A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years

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.

Inclusion criteria

• 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 criteria

• 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)