Pertussis VaccinesNCT06888076
Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women
An observational study of Pertussis Vaccines and Pertussis (Whooping Cough), run by BioNet-Asia Co., Ltd. at 1 site in Thailand.
Trial summary
This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis Vaccines, Pertussis (Whooping Cough)
- Type of treatment
- Vaccines
- How many people
- 2,700 participants
- Where
- 1 siteThailand
- Study dates
- 12 Dec 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® which obtained from medical records in hospitals/clinics
Who may be able to join
- Data of pregnant women previously vaccinated with Pertagen® during second or third trimester of pregnancy and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® during pregnancy.
- Infant of pregnant women who received Pertagen® during second or third trimester of pregnancy
Who cannot join
- 1. pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: An Observational Study to Assess the Safety of Pertagen®, a Recombinant Acellular Pertussis Vaccine in Pregnant Women in Thailand
This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®.
Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical doctors as per requirements of each institutions. The assigned Ob-gyn specialist/physician at each study site will review the medical record of pregnant women (January 2020 to April 2024) based on study selection criteria. Safety information of pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® will be obtained from medical records in hospitals/clinics and will be reported in case report form (CRF) by assigned Ob-gyn specialist/physician at each study site. The assigned Ob-gyn specialist/physician at each study site who will review the medical records and report the data in case report form (CRF) is not part of the research team.
Read the detailed description
A CRF has been developed and will be used to collect safety information on pregnancy outcomes including the health status of infants at birth. The following definitions will be used for data collection
- The 2nd trimester of pregnancy is defined as gestational period between 13-26 weeks
- The 3rd trimester of pregnancy is defined as gestational period from 27 weeks to delivery.
- Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
- Preterm birth is defined as delivery of a baby at GA<37 weeks.
- Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
- Safety information of pregnancy and delivery outcome refers to health of women during pregnancy and childbirth (WHO 2024). The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia and heart disease (WHO 2024).
- A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
- A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.
To ensure the privacy and confidentiality of the collected data, strict adherence to all relevant data protection regulations will be followed.
- Conditions
- Pertussis Vaccines, Pertussis (Whooping Cough)
- Keywords
- Pertussis, whooping cough
- Medical subject headings
- Whooping Cough
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 |
|---|---|---|
| Pregnant women received Pertagen® and have given birth in Jan 2021-Apr 2024 and their infants | The pregnant women (previously vaccinated with Pertagen®) and have given birth in Thailand from Jan 2021 - Apr 2024 and infants born to pregnant women who received Pertagen®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 Number and percentage of pregnant women vaccinated with Pertagen who had experienced full term and preterm (or premature) delivery 1.2 Number and percentage of pregnant women vaccinated with Pertagen® who had experienced complications during delivery.
- Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
- Preterm birth is defined as delivery of a baby at GA<37 weeks.
- Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
Measured: Safety profile of Pertagen® in pregnant women at delivery
Secondary outcomes (1)
1 Number and percentage of healthy infants born to mothers who received Pertagen® during pregnancy. 2.2 Number and percentage of not healthy infants born to mothers who received Pertagen® during pregnancy
- A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
- A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.
Measured: Safety profile of Pertagen® in infants born to mother who received Pertagen® at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start12 Dec 2024
- Primary completion11 Apr 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis VaccinesStudies 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
- Retrospective
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNet-Asia Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soaud Mansouri, PhD., Study director, Bionet-Asia Co., Ltd (Branch1)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888076
- Sponsor's protocol ID
- PerMIS-01
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Safety of Pertagen®, a Recombinant Acellular Pertussis Vaccine in Pregnant Women in Thailand
- ClinicalTrials.gov ID
- NCT06888076
- Acronym / sponsor ID
- PerMIS-01
- Conditions
- Pertussis Vaccines, Pertussis (Whooping Cough)
- Keywords
- Pertussis, whooping cough
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- BioNet-Asia Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 21 Mar 2025 (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 is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®.
Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical doctors as per requirements of each institutions. The assigned Ob-gyn specialist/physician at each study site will review the medical record of pregnant women (January 2020 to April 2024) based on study selection criteria. Safety information of pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® will be obtained from medical records in hospitals/clinics and will be reported in case report form (CRF) by assigned Ob-gyn specialist/physician at each study site. The assigned Ob-gyn specialist/physician at each study site who will review the medical records and report the data in case report form (CRF) is not part of the research team.
Detailed description
A CRF has been developed and will be used to collect safety information on pregnancy outcomes including the health status of infants at birth. The following definitions will be used for data collection
- The 2nd trimester of pregnancy is defined as gestational period between 13-26 weeks
- The 3rd trimester of pregnancy is defined as gestational period from 27 weeks to delivery.
- Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
- Preterm birth is defined as delivery of a baby at GA<37 weeks.
- Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
- Safety information of pregnancy and delivery outcome refers to health of women during pregnancy and childbirth (WHO 2024). The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia and heart disease (WHO 2024).
- A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
- A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.
To ensure the privacy and confidentiality of the collected data, strict adherence to all relevant data protection regulations will be followed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women received Pertagen® and have given birth in Jan 2021-Apr 2024 and their infants | – | –The pregnant women (previously vaccinated with Pertagen®) and have given birth in Thailand from Jan 2021 - Apr 2024 and infants born to pregnant women who received Pertagen®. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® which obtained from medical records in hospitals/clinics
Key inclusion criteria (2 listed)
- Data of pregnant women previously vaccinated with Pertagen® during second or third trimester of pregnancy and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® during pregnancy.
- Infant of pregnant women who received Pertagen® during second or third trimester of pregnancy
Key exclusion criteria (1 listed)
- 1. pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.
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
1 Number and percentage of pregnant women vaccinated with Pertagen who had experienced full term and preterm (or premature) delivery 1.2 Number and percentage of pregnant women vaccinated with Pertagen® who had experienced complications during delivery.
Time frame: Safety profile of Pertagen® in pregnant women at delivery
* Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks. * Preterm birth is defined as delivery of a baby at GA<37 weeks. * Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
1 secondary outcome
1 Number and percentage of healthy infants born to mothers who received Pertagen® during pregnancy. 2.2 Number and percentage of not healthy infants born to mothers who received Pertagen® during pregnancy
Time frame: Safety profile of Pertagen® in infants born to mother who received Pertagen® at birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Soaud Mansouri, PhD. study director
Bionet-Asia Co., Ltd (Branch1)
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 Vaccines and Pertussis (Whooping Cough), 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 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
1 Number and percentage of pregnant women vaccinated with Pertagen who had experienced full term and preterm (or premature) delivery 1.2 Number and percentage of pregnant women vaccinated with Pertagen® who had experienced complications during delivery. (time frame: Safety profile of Pertagen® in pregnant women at delivery). 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 Oct 2025.