VLA1553-322 is a multicenter, prospective, randomized, double-blind, phase 3 clinical trial evaluating VLA1553 in comparison to a comparator (Nimenrix®) for each stratum (age group). At least 3,000 male and female healthy children aged 1 to 11 years will be enrolled and randomized 3:1 to either VLA1553 (n=2,250) or comparator (Nimenrix®) (n=750).
This is a multicenter, prospective, randomized, double-blind, Phase 3 clinical trial evaluating VLA1553 in comparison to a comparator (Nimenrix®) in healthy children aged 1 to 11 years after a single vaccination in endemic countries. The overall trial duration (First Participant In - Last Participant Out) is estimated to be approximately 22 months. Individual participation is approximately 13 months (immunogenicity subset) from ICF signature to trial completion, unless prematurely discontinued. At least 3,000 male and female healthy children aged 1 to 11 years will be enrolled and randomized 3:1 to either VLA1553 (n=2,250) or comparator (Nimenrix®) (n=750). These children will be screened for evidence of previous CHIKV exposure. The trial will be conducted in Latin America and / or Southeast Asia to ensure a diverse participant population and broad applicability of results. An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety, review interim data, and provide recommendations on the trial's continuation. Additionally, a Valneva internal Safety Review Committee (SRC) will review safety data according to their pertinent SRC Charter. The trial is divided into three sequential parts with predefined timepoints: Part A (Day 29, Visit 4), Part B (Month 6, Visit 6) and Part C (Month 12, Visit 7). Analyses for each part will be conducted independently after the last participant completes the respective visit, with Part A analyzed after Day 29, Part B after Month 6, and Part C after Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
The proportion of participants with a seroresponse as defined by μPRNT50 for baseline negative participants
Time frame: 28 days post-vaccination
Immune response as measured by CHIKV-specific neutralizing antibody titers as determined by μPRNT assay
Time frame: on Day 1, Day 15, Day 29, Day 85, Day 180, and Month 12 (Day 365)
Proportion of participants with seroresponse as determined by μPRNT assay
Time frame: on Day 15, Day 29, Day 85, Day 180 and Month 12 (Day 365)
Proportion of participants with seroconversion as compared to baseline as determined by μPRNT assay
Time frame: on Day 15, Day 29, Day 85, Day 180 and Month 12 (Day 365)
Fold increase of CHIKV-specific neutralizing antibody titers determined by μPRNT assay as compared to baseline
Time frame: on Day 15, Day 29, Day 85, Day 180 and Month 12 (Day 365)
Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold, or 64-fold increase in CHIKV-specific neutralizing antibody titers compared to baseline as measured by μPRNT assay
Time frame: on Day 15, Day 29, Day 85, Day 180 and Month 12 (Day 365)
Antibody titers, seroresponse, seroconversion and fold increases for CHIKV-specific neutralizing antibodies, determined by μPRNT assay stratified by CHIKV baseline serostatus (based on μPRNT) and age stratum
Time frame: at Day 15, Day 29, Day 85, Day 180 and Month 12 (Day 365)
Frequency and severity of any Adverse Event (AE), stratified by CHIKV baseline serostatus and age stratum
Time frame: until Day 29
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Frequency and severity of unsolicited Adverse Events (AE), stratified by CHIKV baseline serostatus and age stratum
Time frame: until Day 180 and Month 12
Frequency and severity of solicited injection site and systemic Adverse Event (AE), stratified by CHIKV baseline serostatus and age stratum
Time frame: within 14 days post-vaccination
Frequency and relatedness of any Serious Adverse Event (SAE), stratified by CHIKV baseline serostatus and age stratum
Time frame: during entire trial period
Frequency and severity of any adverse event of special interest (AESI), stratified by CHIKV baseline serostatus and age stratum
Time frame: starting within 2 to 21 days post-vaccination
Frequency and severity of any late onset adverse event of special interest (AESI), stratified by CHIKV baseline serostatus and age stratum
Time frame: during the entire trial starting 22 days post-vaccination
Frequency and severity of adverse event of special interest (AESI) (regulatory agency definition), stratified by CHIKV baseline serostatus and age stratum
Time frame: with an onset within 30 days post-vaccination