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CHIKV VLP Vaccine in Children 1 to <12 Years of Age
NCT07003984Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2025
- Primary completion
- Sep 2028
- Countries
- 3
- Sponsor
- Bavarian Nordic
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- CHIKV VLP vaccine
- Conditions
- chikungunya virus infection
01
Overview
Phase 3, randomised, double-blind trial of CHIKV VLP vaccine in chikungunya virus infection (4 cohorts), sponsored by Bavarian Nordic. Primary endpoints: Incidence of Adverse Events of Special Interest, Medically Attended Adverse Events, and Serious Adverse Events at Day 732, Anti-CHIKV SNA seroresponse rate in seronegative children at Day 22 and 1 more. Started Jun 2025; status: active, not recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Cohort 1 Active Group
CHIKV VLP vaccine
Cohort 1 Placebo Group
Placebo
Cohort 2 Active Group
CHIKV VLP vaccine
Cohort 2 Placebo Group
Placebo
03
Who it enrols
Healthy children aged 1 to <12 years weighing at least 6.5 kg, without current acute illness, prior CHIKV infection, or significant immunodeficiency.
04
Endpoints
Primary
Incidence of Adverse Events of Special Interest, Medically Attended Adverse Events, and Serious Adverse Events
Anti-CHIKV SNA seroresponse rate in seronegative children
Incidence of unsolicited adverse events
Secondary
Anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Incidence of solicited adverse events
Anti-CHIKV SNA seroresponse rate in seronegative children
Geometric Mean Titers of anti-CHIKV SNA
Geometric Mean Fold Increases
Frequency of participants with titer >=15 and 4-fold rise over baseline
Anti-CHIKV SNA seroresponse rates
Anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004
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