Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582277
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Immunogenicity and Safety of Two Dose Levels of OVX836 Influenza Vaccine As a Booster on Participants Previously Administered with OVX836
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2a Single Center Randomized Double-blind Study to Evaluate the Immunogenicity and Safety of One Single Administration of OVX836 Influenza Vaccine At Two Dose Levels 180μg or 480μg Given Intramuscularly IM Either As a Booster or a Primary Vaccination in Healthy Subjects aged 20-69 Years Previously Administered with OVX836 90μg to 480μg Influvac Tetra or Placebo in the OVX836-002 EudraCT Number 2019-002939-28 and OVX836-003 EudraCT Number 2021-002535-39 Studies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 2a is designed to evaluate the anamnestic response of a booster dose either 180 µg or 480 µg of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies Participants who had received a placebo or Influvac Tetra in previous studies would serve as controls and would receive one of these two doses of OVX836 vaccine either 180 µg or 480 µg as a primary vaccination
Detailed Description:
This is a phase 2a single center randomized double-blind study designed to evaluate the immunogenicity and safety of one single administration of OVX836 influenza vaccine at two dose levels 180μg or 480μg given intramuscularly either as a booster or a primary vaccination in approximately 214 healthy participants aged 20-69 years previously administered with OVX836 Influvac Tetra or placebo in the OVX836-002 EudraCT number 2019-002939-28 and OVX836-003 EudraCT number 2021-002535-39 studies This includes OVX836-002 participants who had received 90μg or 180μg OVX836 during the influenza season 2019-2020 and OVX836-003 participants who had received 180μg 300μg or 480μg OVX836 before the influenza season 2021-2022 Volunteers who received either Influvac Tetra in the OVX836-002 study or a placebo in the OVX836-003 study will serve as controls and will receive a primary single dose of OVX836 180μg or 480μg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None