Trials / Completed
CompletedNCT03546842
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 9 Years – 26 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 9vHPV vaccine | 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 |
Timeline
- Start date
- 2018-06-29
- Primary completion
- 2019-01-29
- Completion
- 2019-01-29
- First posted
- 2018-06-06
- Last updated
- 2020-02-25
- Results posted
- 2020-02-05
Locations
1 site across 1 country: Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03546842. Inclusion in this directory is not an endorsement.