Safety Monitoring of Boostagen® Vaccine in Thailand

NCT07444502 | Completed

• 1 other identifier: BOOSTg001
• Study Type: observational
• Target: 10,727
• Locations: 1 country
• Sites: 1

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®.

Conditions

Pertussis (Whooping Cough); Tetanus; Diphtheria

Keywords

Pertussis vaccine; Combined Tetanus-Diphtheria-Acellular pertussis vaccine; Maternal immunization; Safety

Outcome Measures

Primary Outcomes (3)

• Incidence and percentage of AEFIs following vaccination with Boostagen®

  Measure the frequency, categorize the types, assess the severity, and determine the causal relationship to vaccination for all AEFIs.

  From the date of vaccination up to 30 days post-vaccination.

• Incidence and percentage of pregnant women vaccinated with Boostagen® who had experienced complications during pregnancy

  Incidence rate is defined as the number of maternal complications in 1000 vaccinees. Pregnancy complications include but are not limited to the following: pregnancy loss or stillbirth, preterm delivery (\< 37 weeks of gestation), premature rupture of membranes, pregnancy-induced hypertension, pre-eclampsia/eclampsia, intrauterine growth restriction (IUGR), obstetric hemorrhage, and gestational diabetes.

  From administration of Boostagen® during pregnancy until delivery

• Incidence and percentage of healthy and not healthy infants born to mothers who received Boostagen® during pregnancy

  Incidence rate is defined as the number of healthy and not healthy infants in 1000 infants born to mothers who received Boostagen® during pregnancy. This outcome assesses the health status of infants born to mothers who received Boostagen® during pregnancy. Infants will be classified at birth as healthy or not healthy based on clinical assessment and review of delivery and neonatal records. A healthy infant is defined as a live-born infant without any congenital anomalies, neonatal complications, or conditions requiring significant medical intervention at birth. A not healthy infant is defined as a live-born infant with at least one reported adverse neonatal outcome, including but not limited to congenital anomalies, preterm birth, low birth weight, neonatal intensive care unit (NICU) admission, or other clinically significant medical conditions identified at or shortly after birth.

  From maternal vaccination during pregnancy until birth of the infant

Secondary Outcomes (3)

• Incidence and percentage of unexpected serious adverse events (SAEs) following Boostagen vaccination.

  From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.

• Incidence and percentage of rare adverse events following Boostagen® vaccination

  From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.

• Incidence and percentage of new patterns of known adverse events

  From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.

Study Arms (1)

Boostagen® recipients

Vaccinees consist of children, adolescents and adults including pregnant women in private and government hospitals and clinics located in the central, eastern, northern, and southern regions of Thailand.

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a cohort of HCPs working in private and government hospitals and clinics in central, eastern, northern and southern Thailand where Boostagen® vaccine is marketed. An HCP is defined as medically qualified person, such as physician, nurse or pharmacist.

You may qualify if:

• Has prescribed and/or administered Boostagen® to children, adolescents and adults in accordance with current national immunization guidelines.
• Employed full-or part-time (\> 8 hours/week) in a government or private hospital or medical clinic.
• Available for follow-up by telephone call, email or site visit if there are missing information in the study questionnaire, to confirm the occurrence or clarify the nature of an adverse event following immunization with Boostagen®.
• Willing and able to comply with the study procedures.

You may not qualify if:

• Unwilling to take part in the study.

Sponsors & Collaborators

• BioNet-Asia Co., Ltd.: lead

Study Sites (1)

BioNet-Asia Co., Ltd.

Bangkok, 10260, Thailand

Location

MeSH Terms

Conditions

Whooping Cough; Tetanus; Diphtheria

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections

Study Officials

• Study Director, PhD.

  BioNet-Asia Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: June 30, 2017
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

TH (1)