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A Trial to Evaluate the Safety and Immunogenicity of VLA1553 in Healthy Children

NCT07133178 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-12-31

No results posted yet for this study

Summary

VLA1553-322 is a multicenter, prospective, randomized, double-blind, phase 3 clinical trial evaluating VLA1553 in comparison to a comparator (Nimenrix®) for each stratum (age group). At least 3,000 male and female healthy children aged 1 to 11 years will be enrolled and randomized 3:1 to either VLA1553 (n=2,250) or comparator (Nimenrix®) (n=750).

Conditions

  • Chikungunya Virus Infection

Interventions

BIOLOGICAL

VLA1553

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

BIOLOGICAL

Control

Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Valneva Clinical Development · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2026-12-31
Completion
2027-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133178 on ClinicalTrials.gov