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Pertussis VaccinePhase 3PertaSafeNCT06798831

Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults

A Phase 3 study testing Pertussis containing vaccine in people with Pertussis Vaccine, run by BioNet-Asia Co., Ltd. at 3 sites in Thailand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate the incidence and characteristics of adverse drug reactions (ADRs), including uncommon events, to provide robust safety data. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Pertussis Vaccine
What is being tested?
Pertussis containing vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,399 participants
Where
3 sitesThailand
Study dates
8 Feb 2025to 31 Oct 2025
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • An adult participant will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
  • Aged 18 to 75 years (less than 76 years full of age) on the day of inclusion;
  • Can provide written informed consent;
  • Healthy, as established by pertinent medical history and physical examination;
  • Capable of complying with the study protocol and procedures;
  • For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilization, hysterectomy or who are post-menopausal.), must have a negative urine pregnancy test at enrollment.

Who cannot join

  • A participant with ANY of the following criteria at study entry will not be eligible for participation:
  • History of significant medical illness such as but not limited to immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination. For those cases that are clinically stable, the investigator may include them as deemed per medical judgement.
  • Breastfeeding women or female participants who intend to become pregnant during the study period;
  • History of a severe allergic reaction to any vaccine (including its components);
  • History of serious adverse event or neurological adverse event to any vaccination;
  • Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines);
Show all 16Show fewer
  • Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period;
  • Having experienced physician-diagnosed pertussis within 5 year prior to enrollment;
  • Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior to enrollment;
  • Having any progressive or severe neurologic disorder, seizure disorder or recent history of Guillain-Barré syndrome;
  • Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years);
  • A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;
  • Suspected or known alcoholism and/or illicit drug abuse within the past 5 years;
  • Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
  • History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to study entry;
  • Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

  • Chula Clinical Research Center (Chula CRC)

    Bangkok, Bangkok, 10330

  • Queen Saovabha Memorial Institute, Thai Red Cross Society

    Bangkok, Bangkok, 10330

  • Thai Red Cross AIDS and Infectious Diseases Research Centre

    Bangkok, Bangkok, 10330

Other trials in Thailand

About this study

Official title: A Randomized, Observer-blind, Active-controlled Study to Describe the Safety of Recombinant Acellular Pertussis (aP) Vaccine When Administered to Healthy Adults Aged of 18-75 Years Old

This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate the incidence and characteristics of adverse drug reactions (ADRs), including uncommon events, to provide robust safety data. The study focuses on identifying and describing all ADRs following vaccination with BioNet recombinant acellular pertussis (aP) vaccine, ensuring the vaccine's safety is well-characterized in a large population. This study will also describe the lot-to-lot consistency between three lots of BioNet recombinant acellular pertussis (aP) vaccine across safety outcomes.

Read the detailed description

This is a pivotal, multi-site, observer-blind, randomized, active-controlled vaccine trial in which 2400 healthy adults aged 18 to 75 years will be recruited at approximately 7:1 ratio from three sites in Bangkok, Thailand. As the aim of this trial is to extend the safety database for recombinant acellular pertussis (aP) vaccine in a larger population of adults, the active-controlled arm is added mainly to reduce selection and measurement bias through randomization and blinding methods.

Being tested
Pertussis containing vaccine
Keywords
Recombinant Pertussis Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pertussis containing vaccineBiological

    Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),

Study groups in NCT06798831
Study groupRoleWhat they receive
BoostrixActive comparatorLicensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine
Receives: Biological: Pertussis containing vaccine
Recombinant acellular pertussis (aP) vaccineExperimentalLicensed recombinant acellular pertussis (aP) vaccine (containing 5 µg of PTgen and 5 µg of FHA)
Receives: Biological: Pertussis containing vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and percentages of participants reporting any adverse drug reactions (ADRs)

    Incidence and percentages of participants reporting any adverse drug reactions (ADRs) within 28 days following a single booster dose of recombinant acellular pertussis (aP) vaccine.

    Measured: 28 days after vaccination

Secondary outcomes (4)

  1. Incidence, severity, and percentages of participants reporting adverse events (AEs)

    Incidence, severity, and percentages of participants reporting adverse events (AEs) during 28 days following vaccination

    Measured: 28 days following vaccination

  2. Incidence, severity, and percentages of participants reporting serious adverse events (SAEs)

    Incidence, severity, and percentages of participants reporting serious adverse events (SAEs) during the study period.

    Measured: 28 days after vaccination

  3. Duration of AEs, ADRs, and SAEs

    Duration of AEs, ADRs, and SAEs, categorized by severity and MedDRA System Organ Class.

    Measured: 28 days after vaccination

  4. Categorization of ADRs by System Organ Class and Preferred Term

    Categorization of ADRs by System Organ Class and Preferred Term, based on MedDRA coding.

    Measured: 28 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start8 Feb 2025
  3. Primary completion4 Apr 2025
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06798831
Sponsor's protocol ID
APV301
Other IDs
BioNet-Asia.Co.,Ltd.
Acronym
PertaSafe
Status last verified
Sep 2025
First submitted
23 Jan 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pertussis containing vaccine in people with Pertussis Vaccine, run by BioNet-Asia Co., Ltd. at 3 sites 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 6 inclusion and 16 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 3 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Incidence and percentages of participants reporting any adverse drug reactions (ADRs) (time frame: 28 days after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06798831.

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.

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