A Phase 1 interventional study of Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp) and 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23） in Diphtheria, Tetanus and Pertussis, sponsored by CanSino Biologics Inc.. Completed at 1 site in China. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by CanSino Biologics Inc. · Phase 1, Interventional, and Prevention
Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.
The vaccines used in China's immunization program for the prevention of pertussis, tetanus and diphtheria include the adsorbed cell-free diphtheria-tetanus-acellular pertussis vaccine (DTaP) and the diphtheria-tetanus-acellular tetanus vaccine (DT) and tetanus vaccine. Among them, DTaP vaccination is for children from 3 months of age to 6 years of age, with one dose each at 3, 4, 5, and 18 months of age; DT vaccination is for children under 12 years of age, with one dose at 6 weeks of age after completing four doses of DTaP vaccination. However, infant and young child vaccination is no longer sufficient to prevent the threat of this disease, mainly due to the rapid decay of immune protection in adolescents and adults, and infections in this population, which are the main source of infection leading to infection in infants and young children, have been a number of new preventive strategies are being evaluated.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 180 is below 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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 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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
1 dose of Tdcp vaccine
Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
1 dose of PPV23 vaccine
Biological: 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）
1 dose of Tdcp vaccine
Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
1 dose of PPV23 vaccine
Biological: 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）
1 dose of Tdcp vaccine
Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
1 dose of DT vaccine
Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)
1 dose of Tdcp vaccine (0.5ml) on Day 0
1 dose of PPV23 vaccine (0.5ml) on Day 0
1 dose of DT vaccine (0.5ml) on Day 0
Incidence of adverse reactions 0-30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of adverse reactions within 30 minutes of vaccination
Time frame: Within 30 minutes of vaccination
Incidence of adverse reactions/adverse events 0-7 days after vaccination
Time frame: 0-7 days after vaccination
Incidence of adverse events 0-30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group
Time frame: 360 days after vaccination
Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group
Time frame: 180 days after vaccination
Hemoglobin content (HGB) on day 4 after vaccination
Time frame: Day 4 after vaccination
White blood cell count on day 4 after vaccination
Time frame: Day 4 after vaccination
Alanine aminotransferase (ALT) in blood on day 4 after vaccination
Time frame: Day 4 after vaccination
Aspartate aminotransferase (AST) in blood on day 4 after vaccination
Time frame: Day 4 after vaccination
Total bilirubin (TBIL) in blood on day 4 after vaccination
Time frame: Day 4 after vaccination
Protein in urine on day 4 after vaccination
Time frame: Day 4 after vaccination
Erythrocytes in urine on day 4 after vaccination
Time frame: Day 4 after vaccination
Antibody Positive Turnover of Serum Anti-Diphtheria Toxoid(DT), Tetanus Toxoid(TT), Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), FIM bridal agglutinogens(FIM) 2&3 at 30 days after vaccination
Time frame: 30 days after vaccination
Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Time frame: 30 days after vaccination
Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Time frame: 30 days after vaccination
Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination
Time frame: 30 days after vaccination
Ran from Dec 2023 to primary completion in Apr 2024, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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