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

NCT07891104 | Recruiting Phase 1 DMC

• 1 other identifier: 20200620
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 3

Brief 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

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

Outcome Measures

Primary Outcomes (6)

• Safety index - incidence of adverse events

  Incidence of adverse events after each dose vaccination

  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

  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

  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

  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

  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

  Day 30 after basic immunization

Secondary Outcomes (6)

• Safety index - incidence of serious adverse events

  From the beginning of the vaccination up to 12 months after the last vaccination completed

• Immunogenicity index-Seroconversion rate

  Day 30 after booster immunization

• Immunogenicity index- Seropositive rate

  Day 30 after booster immunization

• Immunogenicity index-Geometric mean concentration (GMC)

  Day 30 after booster immunization

• Immunogenicity index-Geometric mean titer (GMT)

  Day 30 after booster immunization

Study Arms (3)

Experimental Vaccine

EXPERIMENTAL

Participants aged 2 months to 6 years

Biological: Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed

DTacP controlled group

ACTIVE COMPARATOR

Participants aged 2 months to 6 years

Biological: Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine

DTacP+sIPV controlled group

ACTIVE COMPARATOR

Participants aged 2 to 24 months

Biological: Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Interventions

Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed BIOLOGICAL

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.

Experimental Vaccine

Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine BIOLOGICAL

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.

DTacP controlled group

Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains BIOLOGICAL

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.

DTacP+sIPV controlled group

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• months old: full term infant (37 weeks ≤ gestational age \< 42 weeks) with a birth weight ≥ 2500 g.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead

Study Sites (3)

Hechuan District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China

RECRUITING

Jiulongpo District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Yongchuan District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Diphtheria; Whooping Cough; Tetanus; Poliomyelitis

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Wenge Tang

  Chongqing Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingsi Yang

CONTACT

0871-68334551; yjs@imbcams.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2026
• First Posted: October 23, 2026
• Study Start: October 11, 2026
• Primary Completion (Estimated): August 16, 2027
• Study Completion (Estimated): September 25, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)