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A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents

NCT04650399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2024-05-03

No results posted yet for this study

Summary

This is a prospective, randomized, double-blinded, multicenter, pivotal 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 will be administered as single immunization on Day 1. Overall, approximately 750 male and female subjects aged 12 years to \<18 years will be enrolled into the study.

Conditions

  • Chikungunya

Interventions

BIOLOGICAL

Active

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Valneva Austria GmbH

    collaborator INDUSTRY

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Fernanda Boulos, MD, MSc · Butantan Institute

  • Valneva Austria GmbH · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-02-13
Completion
2024-02-15
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT04650399 on ClinicalTrials.gov