A Phase 3 interventional study of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed and Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed in Whooping Cough, Diphtheria and Tetanus, sponsored by China National Biotec Group Company Limited. Active, not recruiting at 4 sites in China. Open to participants aged 2 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by China National Biotec Group Company Limited (part of Sinopharm) · Phase 3, Interventional, and Prevention
Among 20 studies in Whooping Cough with a site in China — 7 open to participants now, 8 under way, 2 of them phase 3. Whooping Cough · China.
Among the 20 studies in Whooping Cough with a site in China, this one has the largest enrollment of the 17 interventional ones, is one of 3 that started in 2021, is one of 6 in phase 3, and was the 11th registered.
290 studies on the registry are indexed under Whooping Cough; 23 are open to participants now.
This study's enrollment of 2,898 is above the median of 400 across 228 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →7 of the 20 studies in Whooping Cough with a site in China are open now, in 1 country. Each count lists the studies.
Of the 13 Whooping Cough studies recruiting now, 2 (15%) set no upper age limit and 10 (77%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 2 Months to 3 Months · all sexes · healthy volunteers too.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2021.
Median enrollment 792 across the 17 interventional studies, 500 across the 3 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
11 of 20 have an industry lead sponsor. The 9 most frequent:
China National Biotec Group Company Limited is the lead sponsor of 37 studies on the registry; 2 are open to participants now.
China National Biotec Group Company Limited has 1 study filed under Whooping Cough — fewer than ten, so there is no comparison to draw.
1 of the studies in Whooping Cough with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07891104Institute of Medical Biology, Chinese Academy of Medical SciencesA Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed | 2027-08-16 |
Among the 20 studies in Whooping Cough with a site in China, from their registry updates:
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 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
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
Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
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
Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
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
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
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
Biological: Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
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
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization
Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Intramuscular injection
Also known as: DTacP
Intramuscular injection
Also known as: DTaP
Drug page: Pentavac
Intramuscular injection
Also known as: PENTAXIM
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.
Time frame: 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
Time frame: 1 month after Dose 3
Percentage of participants reporting local reactions
As elicited by investigational site staff
Time frame: Day 7 post-each dose
Percentage of participants reporting systemic events
As elicited by investigational site staff
Time frame: Day 7 post-each dose
Percentage of participants reporting adverse events
As elicited by investigational site staff
Time frame: within 30 days post-each dose
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
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
As measured at the central laboratory
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
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
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
As measured at the central laboratory
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
eropositivity is defined as antibody concentrations ≥ protective antibody concentration
Time frame: Day 30 post-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
Time frame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
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
Time frame: 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5
Plan to share: No — In order to maintain the rights of the subject, do not open the IPD
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Jan 2024, 27 months.
Of 26 industry-sponsored phase 3 interventional studies under Whooping Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's 27 months is above that.
Counting every sponsor, half of 26 studies reached it within 15 months; a quarter within 7 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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China National Biotec Group Company Limited →