 vaccination
Received a marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has received either active agent or placebo
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.