DiphtheriaPhase 1/2NCT07891104
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
A Phase 1/2 study testing Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed, Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine and Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains in people with Diphtheria and Pertussis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 3 sites in China.
Trial summary
This is a randomized, positive-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed in subjects aged 2 Months to 6 Years. Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Pertussis, Tetanus
- What is being tested?
- Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed, Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine and Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 3 sitesChina
- Study dates
- 11 Oct 2026to 25 Sep 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age Requirement: volunteers aged 4-6 years, 18-24 months, and 2 months.
- History of preventive inoculation: (1)children aged 4-6 years who have completed immunization with 4 doses of DTP vaccine or another combination vaccine containing DTP antigen components in accordance with the National Immunization Program, and who have not yet received the fifth dose of DTP vaccine; (2)children aged 18-24 months have completed basic immunization with DTP vaccine or another combination vaccine containing DTP antigen components (3 doses) and basic immunization with poliovirus vaccine (3 doses) in accordance with the National Immunization Program, and have not yet received a booster dose of DTP vaccine (the 4th dose) or a booster dose of poliovirus vaccine (the 4th dose); (3) infants aged 2 months have not yet received vaccines containing DTP antigen components, vaccines containing poliovirus antigen components, 13-valent pneumococcal polysaccharide conjugate vaccine, haemophilus influenzae type b conjugate vaccine, or group A and C meningococcal and haemophilustype b conjugate vaccine.
- Provision of Legal Identification: participants and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
- 2 months old: full term infant (37 weeks ≤ gestational age < 42 weeks) with a birth weight ≥ 2500 g.
Who cannot join
- axillary temperature > 37.3℃.
- History of pertussis, tetanus, diphtheria, or poliomyelitis.
- History of abnormal labor and delivery at birth (dystocia or instrumental delivery), asphyxia, or neurological impairment, or history of clinically diagnosed pathological jaundice (applicable only to participants aged 2 months or 18-24 months).
- Allergy to any component of the investigational vaccine (such as aluminum hydroxide), or a history of severe allergic reactions to any vaccine or drug, or other serious adverse reactions, such as anaphylactic shock, generalized diffuse mucocutaneous angioedema, laryngeal obstruction caused by angioedema, or other life-threatening adverse reactions.
- Receipt of any inactivated vaccine or subunit vaccine within 7 days before administration of the investigational vaccine, or any live attenuated vaccine within 14 days before administration of the investigational vaccine.
- Acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before receipt of the first dose of the investigational vaccine.
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- Use of antipyretic analgesic, anti-allergic, or antiviral drugs within 3 days before receipt of the first dose of the investigational vaccine.
- History of seizures, epilepsy, encephalopathy, or psychiatric disorders, or a family history of any of the above conditions.
- Severe congenital malformations, developmental disorders, or congenital diseases , or other clinically diagnosed severe chronic diseases, including but not limited to severe diseases of the neurological, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, or a history of malignant tumors.
- Contraindications to intramuscular injection or venipuncture, such as hereditary bleeding tendency or coagulation disorders, history of bleeding disorders, or diagnosed thrombocytopenia.
- Infectious diseases that may interfere with the conduct of the trial.
- Surgical splenectomy for any reason, splenic dysfunction, or asplenia due to any cause, or resection or partial resection of other vital organs.
- Blood loss (≥400 mL), receipt of a blood transfusion, or use of blood products within 3 months before receiving the first dose of the investigational vaccine.
- Receipt of immunosuppressive therapy within 6 months before receiving the first dose of the investigational vaccine.
- Participation in or plan to participate in any clinical trial.
- Laboratory test results are abnormal and have clinical significance in 18 months to 6 years.
