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

NCT03546842 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V503-0172017-001205-33
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Adenocarcinoma in Situ; Condylomata Acuminata

Outcome Measures

Primary Outcomes (1)

• Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

  Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.

  4 weeks postdose 3 (Month 7)

Secondary Outcomes (5)

• Percentage of Participants With a Solicited Injection-site Adverse Event

  Up to 5 days after any vaccination

• Percentage of Participants With a Solicited Systemic Adverse Event

  Up to 5 days after any vaccination

• Percentage of Participants With a Vaccine-related Serious Adverse Event

  Up to 4 weeks postdose 3 (Month 7)

• Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1

  Day 1 (predose)

• Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

  4 weeks postdose 3 (Month 7)

Study Arms (1)

9vHPV vaccine

EXPERIMENTAL

Participants will receive a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

Biological: 9vHPV vaccine

Interventions

9vHPV vaccine BIOLOGICAL

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine in a 0.5-mL intramuscular injection

Also known as: V503, GARDASIL™9

9vHPV vaccine

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

National Institute of Hygiene and Epidemiology ( Site 0001)

Hanoi, 100000, Vietnam

Location

Related Publications (1)

• Thiem VD, Quang ND, Tuan NH, Cheon K, Gallagher N, Luxembourg A, Group T, Badshah C. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in Vietnamese males and females (9 to 26 years of age): an open-label, phase 3 trial. Hum Vaccin Immunother. 2021 Jul 3;17(7):1980-1985. doi: 10.1080/21645515.2020.1865739. Epub 2021 Apr 12.

  PMID: 33844623 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Adenocarcinoma in Situ; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Vulvar Diseases; Vaginal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Morphological and Microscopic Findings; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trials Disclosure
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: June 29, 2018
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: February 25, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)