Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:26 AM
Study NCT ID:
NCT07444502
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Monitoring of Boostagen® Vaccine in Thailand
Sponsor:
BioNet-Asia Co., Ltd.
Organization:
Study Overview
Official Title:
Enhanced Post-licensure Safety Surveillance Study of the Combined Tetanus, Diphtheria (Reduced Dose) and Recombinant Acellular Pertussis Vaccine (TdaP), Boostagen®, in Thailand
Status:
COMPLETED
Status Verified Date:
2026-02
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:
BOOSTg001
Brief Summary:
This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.
Doctors, nurses, and other healthcare professionals from hospitals and clinics in central, eastern, southern, and northern Thailand take part in the study. They report any health problems that occur after vaccination using standard reporting forms.
The information collected helps researchers understand how safe the vaccine is when used in a large and diverse population under real-world conditions.
Primary objective: To describe the post-licensure safety profile of Boostagen® in Thailand.
Secondary objective: To identify any unexpected safety signals following vaccination with Boostagen®.
Doctors, nurses, and other healthcare professionals from hospitals and clinics in central, eastern, southern, and northern Thailand take part in the study. They report any health problems that occur after vaccination using standard reporting forms.
The information collected helps researchers understand how safe the vaccine is when used in a large and diverse population under real-world conditions.
Primary objective: To describe the post-licensure safety profile of Boostagen® in Thailand.
Secondary objective: To identify any unexpected safety signals following vaccination with Boostagen®.
Detailed Description:
HCPs eligible to participate were those who prescribed or administered Boostagen®. as a booster immunization in line with national guidelines. Recruitment was carried out in hospitals and clinics located in central, eastern, southern and northern Thailand. HCPs who agreed to participate were interviewed periodically regarding adverse events following immunization (AEFIs) with Boostagen®.
Data collection was performed using a standardized questionnaire administered monthly, either in person or by telephone. The questionnaire captured the number and type of AEFIs observed, along with other safety-related information.
HCPs used a modified WHO AEFI report form to document adverse events. In addition, a pregnancy safety outcome report form was developed to collect data on pregnancy outcomes among vaccinated pregnant women and their newborn. This structured approach enabled systematic monitoring's safety profile in real-world conditions and ensured early identification of any unexpected safety signals.
Statistical Analysis. No formal prespecified study hypothesis was established. Descriptive statistical methods were applied to summarize demographic and baseline characteristics of Boostagen® recipients, including children, adolescents, adults, and pregnant women. The incidence rates and proportions of AEFIs were calculated. For pregnant women vaccinated with Boostagen®, pregnancy outcomes, pregnancy-related complications, and neonatal outcomes were summarized. Continuous variables were described using means and standard deviations, while categorical variables were presented as frequencies and percentages. Ninety-five percent confidence intervals (95% CIs) were calculated where appropriate. All statistical analyses were performed using SPSS software, version 18.0 (SPSS Inc., Chicago, IL, USA).
Data collection was performed using a standardized questionnaire administered monthly, either in person or by telephone. The questionnaire captured the number and type of AEFIs observed, along with other safety-related information.
HCPs used a modified WHO AEFI report form to document adverse events. In addition, a pregnancy safety outcome report form was developed to collect data on pregnancy outcomes among vaccinated pregnant women and their newborn. This structured approach enabled systematic monitoring's safety profile in real-world conditions and ensured early identification of any unexpected safety signals.
Statistical Analysis. No formal prespecified study hypothesis was established. Descriptive statistical methods were applied to summarize demographic and baseline characteristics of Boostagen® recipients, including children, adolescents, adults, and pregnant women. The incidence rates and proportions of AEFIs were calculated. For pregnant women vaccinated with Boostagen®, pregnancy outcomes, pregnancy-related complications, and neonatal outcomes were summarized. Continuous variables were described using means and standard deviations, while categorical variables were presented as frequencies and percentages. Ninety-five percent confidence intervals (95% CIs) were calculated where appropriate. All statistical analyses were performed using SPSS software, version 18.0 (SPSS Inc., Chicago, IL, USA).
Study Oversight
Has Oversight DMC:
False
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?: