A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
- Conditions
- Chikungunya Virus Infection
- Interventions
- Biological: ControlBiological: VLA1553 full doseBiological: VLA1553 half dose
- Registration Number
- NCT06106581
- Lead Sponsor
- Valneva Austria GmbH
- 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).
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 304
- 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;
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization VLA1553 full dose VLA1553 full dose - VLA1553 half dose VLA1553 half dose -
- Primary Outcome Measures
Name Time Method Frequency of solicited injection site reactions within 14 days post-vaccination Severity of solicited injection site reactions within 14 days post-vaccination Frequency of systemic reactions within 14 days post-vaccination Severity of systemic reactions within 14 days post-vaccination
- Secondary Outcome Measures
Name Time Method Frequency of any adverse event (AE) within 28 days post-vaccination Severity of any adverse event (AE) within 28 days post-vaccination Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination Frequency of unsolicited AE until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination Severity of unsolicited AE until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination Frequency of any serious adverse event (SAE) until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination Severity of any serious adverse event (SAE) until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Trial Locations
- Locations (3)
Inversiones en Investigacion Medica INVERIME
ðŸ‡ðŸ‡³Tegucigalpa, Honduras
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