A Phase 2/3 interventional study of Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (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 2026-08-26.
Sponsored by CanSino Biologics Inc. · Phase 2/3, Interventional, and Prevention
This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 1,820 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.
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.
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.
One dose of Tdcp on Day 0
Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))
One dose of PPV23 on Day 0
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)
One dose of Tdcp on Day 0
Biological: Tdcp
One dose of PPV23 on Day 0
Biological: PPV23
One dose of Tdcp on Day 0
Biological: Tdcp
One dose of PPV23 on Day 0
Biological: PPV23
One dose of Tdcp on Day 0
Biological: Tdcp
One dose of PPV23 on Day 0
Biological: PPV23
One dose of Tdcp on Day 0
Biological: Tdcp
One dose of DTaP on Day 0
Biological: Diphtheria-tetanus-acellular pertussis vaccine (DTaP)
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of DTaP vaccine (0.5ml) on day 0
Phase II: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: Pre-vaccination and 30 days post-vaccination
Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml
Time frame: 30 days after vaccination
Phase III: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
Phase II: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase II: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase II: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase II: Incidence of serious stadverse events
Time frame: Within 6 months of vaccination
Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies
Time frame: 30 days after vaccination
Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase III: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase III: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase III: Incidence of SAEs in subjects aged 7 years and older
Time frame: Within 6 months of vaccination
Phase III: Incidence of SAEs in subjects aged 6 years
Time frame: Within 12 months of vaccination
Seropositivity rates of antibodies against PT, FHA, PRN, FIM2&3, DT, and TT in the immunopersistence subgroup
Time frame: 12 months, 3 years, and 5 years post-vaccination
Geometric mean concentrations (GMC) of antibodies against PT, FHA, PRN, FIM2&3, DT, and TT in the immunopersistence subgroup
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-PRN antibodies ≥ 5 IU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-FIM2&3 antibodies ≥ 5 EU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-PRN antibodies ≥ 10 IU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-FIM2&3 antibodies ≥ 10 EU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-PRN antibodies ≥ 20 IU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-FIM2 & 3 antibodies ≥ 20 EU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-DT antibodies ≥ 0.1 IU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-TT antibodies ≥ 0.1 IU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
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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Studies of the drug tested here: 23-valent pneumococcal capsular polysaccharide vaccine