> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/adsorption-of-cell-free-diphtheria-and-tetanus-three-35af1957-37aa-492b-9e51-b7104d92a956 > Record changed: 2026-10-13 # Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial NCT07112144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) Participants 1,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) Lead sponsor Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) Start date 2025-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Title and summary **Summary** The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Short title** Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Official title** Phase III Clinical Trials to Evaluate the Immunogenicity and Safety of Adsorption-free Diphtheria and Tetanus (Three-component) Combined Vaccine in 2-month-old Infants and Young Children Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Dates **Completion date** 2032-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **First posted** 2025-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Registry last updated** 2025-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Primary completion date** 2032-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Start date** 2025-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Size and sites **Participants** 1,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Planned participants** 1,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Lead sponsor** Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Identifiers **Registry ID** NCT07112144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **ClinicalTrials.gov ID** NCT07112144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## 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/NCT07112144) ## Outcomes ### Primary outcomes 1. Immunogenicity Timeframe: day 30 post-primary immunization The geometric mean concentration (GMC) of anti-PT antibody, anti-FHA antibody, anti-PRN antibody, anti-DT antibody, and anti-TT antibody at 30 days post-primary immunization 2. Immunogenicity Timeframe: day 30 post-primary immunization Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-primary immunization ### Secondary outcomes 1. Immunogenicity Timeframe: day 30 post-primary immunization Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-primary immunization 2. Immunogenicity Timeframe: day 30 post-primary immunization Proportions of subjects with anti-PRN antibody levels ≥5, ≥10, and ≥20 IU/mL at day 30 post-primary immunization 3. Immunogenicity Timeframe: day 30 post-fourth booster immunization Geometric mean concentrations (GMCs) of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization 4. Immunogenicity Timeframe: day 30 post-fourth booster immunization Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization 5. Immunogenicity Timeframe: day 30 post-fourth booster immunization Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization 6. Safety Timeframe: At 12 months post-complete vaccination series Incidence of adverse events (AEs) and serious adverse events (SAEs) following each vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 2 Months **Maximum age** 3 Months **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy infants and young children who are permanent residents aged 2 months (60-89 days), and can provide valid identification documents for the subject and their legal guardian; 2. Obtain the informed consent of the subject's legal guardian and sign the informed consent form; 3. The legal guardian of the subject can comply with the requirements of the clinical trial protocol. ### Exclusion criteria 1. History of pertussis, diphtheria, or tetanus; 2. Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days; 3. Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine; 4. Premature infants (born before 37 weeks of gestation), infants with severe abnormal labor processes or a history of asphyxia rescue, or low birth weight infants (<2500g); 5. Axillary temperature >37.0°C on the day of enrollment\*; 6. Severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, or congenital diseases (such as Down syndrome, sickle cell anemia, congenital nervous system diseases, etc.); 7. History of epilepsy, convulsions, or seizures, history of cerebral palsy, or family history of mental illness; 8. Autoimmune diseases or immunodeficiencies (such as perianal abscesses suggesting possible immunodeficiency in infants, human immunodeficiency virus infection, lymphoma, leukemia, etc.), or parents/siblings with autoimmune diseases or immunodeficiencies; 9. Asplenia or splenic dysfunction due to any cause; 10. Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation diseases, platelet abnormalities) or obvious bruising/coagulation disorders that may contraindicate intramuscular injection; 11. History of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reactions), history of severe allergic reactions to any vaccine (widespread urticaria, angioedema, etc.), or allergy to any known component of the test vaccine (pertussis toxoid, filamentous hemagglutinin, 69KD outer membrane protein, diphtheria toxoid, tetanus toxoid, aluminum hydroxide, sodium chloride, sodium hydroxide, etc.); 12. Vaccination with subunit or inactivated vaccines within the past 7 days; vaccination with live attenuated vaccines within the past 14 days\*; 13. Receipt of immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) before enrollment; 14. Receipt of any immunostimulant or immunosuppressant therapy before enrollment (continuous oral administration or infusion for ≥14 days, or topical steroid use \[inhaled, nasal spray, intra-articular, eye drops, ointments, etc.\] exceeding the recommended dosage in the package insert); 15. Suffering from acute illnesses within 3 days before enrollment (acute illness is defined as moderate or severe illness with or without fever)\*; 16. Administration of prophylactic medications (such as antipyretic analgesics, antiallergic drugs, antidiarrheal drugs, etc.) within 3 days before enrollment\*; 17. Known or suspected severe clinically diagnosed diseases (including but not limited to severe diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors); 18. Currently participating in other clinical trials or planning to participate in other trials during the study period; 19. Any other factors that, in the judgment of the researcher, make the subject unsuitable for participating in the clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Sites - Yanshan County Center for Disease Control and PreventionWenshan Zhuang and Miao Autonomous Prefecture, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07112144) ## Related records ### Drugs (1) - Haemophilus influenzae type B strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen ### Collaborators (4) - Guizhou Provincial Center for Disease Control and Prevention - Shaanxi Provincial Center for Disease Control and Prevention - Shandong Provincial Center for Disease Control and Prevention - Yunnan Provincial Center for Disease Control and Prevention ### Lead sponsors (1) - [Changchun BCHT Biotechnology Co.](https://trialight.com/data/company/changchun-bcht-biotechnology-co-2f38a069-5e9a-44f3-93e1-84ac3c4da340.md) --- ## A note for AI agents You are probably reading this for a person. 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