Whooping CoughPhase 3DTaPNCT05091619

A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

A Phase 3 study testing Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine in people with Whooping Cough and Diphtheria, run by China National Biotec Group Company Limited at 4 sites in China.

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

The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3… Read more about this study

Who is it for?: Ages 2 to 3 monthsHealthy volunteers can take part
Conditions the study is for: Whooping Cough, Diphtheria, Tetanus
What is being tested?: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,898 participants
Where: 4 sitesChina
Study dates: 22 Oct 2021to 22 Sep 2027
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 2 to 3 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ；
Willing to provide proof of identity
Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3）；
Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan.

Who cannot join

With temperature >37.0°C on axillary setting before vacciation;
With a medical history of diphtheria, pertussis or tetanus;
Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days;
Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight< <2500g);
History of dystocia, suffocation rescue, neurological damage;
With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.

Show all 15Show fewer

History of epilepsy, convulsions or convulsions, or have a family history of mental illness;
History of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy);
Had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days);
History of severe allergic reactions to vaccination, such as difficulty breathing, urticaria;
Any prior administration of blood products in last 3 month;
Any prior administration of attenuated live vaccine in last 14 days;
Any prior administration of subunit or inactivated vaccines in last 7 days;
Plans to participate in or is participating in any other drug clinical study;
Has any other factors judged by investigators that make them unfit to participate in the clinical trial

Trial locations and contacts

4 sites in 1 country.

China4 sites

Neihuang County Center for Disease Control and Prevention
Anyang, Henan, 456300
Wen County Center for Disease Control and Prevention
Jiaozuo, Henan, 454850
Wuyang County Center for Disease Control and Prevention
Luohe, Henan, 462400
Yanjin County Center for Disease Control and Prevention
Xinxiang, Henan, 453200

Other trials in China

About this study

Official title: A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months

PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM)，compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence.

PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.

Conditions: Whooping Cough, Diphtheria, Tetanus
Being tested: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed, Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Medical subject headings: Whooping Cough, Diphtheria, Tetanus

What participants receive

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

Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, AdsorbedBiological
Also called DTacP
Intramuscular injection
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, AdsorbedBiological
Also called DTaP
Intramuscular injection
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccineBiological
Also called PENTAXIM
Intramuscular injection

Study groups in NCT05091619
Study group	Role	What they receive
A1	Experimental	subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
A2	Active comparator	subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
A3	Active comparator	subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old Receives: Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
B1	Experimental	subjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
B2	Active comparator	subjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
B3	Experimental	subjects aged 2 months receive 3 doses of vaccines with a interval of 2 months for primary immunization, and a booster dose at 18 month old Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
C1	Experimental	subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
C2	Experimental	subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
C3	Experimental	subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization Receives: Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

What is being measured

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

The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is < protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration.
Measured: 1 month after Dose 3
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
Measured: 1 month after Dose 3
Percentage of participants reporting local reactions
As elicited by investigational site staff
Measured: Day 7 post-each dose
Percentage of participants reporting systemic events
As elicited by investigational site staff
Measured: Day 7 post-each dose
Percentage of participants reporting adverse events
As elicited by investigational site staff
Measured: within 30 days post-each dose

Secondary outcomes (5)

The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration
Measured: Day 30 post-dose 3
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
Measured: before dose 4 at 18 months old(booster)
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
Measured: before dose 4 at 18 months old(booster)
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
As measured at the central laboratory
Measured: Day 30 post-dose 4 at 18 months old(booster)
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
eropositivity is defined as antibody concentrations ≥ protective antibody concentration
Measured: Day 30 post-dose 4 at 18 months old(booster)

Timeline

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

22 Oct 202122 Sep 2027

First posted25 Oct 2021
Study start22 Oct 2021
Primary completion22 Jan 2024
Study completion22 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Whooping CoughStudies 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: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 2,898 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05091619
Sponsor's protocol ID: 2016L10765-2
Acronym: DTaP
Status last verified: Nov 2024
First submitted: 21 Oct 2021
Last updated: 15 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: In order to maintain the rights of the subject, do not open the IPD

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

All Whooping Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months
ClinicalTrials.gov ID: NCT05091619
Acronym / sponsor ID: DTaP / 2016L10765-2
Conditions: Whooping Cough, Diphtheria, Tetanus
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,898 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Beijing Institute of Biological Products Co Ltd.
Study start: 22 Oct 2021 (actual)
Primary completion: 22 Jan 2024 (actual)
Study completion: 22 Sep 2027 (estimated)
First posted: 25 Oct 2021 (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.

PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
A1	Experimental	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbedsubjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
A2	Active comparator	Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbedsubjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
A3	Active comparator	Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccinesubjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
B1	Experimental	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbedsubjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
B2	Active comparator	Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbedsubjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
B3	Experimental	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbedsubjects aged 2 months receive 3 doses of vaccines with a interval of 2 months for primary immunization, and a booster dose at 18 month old
C1	Experimental	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbedsubjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
C2	Experimental	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbedsubjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
C3	Experimental	Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbedsubjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization

Who may qualify

Ages: 2 to 3 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ；
Willing to provide proof of identity
Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3）；
Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan.

Key exclusion criteria (15 listed)

With temperature >37.0°C on axillary setting before vacciation;
With a medical history of diphtheria, pertussis or tetanus;
Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days;
Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight< <2500g);
History of dystocia, suffocation rescue, neurological damage;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, AdsorbedAlso: DTacPIntramuscular injection	Biological	A1, B1, B3, C1, C2, C3
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, AdsorbedAlso: DTaPIntramuscular injection	Biological	A2, B2
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccineAlso: PENTAXIMIntramuscular injection	Biological	A3

Primary outcome

The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: 1 month after Dose 3
seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is < protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration.
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: 1 month after Dose 3
As measured at the central laboratory
Percentage of participants reporting local reactions
Time frame: Day 7 post-each dose
As elicited by investigational site staff
Percentage of participants reporting systemic events
Time frame: Day 7 post-each dose
As elicited by investigational site staff
Percentage of participants reporting adverse events
Time frame: within 30 days post-each dose
As elicited by investigational site staff

5 secondary outcomes

The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: Day 30 post-dose 3
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: before dose 4 at 18 months old(booster)
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: before dose 4 at 18 months old(booster)
Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: Day 30 post-dose 4 at 18 months old(booster)
The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody
Time frame: Day 30 post-dose 4 at 18 months old(booster)

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 15 Sep 2025.
Individual participant dataSharing planned: No. In order to maintain the rights of the subject, do not open the IPD

Related trials for Whooping Cough

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

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.

Lili Huang principal investigator

Henan Province Center for Disease Control and Prevention

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 15 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody (time frame: 1 month after Dose 3). The study lists 5 primary outcomes in all. 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 NCT05091619.

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 15 Sep 2025.