Trial intelligence / Profile preview

VLA1553 in Healthy Children Aged 1 to 11 Years

NCT06106581Phase 2

Key facts

Status: Completed
Start: Dec 2023
Primary completion: Jul 2024
Countries: 2
Sponsor: Valneva
Modality: Small Molecules

Drugs: chikungunya vaccine (live)
Conditions: chikungunya virus infection

Overview

Phase 2, randomised, single-blind trial of chikungunya vaccine (live) in chikungunya virus infection (3 arms), sponsored by Valneva. Primary endpoints: Number of Participants With Solicited Injection Site Reactions at 14 days, Severity of Solicited Injection Site Reactions at 14 days and 2 more. Started Dec 2023; status: completed.

Design

3 arms

Study design: RandomizedSingle-blind

VLA1553 full dose
Single intramuscular vaccination on Day 1 with VLA1553 full dose
VLA1553 half dose
Single intramuscular vaccination on Day 1 with VLA1553 half dose
Control
Single intramuscular vaccination on Day 1 with Nimenrix

Who it enrols

Healthy children aged 1 to 11 years, seropositive or seronegative for previous CHIKV exposure. Excludes those with acute/recent infection, recent live/inactivated vaccines, immune defects, or history of vaccine-related contraindicating events.

Endpoints

Primary

Number of Participants With Solicited Injection Site Reactions14 days
Severity of Solicited Injection Site Reactions14 days
Number of Participants With Solicited Systemic Reactions14 days
Severity of Solicited Systemic Reactions14 days

Secondary

Number of Participants With Any Adverse Event (AE)28 days
Severity of Any Adverse Event (AE)28 days
Number of Participants With of Unsolicited AE12 months
Severity of Unsolicited AE12 months
Number of Participants With Any Serious Adverse Event (SAE)12 months
Number of Participants With Any Early Onset Adverse Event of Special Interest (AESI)2-21 days
Number of Participants With Any Late Onset Adverse Event of Special Interest (AESI)22 days to 12 months
Assessment of ViremiaDay 15

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