COVID-19 Paediatric VLA2001-321 Study

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. The study will consist of four parts: - Dose-finding part (participants aged ≥5 to <12 years) - Dose-finding part (participants aged ≥2 to <5 years) - Confirmatory part (participants aged ≥5 to <12 years) - Confirmatory part (participants aged ≥2 to <5 years) Dose-finding part (participants aged ≥5 to <12 years) Approximately 60 participants will receive 2 intramuscular doses of either half-dose VLA2001 (n=30) or full-dose VLA2001 (n=30) on Days 1 and 29 in a 1:1 ratio. Dose-finding part (participants aged ≥2 to <5 years) Approximately 60 participants will receive 2 intramuscular doses of either half-dose VLA2001 (n=30) or full-dose VLA2001 (n=30) on Days 1 and 29 in a 1:1 ratio. Dose-finding part for age group ≥2 to <5 years will be initiated after dose for age group ≥5 to <12 years is confirmed. Confirmatory Part (participants aged ≥5 to <12 years and ≥2 to <5 years) Overall, approximately 1600 participants aged ≥2 to <12 years will be enrolled. 800 participants aged ≥5 to <12 years and 800 participants aged ≥2 to <5 years will be randomized in 3:1 ratio. In each age group, 600 participants will receive VLA2001, and 200 participants comparator. Vaccination will start with either 1 intramuscular dose of VLA2001 (selected dose) or comparator vaccine. 28 days later all participants will receive a dose of VLA2001 (selected dose) and 28 days thereafter those who had received the comparator vaccine will receive their second dose with VLA2001 while those who have already received two doses of VLA2001 will receive the comparator vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05298644
Study type	Interventional
Source	Valneva Austria GmbH
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	October 1, 2022
Completion date	August 30, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.