Dengue Fever Clinical Trial
Official title:
A Phase II, Double-Blind, Randomized, Controlled Trial to Assess the Safety and Immunogenicity of a Tetravalent Dengue Vaccine With Two Different Serotype 2 Potencies in an Adult Population in Singapore
The purpose of this study is to assess the post-vaccination neutralizing antibody response against each dengue serotype by vaccine group.
The vaccine being tested in this study was Takeda's Tetravalent Dengue Vaccine Candidate
(TDV). TDV is being tested to protect people against dengue fever. This study looked at
safety and the titers of antibodies to dengue fever induced in people who were administered a
high-dose of TDV (HD-TDV) compared to TDV.
The study enrolled 351 patients. Before being assigned to a treatment group participants were
screened for previous exposure to the dengue virus using a Dengue immunoglobulin G (IgG)
enzyme-linked immunosorbent assay (ELISA). Participants were randomly assigned in 1:1 ratio
(by chance) to one of the two treatment groups—which remained undisclosed to the participant
and study doctor during the study (unless there is an urgent medical need):
- HD-TDV 0.5 mL subcutaneous injection
- TDV 0.5 mL subcutaneous injection
All participants received a single injection on Day 1. Participants were asked to record any
symptoms that may or may not be related to the vaccine or the injection site in a diary card
for 28 days after vaccination.
This multi-center trial was conducted in Singapore. The overall time of participation in this
study was 12 months. Participants made multiple visits to the clinic, including a final visit
1 year after receiving their dose of TDV.
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