NCT04956224

Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

A Phase III, Open Label, Multicenter, Single Arm Study to Assess the Safety, Tolerability and Immunogenicity of VLA2001 in Volunteers Aged ≥ 56 Years.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 56 Years
• Healthy volunteers: Accepted

Summary

This is a A Phase III, Open label, Multicenter, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001 in volunteers aged ≥ 56 years. Approximately 300 participants are enrolled in a non-randomized manner.

Detailed description

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.

Conditions

• SARS-CoV-2 Virus 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 (Wuhan strain) 2 vaccinations 28 days apart Booster Vaccination on Visit B1

Timeline

• Start date: 2021-08-09
• Primary completion: 2021-11-10
• Completion: 2022-11-18
• First posted: 2021-07-09
• Last updated: 2023-09-01

Locations

8 sites across 1 country: New Zealand