drugset / Trial / NCT05298644

COVID-19 Paediatric VLA2001-321 Study

NCT05298644 ↗

Phase 2/3 Withdrawn Valneva Austria GmbH
RandomizedSequentialQuadruple-blindPrevention

Summary

This is a Randomized, Double-blinded, Active-controlled Study to evaluate the Safety, Tolerability and Immunogenicity of VLA2001 in participants of ≥2 to 12 years. In total 1720 participants will receive either VLA2001 or active Comparator.

Timeline

Start
2022-10-01
Primary completion
2023-07-31
Completion
2025-08-30

Outcome

Outcome not reported

Stopped: “Valneva has contacted regulators to align on potential adjustments to the previously agreed Pediatric Investigational Plan. Valneva has suspended VLA2001 pediatric development, and study VLA2001-321 will not commence.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine — —
Subject VLA2001 Vaccine — Intramuscular

Indications