NCT03525119

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

The vaccine tested in this study is TDV. TDV co-administered with HAV vaccine will be tested to assess immunogenicity and safety in healthy participants in non-endemic area(s) for dengue and HAV. The study will enroll approximately 900 patients. Participants will be randomly assigned to one of the three groups-which will remain undisclosed to the observer. Participants will be randomized in 1:1:1 ratio to receive: * Group 1: HAV vaccine (IM) and TDV placebo-matching injection (SC), co-administered at Day 1 (Month 0 \[M0\]); TDV placebo-matching injection (SC) administered at Day 90 (Month 3 \[M3\]) * Group 2: TDV (SC) and HAV placebo-matching injection (IM), co-administered at Day 1 (Month 0 \[M0\]); TDV (SC) administered at Day 90(Month 3 \[M3\]) * Group 3: TDV (SC) and HAV vaccine (IM), co-administered at Day 1 (Month 0 \[M0\]); TDV (SC) administered at Day 90 (Month 3 \[M3\]) This multi-center trial will be conducted in United Kingdom. The overall time to participate in this study is 270 days. Participants will have multiple visits to the clinic with a 6-months follow up after the last study administration, including a final visit at Day 270.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	TDV	TDV SC injection
BIOLOGICAL	HAV Vaccine	HAV Vaccine IM injection.
BIOLOGICAL	TDV Placebo	Placebo-matching (normal saline (0.9% NaCl) SC injection.
BIOLOGICAL	HAV Vaccine Placebo	Placebo-matching (normal saline (0.9% NaCl) IM injection.

Timeline

• Start date: 2018-05-16
• Primary completion: 2018-10-03
• Completion: 2019-07-09
• First posted: 2018-05-15
• Last updated: 2022-08-19
• Results posted: 2020-07-13

Locations

10 sites across 1 country: United Kingdom