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

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ClinicalTrials.gov Identifier: NCT06106581

Recruitment Status : Recruiting

First Posted : October 30, 2023

Last Update Posted : April 19, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Valneva Austria GmbH

Tracking Information

First Submitted Date ^ICMJE

October 24, 2023

First Posted Date ^ICMJE

October 30, 2023

Last Update Posted Date

April 19, 2024

Actual Study Start Date ^ICMJE

December 18, 2023

Estimated Primary Completion Date

July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Frequency of any adverse event (AE) [ Time Frame: within 28 days post-vaccination ]
Severity of any adverse event (AE) [ Time Frame: within 28 days post-vaccination ]
Frequency of unsolicited AE [ Time Frame: 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 ]
Frequency of any serious adverse event (SAE) [ Time Frame: 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 ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

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).

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Chikungunya Virus Infection

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: VLA1553 full dose
Intervention: Biological: VLA1553 full dose
Experimental: VLA1553 half dose
Intervention: Biological: VLA1553 half dose
Active Comparator: Control
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization

Intervention: Biological: Control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

July 2025

Estimated Primary Completion Date

July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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;
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:

Participant who is IgM+/IgG- does not qualify for participation in this trial.
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;
Participant has an acute or recent infection (and who is not symptom-free in the week prior to the Screening Visit (Visit 0)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

1 Year to 11 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact: Valneva Clinical Development

+4 1 206 20 ext 0

office@valneva.com

Listed Location Countries ^ICMJE

Dominican Republic, Honduras

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT06106581

Other Study ID Numbers ^ICMJE

VLA1553-221

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

Valneva Austria GmbH

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Valneva Austria GmbH

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Valneva Clinical Development

Valneva Austria GmbH

PRS Account

Valneva Austria GmbH

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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