- Unsuitable for participation in the trial, as judged by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hechuan District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality
Wenwen Li, 023-42722032 ext. +86, hcjkxmb@163.com
- Not yet recruiting
Jiulongpo District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality
Yulin Mou, 023-89123801 ext. +86, 451362206@qq.com
- Not yet recruiting
Yongchuan District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality
Liang Chen, 023-49807161 ext. +86, 546312971@qq.com
About this study
Official title: A Randomized, Positive-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed in Individuals Aged 2 Months to 6 Years
This is a randomized, positive-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed in subjects aged 2 Months to 6 Years.
- Conditions
- Diphtheria, Pertussis, Tetanus, Poliomyelitis, Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
- Being tested
- Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed, Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine, Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains
- Medical subject headings
- Diphtheria, Whooping Cough, Tetanus, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine AdsorbedBiological
Dosage and immunization schedule: 0.5 mL/dose. 18 months to 6 years: one dose at Day 0. 2 months: three doses for basic immunization at 2, 3, and 4 months of age, or at 2, 4, and 6 months of age, and one dose for booster immunization at 18 to 24 months of age.
Diphtheria, Tetanus and Acellular Component Pertussis Combined VaccineBiological
Dosage and immunization schedule: 0.5 mL/dose.18 months to 6 years: one dose at Day 0. 2 months: three doses for basic immunization at 3, 4, and 5 months of age, or at 2, 3, and 4 months of age, or at 2, 4, and 6 months of age, and one dose for booster immunization at 18 to 24 months of age.
Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin StrainsBiological
Dosage and immunization schedule: 0.5 mL/dose.18 to 24 months : one dose at Day 0. 2 months: three doses for basic immunization at 2, 4, and 6 months of age, and one dose for booster immunization at 18 to 24 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Vaccine | Experimental | Participants aged 2 months to 6 years Receives: Biological: Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed |
| DTacP controlled group | Active comparator | Participants aged 2 months to 6 years Receives: Biological: Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine |
| DTacP+sIPV controlled group | Active comparator | Participants aged 2 to 24 months Receives: Biological: Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety index - incidence of adverse events
Incidence of adverse events after each dose vaccination
Measured: 0- 30 minutes/Day 0 to 7 days/Day 0 to 30 days after each dose
Immunogenicity index-Seroconversion rate
The seroconversion rate of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies, and type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after basic immunization
Measured: Day 30 after basic immunization
Immunogenicity index-Seropositive rate
The seropositive rate of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies, and type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after basic immunization
Measured: Day 30 after basic immunization
Immunogenicity index-Geometric mean concentration (GMC)
The GMC of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies 30 days after basic immunization
Measured: Day 30 after basic immunization
Immunogenicity index-Geometric mean titer (GMT)
The GMT of type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after basic immunization
Measured: Day 30 after basic immunization
Immunogenicity index-Geometric mean fold increases (GMFI)
The GMFI of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies, and type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after basic immunization
Measured: Day 30 after basic immunization
Secondary outcomes (6)
Safety index - incidence of serious adverse events
Incidence of serious adverse events after vaccination
Measured: From the beginning of the vaccination up to 12 months after the last vaccination completed
Immunogenicity index-Seroconversion rate
The seroconversion rate of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies, and type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after booster immunization
Measured: Day 30 after booster immunization
Immunogenicity index- Seropositive rate
The seropositive rate of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies, and type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after booster immunization
Measured: Day 30 after booster immunization
Immunogenicity index-Geometric mean concentration (GMC)
The GMC of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies 30 days after booster immunization
Measured: Day 30 after booster immunization
Immunogenicity index-Geometric mean titer (GMT)
The GMT of type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after booster immunization
Measured: Day 30 after booster immunization
Immunogenicity index-Geometric mean fold increases (GMFI)
The GMFI of anti-DT, anti-TT, anti-PT, anti-PRN, anti-FHA antibodies, and type I, type II, type III anti-poliovirus neutrilizing antibodies 30 days after booster immunization
Measured: Day 30 after booster immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start11 Oct 2026
- Primary completion16 Aug 2027 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenge Tang, Principal investigator, Chongqing Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891104
- Sponsor's protocol ID
- 20200620
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No