A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
NCT ID: NCT06106581
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
304 participants
INTERVENTIONAL
2023-12-18
2025-07-02
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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VLA1553 full dose
VLA1553 full dose
Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate
VLA1553 half dose
VLA1553 half dose
Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate
Control
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
Control
Nimenrix
Interventions
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VLA1553 full dose
Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate
VLA1553 half dose
Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate
Control
Nimenrix
Eligibility Criteria
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Inclusion Criteria
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
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)
1 Year
11 Years
ALL
Yes
Sponsors
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Valneva Austria GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Valneva Clinical Development
Role: STUDY_CHAIR
Valneva Austria GmbH
Locations
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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
Countries
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Other Identifiers
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VLA1553-221
Identifier Type: -
Identifier Source: org_study_id
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