At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 900 enrolled
Drug / intervention
TDV +3 morebiological
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 Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in Non-endemic Country(Ies) for Dengue
In Brief
A Phase 3 clinical trial evaluating TDV, HAV Vaccine, and 2 other interventions for Healthy Volunteers. Completed, enrolled 900 participants across 10 sites.
Detailed Summary
The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous \[SC\] injection) and of hepatitis A virus (HAV) vaccine (intramuscular \[IM\] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartMay 2018
Primary CompletionOct 2018
Study CompletionJul 2019
TodayJul 2026
First PostedMay 15, 2018
Enrollment StartMay 16, 2018
Primary CompletionOct 3, 2018
Study CompletionJul 9, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.1 years ago
Interventions
TDVbiological
TDV SC injection
HAV Vaccinebiological
HAV Vaccine IM injection.
TDV Placebobiological
Placebo-matching (normal saline (0.9% NaCl) SC injection.
HAV Vaccine Placebobiological
Placebo-matching (normal saline (0.9% NaCl) IM injection.