Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864561
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2021-04-23
Brief Title:
COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222
Sponsor:
Valneva Austria GmbH
Organization:
Valneva Austria GmbH
Study Overview
Official Title:
A Randomized Observer-Blind Controlled Superiority Study To Compare The Immunogenicity Against COVID-19 Of VLA2001 Vaccine To AZD1222 Vaccine In Adults Including a Randomized Observer-blind Placebo Controlled Part in Adolescents 12 to 18 Years
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COV-COMPARE
Brief Summary:
This is a multicentre randomized observer-blind active-controlled superiority study in adults to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT of SARS-CoV-2-specific neutralising antibodies Furthermore VLA2001 will be compared to placebo in an adolescent population
Detailed Description:
Approximately 4000 Adult participants will be recruited in the study About 3000 participants aged 30 years and above will be randomized in a 21 ratio to receive 2 intramuscular recommended doses of either VLA2001 n2000 or AZD1222 n1000 In addition approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized open-label fashion to receive VLA2001 The 2 doses of vaccination for both vaccines will be administered 28 days apart on Days 1 and 29 All visits will be conducted at the clinical site on an outpatient basis
All participants - except those who already received a licensed COVID-19 vaccine outside of the study - will be offered a booster dose with VLA2001 between Jan and Mar 2022 and will have a follow-up visit 14 days Visit B2 and 6months after the booster dose
Approximately 660 Adolescent participants were planned to be recruited and randomized in a 11 ratio to receive 2 intramuscular doses of either VLA2001 n330 or placebo n300 Participants in the placebo group will receive a 2-dose primary immunization with VLA2001 on Day 85 and the second vaccination 28 days later For safety reasons the first 16 adolescents will be enrolled in an open label non-randomized manner sentinel dosing
Recruitment of adolescent participants has been stopped after recruitment of 6 randomized participants 3 randomized to VLA2001 and 3 participants randomized to placebo due to the low recruitment rate The study design ensures a safety follow-up of at least 6 months after the last VLA2001 vaccinationbooster for all enrolled study participants
Participants will be provided with an electronic Diary e-Diary and will be trained to record specifically solicited systemic and local symptoms daily as well as any additional AEs during follow-up period after each of both vaccinations up to the next visit to the site until Day 43 visit has been completed
All participants - except those who already received a licensed COVID-19 vaccine outside of the study - will be offered a booster dose with VLA2001 between Jan and Mar 2022 and will have a follow-up visit 14 days Visit B2 and 6months after the booster dose
Approximately 660 Adolescent participants were planned to be recruited and randomized in a 11 ratio to receive 2 intramuscular doses of either VLA2001 n330 or placebo n300 Participants in the placebo group will receive a 2-dose primary immunization with VLA2001 on Day 85 and the second vaccination 28 days later For safety reasons the first 16 adolescents will be enrolled in an open label non-randomized manner sentinel dosing
Recruitment of adolescent participants has been stopped after recruitment of 6 randomized participants 3 randomized to VLA2001 and 3 participants randomized to placebo due to the low recruitment rate The study design ensures a safety follow-up of at least 6 months after the last VLA2001 vaccinationbooster for all enrolled study participants
Participants will be provided with an electronic Diary e-Diary and will be trained to record specifically solicited systemic and local symptoms daily as well as any additional AEs during follow-up period after each of both vaccinations up to the next visit to the site until Day 43 visit has been completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None