At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 201 enrolled
Drug / intervention
9vHPV vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Open-label Safety and Immunogenicity Study of GARDASIL™9 Administered to 9- to 26-Year-Old Females and Males in Vietnam
In Brief
A Phase 3 clinical trial evaluating 9vHPV vaccine for Papillomavirus Infections and 5 related conditions. Completed, enrolled 201 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma in Situ, Condylomata Acuminata
CountriesVietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJun 2018
Primary CompletionJan 2019
TodayJul 2026
First PostedJun 6, 2018
Enrollment StartJun 29, 2018
Primary CompletionJan 29, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.1 years ago
Interventions
9vHPV vaccinebiological
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