Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181292
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-11-28
Brief Title:
Safety and Immunogenicity of a Booster Vaccination with an Adapted Vaccine
Sponsor:
Hipra Scientific SLU
Organization:
Hipra Scientific SLU
Study Overview
Official Title:
Phase IIbIII Double-Blind Randomised Active-Controlled Multi-Center Non-Inferiority Clinical Trial to Assess the Safety and Immunogenicity of a Booster Vaccination with an Adapted Recombinant Protein RBD Fusion Homodimer Candidate Against SARS-CoV-2 in Adults Vaccinated Against COVID-19
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a phase IIbIII double-blind randomised active-controlled multi-centre non-inferiority clinical trial that aims to determine safety tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain RBD fusion homodimer of XBB116 adapted candidate against SARS-CoV-2 developed by HIPRA PHH-1V81
Detailed Description:
This is a phase IIbIII double-blind randomised active-controlled multi-centre non-inferiority clinical trial that aims to determine safety tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain RBD fusion homodimer of XBB116 adapted candidate against SARS-CoV-2 developed by HIPRA PHH-1V81
Approximately 612 participants who have received a primary scheme with an EU-approved mRNA vaccine two doses and at least one booster dose of an EU-approved mRNA vaccine against COVID-19 will be randomly assigned to the following two treatment arms in a PHH-1V81 Comirnaty Omicron XBB15 21 ratio
PHH-1V81 vaccine arm Approximately 408 adults will receive a booster dose of PHH-1V81 HIPRA adapted vaccine
Comirnaty vaccine arm Approximately 204 adults will receive a booster dose of Comirnaty Omicron XBB15
Participants will be stratified before randomisation by age group approximately 10 of adults 60 years old and by number of doses previously received
All participants will receive a booster dose of PHH-1V81 or Comirnaty Omicron XBB15 at Day 0 and will be followed for 6 months All subjects will be closely observed for 15 minutes after vaccination on site
Approximately 612 participants who have received a primary scheme with an EU-approved mRNA vaccine two doses and at least one booster dose of an EU-approved mRNA vaccine against COVID-19 will be randomly assigned to the following two treatment arms in a PHH-1V81 Comirnaty Omicron XBB15 21 ratio
PHH-1V81 vaccine arm Approximately 408 adults will receive a booster dose of PHH-1V81 HIPRA adapted vaccine
Comirnaty vaccine arm Approximately 204 adults will receive a booster dose of Comirnaty Omicron XBB15
Participants will be stratified before randomisation by age group approximately 10 of adults 60 years old and by number of doses previously received
All participants will receive a booster dose of PHH-1V81 or Comirnaty Omicron XBB15 at Day 0 and will be followed for 6 months All subjects will be closely observed for 15 minutes after vaccination on site
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