Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05873374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-05-23
Brief Title:
Evaluation of Safety Tolerability Reactogenicity Immunogenicity of Baiya SARS-CoV-2 Vax 2 as a Booster for COVID-19
Sponsor:
Baiya Phytopharm Co Ltd
Organization:
Baiya Phytopharm Co Ltd
Study Overview
Official Title:
A Phase 2 Study to Evaluate the Safety Tolerability Reactogenicity and Immunogenicity of Baiya SARS-CoV-2 Vax 2 Vaccine as a Booster Following Vaccination for COVID-19 in Adults Between 18 and 64 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease
This is a Phase 2 randomised and double-blinded study to assess the safety tolerability reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines
This is a Phase 2 randomised and double-blinded study to assess the safety tolerability reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines
Detailed Description:
This is a Phase 2 randomised and double-blinded study The participants will be randomised to receive either the investigational product or the placebo at a ratio of 21 05 mL of the assigned vaccine will be administered as an IM injection Each participant will be followed up for 6 months after vaccination
The primary objective aims to assess the safety tolerability and reactogenicity of Baiya SARS-CoV-2 Vax 2 vaccine in adults 18-64 years old as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines
The secondary objective aims to evaluate safety tolerability reactogenicity and immunogenicity up to 28 days after the booster vaccination
An interim analysis of all safety and available immunogenicity data up to Visit 6 Day 29 3 will be conducted for the DSMB review
The primary objective aims to assess the safety tolerability and reactogenicity of Baiya SARS-CoV-2 Vax 2 vaccine in adults 18-64 years old as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines
The secondary objective aims to evaluate safety tolerability reactogenicity and immunogenicity up to 28 days after the booster vaccination
An interim analysis of all safety and available immunogenicity data up to Visit 6 Day 29 3 will be conducted for the DSMB review
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?:
False
Is an FDA AA801 Violation?:
None