A Phase 3 interventional study of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP) and Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP in Diphtheria, Tetanus and Acellular Pertussis, sponsored by CanSino Biologics Inc.. Active, not recruiting at 1 site in China. Open to participants aged 2 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by CanSino Biologics Inc. · Phase 3, Interventional, and Prevention
The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria，tetanus and acellular pertussis combined vaccine，DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 2,520 is above the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15\~21
Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)
4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15\~21
Biological: Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15\~21
Biological: Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16\~22
Biological: DTcP
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16\~22
Biological: DTaP-IPV-Hib
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16\~22
Biological: DTcP
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Three doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group
Time frame: 30 days after completion of basal immunization
Serum anti-PT, FHA, PRN, DT, TT antibody positive conversion rate, Geometric Mean Concentration(GMC) 30 days after completion of basal immunization in subjects in the 2-month-old group
Time frame: 30 days after completion of basal immunization
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group
Time frame: Within 0-30 days after each dose of vaccination
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group
Time frame: Within 0-30 days after each dose of vaccination
Started Aug 2023 (actual). Primary completion is estimated for Apr 2025, 19 months after the start.
Of 46 industry-sponsored phase 3 interventional studies under Diphtheria, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 21. This study's planned 19 months is above that.
Counting every sponsor, half of 46 studies reached it within 13 months; a quarter within 7 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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