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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLA1553 full dose | Experimental |
| |
| VLA1553 half dose | Experimental |
| |
| Control | Active Comparator | Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLA1553 full dose | Biological | Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of any adverse event (AE) | within 28 days post-vaccination | |
| Severity of any adverse event (AE) | within 28 days post-vaccination | |
| Frequency of unsolicited AE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valneva Clinical Development | Valneva Austria GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Dominicana de Perinatologia Fundacion Probebe | Santo Domingo | Gazcue | Dominican Republic | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41652122 | Derived | Weisova P, Scheiblauer S, Ecker J, Schneider M, Hochreiter R, Bitzer A, Kosulin K, Schoengrundner P, Fuchs U, Rodeles L, Mazara S, Donastorg Y, Rivera S, Wressnigg N, Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. Live-attenuated chikungunya vaccine in children: a randomized phase 2 trial. Nat Med. 2026 Feb;32(2):561-571. doi: 10.1038/s41591-025-04197-2. Epub 2026 Feb 6. |
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After trial completion, Valneva may provide access to individual de-identified participant data and related trial documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Trial Report (CTR)) upon request from qualified researchers, and subject to Valneva's review and approval.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2026 | Jun 2, 2026 | 7 |
| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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| VLA1553 half dose | Biological | Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate |
|
| Control | Biological | Nimenrix |
|
| 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 |
| 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 |
| Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP |
| Santo Domingo |
| 10306 |
| Dominican Republic |
| Inversiones en Investigacion Medica INVERIME | Tegucigalpa | Honduras |
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |