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

April 17, 2024 updated by: Valneva Austria GmbH

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (Nimenrix, a tetravalent meningococcal vaccine - Men ACWY).

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 (Nimenrix) (n=60).

As a safety precaution measure, the first 30 sentinel participants will be enrolled into the trial in an open-label fashion according to an age step down scheme.

After sentinel analysis, participants will be enrolled in a blinded, randomized manner into three Trial Arms. Within each treatment arm participants will be stratified into three age strata:

Stratum A: 7 to 11 years -children from their 7th birthday until the day before their 12th birthday.

Stratum B: 3 to 6 years - children from their 3rd birthday until the day before their 7th birthday.

Stratum C: 1 to 2 years - children from their 1st birthday until the day before their 3rd birthday.

Age strata for the VLA1553 treatment arms are targeted to be equal in size, i.e., approximately 40 per age stratum.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic, 10306
        • Recruiting
        • Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP
        • Contact:
          • Yeycy Donastorg, Dr.
    • Gazcue
      • Santo Domingo, Gazcue, Dominican Republic
        • Recruiting
        • Fundacion Dominicana de Perinatologia Fundacion Probebe
        • Contact:
          • Sonia Mazara, Dr.
  • Honduras
      • Tegucigalpa, Honduras
        • Recruiting
        • Inversiones en Investigacion Medica INVERIME
        • Contact:
          • Maribel Rivera, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of vaccination;
  2. Written informed consent by the participant's parent(s)/Legally Acceptable Representative(s) ((LAR(s)), according to local requirements, and written informed assent of the participant, if applicable;

Exclusion Criteria:

  1. Participant who is IgM+/IgG- does not qualify for participation in this trial.
  2. Participant is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical trial involving an investigational CHIKV vaccine;
  3. Participant has an acute or recent infection (and who is not symptom-free in the week prior to the Screening Visit (Visit 0)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VLA1553 full dose
Biological: VLA1553 full dose
Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate
Experimental: VLA1553 half dose
Biological: VLA1553 half dose
Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate
Active Comparator: Control
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
Biological: Control
Nimenrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of solicited injection site reactions
Time Frame: within 14 days post-vaccination
within 14 days post-vaccination
Severity of solicited injection site reactions
Time Frame: within 14 days post-vaccination
within 14 days post-vaccination
Frequency of systemic reactions
Time Frame: within 14 days post-vaccination
within 14 days post-vaccination
Severity of systemic reactions
Time Frame: within 14 days post-vaccination
within 14 days post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of any adverse event (AE)
Time Frame: within 28 days post-vaccination
within 28 days post-vaccination
Severity of any adverse event (AE)
Time Frame: within 28 days post-vaccination
within 28 days post-vaccination
Frequency of unsolicited AE
Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Severity of unsolicited AE
Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Frequency of any serious adverse event (SAE)
Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Severity of any serious adverse event (SAE)
Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers
Time Frame: on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valneva Austria GmbH

Investigators

  • Study Chair: Valneva Clinical Development, Valneva Austria GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLA1553-221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chikungunya Virus Infection

Clinical Trials on VLA1553 full dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe