CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 614 enrolled
Drug / intervention
9vHPV Vaccine +1 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.

Search/NCT04313244
NCT04313244Phase 3Completed

A Phase 3, Open-Label, Randomized Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and an Intramuscular Recombinant 9-Valent Human Papillomavirus (9vHPV) Vaccine in Subjects Aged ≥9 to <15 Years in an Endemic Country for Dengue

Takeda·interventional·Posted Mar 18, 2020·Updated Feb 7, 2024

In Brief

A Phase 3 clinical trial evaluating 9vHPV Vaccine and Dengue Tetravalent Vaccine (TDV) for Dengue Fever. Completed, enrolled 614 participants across 4 sites.

Detailed Summary

The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesThailand
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 18, 2020
Enrollment StartMay 15, 2021
Primary CompletionFeb 21, 2022
Study CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.3 years ago

Interventions

9vHPV Vaccinebiological

9vHPV intramuscular injection

Dengue Tetravalent Vaccine (TDV)biological

TDV subcutaneous injection