Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT05546502
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2022-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
Sponsor:
PT Bio Farma
Organization:
Study Overview
Official Title:
A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
Status:
COMPLETED
Status Verified Date:
2025-06
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:
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
Detailed Description:
This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial.
The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.
Main Study for immunogenicity and safety evaluation.
Exploratory Study for cellular immunity evaluation,
The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.
Main Study for immunogenicity and safety evaluation.
Exploratory Study for cellular immunity evaluation,
Study Oversight
Has Oversight DMC:
True
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?: