Pertussis (Whooping Cough)BOOSTg001NCT07444502
Safety Monitoring of Boostagen® Vaccine in Thailand
An observational study of Pertussis (Whooping Cough) and Tetanus, run by BioNet-Asia Co., Ltd. at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis (Whooping Cough), Tetanus, Diphtheria
- Type of treatment
- Vaccines
- How many people
- 10,727 participants
- Where
- 1 siteThailand
- Study dates
- 30 Jun 2017to 27 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Unwilling to take part in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Post-licensure Safety Surveillance Study of the Combined Tetanus, Diphtheria (Reduced Dose) and Recombinant Acellular Pertussis Vaccine (TdaP), Boostagen®, in Thailand
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.
Read more
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®.
Read the 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).
- Conditions
- Pertussis (Whooping Cough), Tetanus, Diphtheria
- Keywords
- Pertussis vaccine, Combined Tetanus-Diphtheria-Acellular pertussis vaccine, Maternal immunization, Safety
- Medical subject headings
- Whooping Cough, Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Number and percentage of participants in each population group (children, adolescents and adults including pregnant women) experiencing unexpected SAEs after Boostagen® vaccination. Events will be identified through electronic health records and classified per CIOMS/WHO definitions of SAEs and safety signals, which include any serious medical occurrence that may indicate a new potential association requiring further evaluation.
Measured: 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
Number and percentage of participants with medically confirmed rare adverse events (events too uncommon to be detected in pre - licensure trials). Rare adverse event is defined as event occurring with a frequency of ≥ 1/10,000 and < 1/1,000).
Measured: 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
Number and percentage of participants presenting new patterns of adverse events already associated with pertussis containing vaccines (e.g., shifts in severity, timing, clustering). Safety signals include new aspects of known associations, per CIOMS/WHO definitions. Data will be analyzed using temporal clustering and disproportionality analysis to identify unexpected patterns following Boostagen® vaccination.
Measured: From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start30 Jun 2017
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis (Whooping Cough)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,727 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNet-Asia Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, PhD., Study director, BioNet-Asia Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444502
- Sponsor's protocol ID
- BOOSTg001
- Acronym
- BOOSTg001
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Post-licensure Safety Surveillance Study of the Combined Tetanus, Diphtheria (Reduced Dose) and Recombinant Acellular Pertussis Vaccine (TdaP), Boostagen®, in Thailand
- ClinicalTrials.gov ID
- NCT07444502
- Acronym / sponsor ID
- BOOSTg001 / BOOSTg001
- Conditions
- Pertussis (Whooping Cough), Tetanus, Diphtheria
- Keywords
- Pertussis vaccine, Combined Tetanus-Diphtheria-Acellular pertussis vaccine, Maternal immunization, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,727 participants (actual)
- Lead sponsor
- BioNet-Asia Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Unwilling to take part in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and percentage of AEFIs following vaccination with Boostagen®
Time frame: From the date of vaccination up to 30 days post-vaccination.
Measure the frequency, categorize the types, assess the severity, and determine the causal relationship to vaccination for all AEFIs.
Incidence and percentage of pregnant women vaccinated with Boostagen® who had experienced complications during pregnancy
Time frame: From administration of Boostagen® during pregnancy until delivery
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.
Incidence and percentage of healthy and not healthy infants born to mothers who received Boostagen® during pregnancy
Time frame: From maternal vaccination during pregnancy until birth of the infant
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.
3 secondary outcomes
Incidence and percentage of unexpected serious adverse events (SAEs) following Boostagen vaccination.
Time frame: 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
Time frame: 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
Time frame: From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director, PhD. study director
BioNet-Asia Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis (Whooping Cough) and Tetanus, run by BioNet-Asia Co., Ltd. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and percentage of AEFIs following vaccination with Boostagen® (time frame: From the date of vaccination up to 30 days post-vaccination.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.