INTERNATIONAL VACCINE INSTITUTE

Vat0008 is a pivotal multi-country phase 3, multi-stage, modified double-blind and multi-arm study where efficacy, safety and immunogenicity of two sars-cov-2 adjuvanted recombinant protein vaccines (monovalent and bivalent) were tested as primary series and monovalent booster dose as an extension. Ivi led the effort in nepal to conduct the clinical trial including conducting the local dsmb meeting. The primary series study was initiated in july 2021. The first subject for the primary series was enrolled in september 2021. The crossover/booster phase started in january 2023. The last subject vaccination for the crossover/booster phase was completed in november 2023. Investigators meeting was conducted in february 2023 for the successful conduction of the primary series study. The 11th dsmb meeting was held on september 2023, and no safety concern was raised. Ivi team conducted a quality control visit in q3 2023. Final quality control visit to sites was done in q2 2024. Study site close-out was activity was completed in q3 2024. Study document archiving process was done in q3 2024. Final database lock was done in q3 2024. Final dsmb preparation was completed at the end of 2024, and meeting was conducted in january 2025. No safety concerns were raised.

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