CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,128 enrolled
Drug / intervention
VLA1553 +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/NCT04546724
NCT04546724Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Pivotal Study To Evaluate Safety And Immunogenicity Of A Live-Attenuated Chikungunya Virus Vaccine Candidate In Adults Aged 18 Years And Above

Valneva Austria GmbH·interventional·Posted Sep 14, 2020·Updated Jun 28, 2023

In Brief

A Phase 3 clinical trial evaluating VLA1553 and Placebo for Chikungunya Virus Infection. Completed, enrolled 4,128 participants across 44 sites.

Detailed Summary

This was a prospective, randomized, double-blinded, multicenter, pivotal clinical study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control was administered as single immunization on Day 1. Overall, 4.128 male and female subjects aged 18 years and above were randomized into the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChikungunya Virus Infection
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 14, 2020
Enrollment StartSep 17, 2020
Primary CompletionMay 19, 2021
Study CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago

Interventions

VLA1553biological

Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose

Placebobiological

Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo