NCT05298644

COVID-19 Paediatric VLA2001-321 Study

A Randomized, Double-Blinded, Active Controlled COVID-19 Study to Evaluate The Safety, Tolerability, And Immunogenicity Of Different Doses Of VLA2001 Vaccine, In Children (≥2 To <12 Years)

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	VLA2001	whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide
DRUG	Active Comparator	Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-07-31
• Completion: 2025-08-30
• First posted: 2022-03-28
• Last updated: 2022-11-08