Status:
COMPLETED
A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Chikungunya Virus Infection
Eligibility:
All Genders
1-11 years
Phase:
PHASE2
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 l...
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 (Nimen...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2025
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06106581
Start Date
December 18 2023
End Date
July 2 2025
Last Update
August 8 2025
Active Locations (3)
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1
Fundacion Dominicana de Perinatologia Fundacion Probebe
Santo Domingo, Gazcue, Dominican Republic
2
Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP
Santo Domingo, Dominican Republic, 10306
3
Inversiones en Investigacion Medica INVERIME
Tegucigalpa, Honduras