Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

This Phase 3 study is designed as a Multicentre, Open Label, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001. Participants aged 56 years or older and who are either generally healthy or are with a stable medical condition are enrolled. Approximately 300 participants will be enrolled in a non-randomized manner to receive VLA2001 at the recommended dose level, 28 days apart on Days 1 and 29. Immunogenicity and safety will be assessed up to month 12 after the first vaccination. All participants, except those who already received a licensed COVID-19 vaccine outside of the study, will be offered a booster dose with VLA2001. All eligible and willing participants will receive a booster vaccination with VLA2001 and will have a follow-up visit 14 days after the booster dose. The participants will have 1 more follow-up visit 6 months after the booster vaccination which replaces Day 365 for those participants who received a booster dose. This study will support the VLA2001 safety and immunogenicity database for vaccines aged ≥56 years.