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COMPLETED
NCT06106581
PHASE2

A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years

Sponsor: Valneva Austria GmbH

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control. At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (n=60).

Official title: A Randomized, Observer-blinded, Dose Response Phase 2 Trial to Assess the Safety and Immunogenicity of Two Different Dose Levels of a Live-attenuated Chikungunya Virus Vaccine (VLA1553) in Healthy Children Aged 1 to 11 Years

Key Details

Gender

All

Age Range

1 Year - 11 Years

Study Type

INTERVENTIONAL

Enrollment

304

Start Date

2023-12-18

Completion Date

2025-07-02

Last Updated

2026-08-13

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

VLA1553 full dose

Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate

BIOLOGICAL

VLA1553 half dose

Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate

BIOLOGICAL

Control

Nimenrix

Locations (3)

Fundacion Dominicana de Perinatologia Fundacion Probebe

Santo Domingo, Gazcue, Dominican Republic

Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP

Santo Domingo, Dominican Republic

Inversiones en Investigacion Medica INVERIME

Tegucigalpa, Honduras