Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine
A Randomized, Double-Blind, Parallel-Controlled Phase I/II Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above
1 other identifier
interventional
660
1 country
1
Brief Summary
This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
February 18, 2026
February 1, 2026
6 months
February 11, 2026
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Safety index - incidence of adverse events
Incidence of adverse events after vaccination
0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination
Immunogenicity index - Geometric Mean Concentration (GMC)
The GMC of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Day 30 after vaccination
Immunogenicity index - Seropositive Rate
The seropositve rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Day 30 after vaccination
Secondary Outcomes (3)
Safety index - incidence of serious adverse events
From vaccination to 12 months after vaccination
Immunogenicity index - Seroconversion Rate
Between baseline and Day 30 after vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
Between baseline and Day 30 after vaccination
Study Arms (4)
low-dose experimental group
EXPERIMENTALParticipants aged 6 years and above
high-dose experimental group
EXPERIMENTALParticipants aged 6 years
DTaP controlled group
ACTIVE COMPARATORParticipants aged 6 years
PPV23 controlled group
PLACEBO COMPARATORParticipants aged 7 years and above
Interventions
Low-dose vaccine, 0.5ml/dose, one dose at Day 0
High-dose vaccine, 0.5ml/dose, one dose at Day 0
DTaP controlled vaccine, 0.5ml/dose, one dose at Day 0
PPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0
Eligibility Criteria
You may qualify if:
- Age Requirement: volunteers aged 6 years and above
- Provision of Legal Identification: volunteers 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.
You may not qualify if:
- Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.
- Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.
- Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).
- Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.
- Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or those who have experienced paroxysmal spasmodic coughing for at least 14 days without fever within 5 years, and for which no other specific cause (such as influenza) can be identified, and have a history of exposure to pertussis or contact with confirmed cases.
- Subjects who have been diagnosed with serious diseases that may interfere with the conduct or completion of the trial.
- Subjects who have shown allergic reactions to any component of the trial vaccine (such as aluminum adjuvant) before enrollment, or have experienced severe allergic reactions, suspected severe allergies (such as Arthus reaction, anaphylactic shock, laryngeal edema, allergic purpura, local allergic necrotic reaction, etc.) or other serious adverse reactions (such as thrombocytopenic purpura, breathing difficulties, angioneurotic edema, widespread rash, brachial plexus neuritis, etc.) to any vaccine or drug before enrollment.
- Subjects who have experienced convulsions, epilepsy, mental disorders before enrollment, or have a family history of such diseases, or have had severe brain diseases (such as hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumors, cerebral infarction, stroke, etc.) before enrollment.
- Subjects with coagulation disorders (such as deficiency of coagulation factors, coagulation diseases, and platelet abnormalities), or a history of bleeding disorders, or those with hereditary bleeding tendencies.
- Individuals with primary or secondary immune function impairment, or those who have been receiving immunosuppressive therapy for a long time (such as long-term systemic glucocorticoid treatment, for example, using prednisone or similar drugs for two weeks or more continuously, but local use such as ointments, eye drops, inhalants or nasal sprays is allowed), or those who plan to use it during the trial.
- Subjects who have had their spleen removed or undergone partial or complete removal of other vital organs (such as the liver, kidneys, lungs, pancreas, thyroid, stomach, intestines, and other vital organs) due to any cause.
- Subjects who have donated blood or lost blood (≥ 400 ml) within 6 months before enrollment, received blood transfusion or used blood products, or plan to receive blood transfusion or use blood products during the trial.
- Any investigational or unregistered products (drugs, biologics or devices) were used within 6 months before enrollment, or the subject plans to participate in or is currently participating in any clinical trial.
- Subjects who may be unable to follow the trial procedures, abide by the agreement, or plan to permanently relocate from this area during the trial period, or be away from the local area for a long time during the scheduled visits.
- Subjects deemed by the investigator to be unsuitable for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangjin District Center for Disease Control and Prevention
Chongqing, Chongqing Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiawei Xu
Chongqing Center for Disease Control and Prevention
Central Study Contacts
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
February 11, 2026
First Posted
February 18, 2026
Study Start
March 12, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
July 31, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share