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Lot-to-Lot Consistency of VLA1553 in Healthy Adults
NCT04786444Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2021
- Primary completion
- Jul 2021
- Countries
- 1
- Sponsor
- Valneva
- Modality
- Small Molecules
- Drugs
- fezolinetant
- Conditions
- chikungunya virus infection
01
Overview
Phase 3, randomised, double-blind trial of fezolinetant in chikungunya virus infection (3 arms), sponsored by Valneva. Primary endpoint: Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies at Day 29. Started Feb 2021; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
VLA1553 Lot 1
Single dose of VLA1553 Lot 1
VLA1553 Lot 2
Single dose of VLA1553 Lot 2
VLA1553 Lot 3
Single dose of VLA1553 Lot 3
03
Who it enrols
Healthy adults aged 18-45 years without prior Chikungunya infection or significant medical history.
04
Endpoints
Primary
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies
Secondary
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers
Proportion of Subjects With Seroprotective Levels
Proportion of Subjects With Seroconversion
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Frequency of Solicited Injection Site Reactions
Frequency of Solicited Systemic Reactions
Frequency of Unsolicited Adverse Events
Frequency of Any Serious Adverse Event (SAE)
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