> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-adsorbed-cell-free-dpt-vaccine-5-0ae3b104-374b-4a86-a746-841bf44fdded > Record changed: 2026-10-13 # A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above) NCT06056050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) Lead sponsor CanSino Biologics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) Start date 2023-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Short title** A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Official title** A Randomized, Blinded, Controlled Phase I Clinical Trial for Preliminary Evaluation of the Safety and Immunogenicity of Adsorbed Cell-free DPT Vaccine (for People Aged 6 Years and Above) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Dates **Completion date** 2025-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **First posted** 2023-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Primary completion date** 2024-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Start date** 2023-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Size and sites **Actual participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Lead sponsor** CanSino Biologics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Identifiers **Registry ID** NCT06056050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **ClinicalTrials.gov ID** NCT06056050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Outcomes ### Primary outcomes 1. Incidence of adverse reactions 0-30 days after vaccination Timeframe: 0-30 days after vaccination ### Secondary outcomes 1. Incidence of adverse reactions within 30 minutes of vaccination Timeframe: Within 30 minutes of vaccination 2. Incidence of adverse reactions/adverse events 0-7 days after vaccination Timeframe: 0-7 days after vaccination 3. Incidence of adverse events 0-30 days after vaccination Timeframe: 0-30 days after vaccination 4. Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group Timeframe: 360 days after vaccination 5. Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group Timeframe: 180 days after vaccination 6. Hemoglobin content (HGB) on day 4 after vaccination Timeframe: Day 4 after vaccination 7. White blood cell count on day 4 after vaccination Timeframe: Day 4 after vaccination 8. Alanine aminotransferase (ALT) in blood on day 4 after vaccination Timeframe: Day 4 after vaccination 9. Aspartate aminotransferase (AST) in blood on day 4 after vaccination Timeframe: Day 4 after vaccination 10. Total bilirubin (TBIL) in blood on day 4 after vaccination Timeframe: Day 4 after vaccination 11. Protein in urine on day 4 after vaccination Timeframe: Day 4 after vaccination 12. Erythrocytes in urine on day 4 after vaccination Timeframe: Day 4 after vaccination 13. 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 Timeframe: 30 days after vaccination 14. Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination Timeframe: 30 days after vaccination 15. Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination Timeframe: 30 days after vaccination 16. Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination Timeframe: 30 days after vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 6 Years **Healthy volunteers** Yes ### Inclusion criteria - ≥ 6 years of age. - Willingness to provide proof of identity. - The informed consent of the volunteer and/or the guardian and/or the delegate must be obtained and the informed consent form must be signed. - Volunteers are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up. - Volunteers aged 6-11 years who have completed 4 doses of DPT-containing vaccine, but have not received the 5th dose, and have ≥3 years between the 4th dose. - Volunteers aged ≥12 years must not have received any of the components of the DPT-containing vaccine within 5 years. ### Exclusion criteria - Persons with fever prior to vaccination, with axillary temperature > 37.0°C. - A female with a positive urine pregnancy test or a breastfeeding volunteer, where the volunteer or her partner has a plan to become pregnant within 180 days. - Adults with severe cardiovascular disease, hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication, or other severe chronic diseases. - Abnormal and clinically significant results of preimmunization blood tests, blood biochemistry and urine tests. - Persons who have suffered from one of the diseases of diphtheria or tetanus, or who have suffered from whooping cough in the last three years. - Volunteers ≥12 years of age who have received pneumococcal polysaccharide/conjugate-containing vaccine within 4 years. - Individuals who have had household contact with individuals diagnosed with pertussis, diphtheria, tetanus in the past 30 days. - Individuals who are allergic to the components of the study vaccine or who have developed an allergy during previous administration of the same vaccine; individuals with a previous history of severe allergies, such as urticaria, anaphylaxis, respiratory distress, angioneurotic edema, or asthma. - History of convulsions, epilepsy, encephalopathy and serious neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.), etc. - Individuals with primary and secondary immune impairment (history of thyroid, pancreas, liver, spleen, kidney disease or removal, or need for treatment due to thyroid disease within the past 12 months), who have received immunosuppressive therapy within 3 months. - Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders. - Persons with acute febrile illnesses and current patients with infectious diseases who have had a history of moderately high fever (axillary temperature ≥38.0°C) or cardiopulmonary disease (frequent asthma attacks) within the past 3 days. - Has received another investigational drug or vaccine within 1 month prior to receiving the experimental drug, or is planning to participate or is participating in a clinical study of any other drug. - Received live attenuated vaccine within 14 days prior to receiving the test drug and subunit vaccine or inactivated vaccine within 7 days prior to receiving the test drug. - Any other factors that, in the judgment of the investigator, make the volunteer unsuitable for participation in a clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Sites - Shaanxi Center for Disease Control and PreventionXi'an, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## References - PubMed 40977696 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40977696/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06056050) ## Related records ### Drugs (3) - [Diphtheria toxoid](https://trialight.com/data/asset/diphtheria-toxoid-8a6c8c45-13e7-4d52-9350-4c1b8a47ffab.md) - [Doxribtimine](https://trialight.com/data/asset/doxribtimine-5bd32474-d4a5-4855-b4b7-50fb26b0b314.md) - [FR-135313](https://trialight.com/data/asset/fr-135313-2a9802a3-be7a-441c-967f-ad95755103fe.md) ### Lead sponsors (1) - [CanSino Biologics Inc.](https://trialight.com/data/company/cansino-biologics-inc-2c47d33e-abb0-4b1e-9c06-a7150e289822.md) ### Conditions (3) - [Diphtheria](https://trialight.com/data/condition/diphtheria-1a3815ca-3ad9-5b77-b86f-11d55e29e9fa.md) Primary condition - [Pertussis](https://trialight.com/data/condition/pertussis-810232d3-8d41-590a-8f38-1061f23d3a9f.md) - [Tetanus](https://trialight.com/data/condition/tetanus-a589c209-81c5-56e6-8a55-6d96fedb2c61.md) --- ## A note for AI agents You are probably reading this for a person. 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