RecruitingNCT07891104Updated Oct 23, 2026

A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed

A Phase 1/2 interventional study of Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed and Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine in Diphtheria, Pertussis and Tetanus, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Recruiting at 3 sites in China. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences · Phase 1/2, Interventional, and Prevention

Updated Oct 23, 2026Newly registeredGo to Updates ↓

Phase: Phase 1/2
Study type: Interventional
Enrollment: 380
Allocation: Randomized
Ages: 2 Months to 6 Years
Sex: All

Study 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.

Conditions studied

Diphtheria
Pertussis
Tetanus
Poliomyelitis
Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

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In context

Diphtheria

270 studies on the registry are indexed under Diphtheria; 17 are open to participants now.

This study's planned enrollment of 380 is below the median of 440 across 243 interventional studies indexed under Diphtheria.

Browse Diphtheria studies →

Lead sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Months to 6 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 380 participants (estimated)

Study arms

Experimental
Experimental Vaccine
Participants aged 2 months to 6 years
Biological: Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Active comparator
DTacP controlled group
Participants aged 2 months to 6 years
Biological: Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine
Active comparator
DTacP+sIPV controlled group
Participants aged 2 to 24 months
Biological: Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Interventions

BiologicalDiphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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.
BiologicalDiphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine
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.
BiologicalDiphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains
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.

What researchers measure

Primary outcomes

Safety index - incidence of adverse events
Incidence of adverse events after each dose vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 30 after basic immunization

Secondary outcomes

Safety index - incidence of serious adverse events
Incidence of serious adverse events after vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 30 after booster immunization

Study locations

1 of 3 sites recruiting

Hechuan District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality, China
- Wenwen Li · Contact · hcjkxmb@163.com · 023-42722032
Recruiting
Jiulongpo District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality, China
- Yulin Mou · Contact · 451362206@qq.com · 023-89123801
Not yet recruiting
Yongchuan District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality, China
- Liang Chen · Contact · 546312971@qq.com · 023-49807161
Not yet recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 10, 2026
First posted: Oct 23, 2026
StartActual: Oct 11, 2026
Primary completionEst.: Aug 16, 2027
CompletionEst.: Sep 25, 2028
Last update: Oct 23, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 23, 2026

Show all 1 update

Oct 23, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07891104
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Responsible party: Sponsor
First posted: Oct 23, 2026
Start date: Oct 11, 2026
Primary completion: Aug 16, 2027 (estimated)
Completion: Sep 25, 2028 (estimated)
Last update: Oct 23, 2026

Study contacts

Jingsi Yang

Contact

yjs@imbcams.com.cn

0871-68334551 ext. +86

Wenge Tang

principal investigator · Chongqing Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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