Testing a new combined vaccine for diphtheria, tetanus, and pertussis in infants

Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine

This study is testing a new combined vaccine for diphtheria, tetanus, and whooping cough in infants to see if it works well and is safe.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 60 Days to 89 Days
• Sex: All
• Sponsor: CanSino Biologics Inc. (Industry-sponsored)
• Locations: 1 site (Xuchang, Henan)
• Trial ID: NCT06857370 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, blinded, peer-controlled study designed to evaluate the inter-lot consistency of a combined vaccine for diphtheria, tetanus, and acellular pertussis (DTcP). Infants aged 2 months will be randomly assigned to receive one of three different batches of the vaccine, with doses administered at 2, 4, and 6 months of age. The study aims to assess the immunogenicity and safety of the vaccine across different lots to ensure consistent efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are infants aged 2 months who have not previously received a DPT vaccine.

Not a fit: Patients who have a history of allergic reactions to vaccines or have previously contracted diphtheria, tetanus, or pertussis may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to a more reliable and effective vaccination option for preventing diphtheria, tetanus, and pertussis in infants.

How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating a promising avenue for immunization.

Eligibility criteria

Inclusion Criteria:

* 2 months of age (60\~89 days), willing to provide identification documents;
* The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical research protocol.

Exclusion Criteria:

First dose exclusion criteria

* Persons who have received a vaccine containing the DPT classified vaccine;
* Premature labor (delivery before 37th week of gestation), low birth weight 60 (birth weight \<2500g);
* Those with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage;
* Who have had one of the pertussis, diphtheria or tetanus diseases;
* Who have had household contact with an individual diagnosed with pertussis, diphtheria, or tetanus disease in the past 30 days;
* Have a history of allergy to vaccines or vaccine components and severe side reactions to vaccines, such as hives, dyspnea, angioneurotic edema, and other allergic reactions;
* Persons with a history of seizures, convulsions, convulsions, or cerebral palsy; or a history or family history of psychiatric illness; or other progressive neurologic disorders;
* Have been diagnosed with an immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), Juvenile Rheumatoid Arthritis ( Juvenile Rheumatoid Arthritis (JRA) or other autoimmune diseases;
* Any condition resulting in absence of spleen, defective spleen function;
* Known or suspected acute illness or severe chronic disease (including: severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignancy, etc.); or in an acute exacerbation of a chronic disease;
* Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
* Immunosuppressive or modifying agents, cytotoxic consecutive therapy for more than 10 days (except inhaled and topical steroids) within 2 months prior to receiving the test vaccine;
* Received blood products (other than hepatitis B immune globulin) within 2 months prior to receiving the test vaccine;
* Participated or planning to participate in any other drug or vaccine clinical study;
* Has received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to receiving the test vaccine;
* Axillary temperature \>37.3°C prior to vaccination;
* Any other factor that, in the investigator's judgment, makes the subject unsuitable for participation in a clinical trial.

Exclusion Criteria for Doses 2,3

* Persons who have had a severe allergic reaction following a previous dose of vaccine;
* Persons with serious adverse reactions causally related to the previous dose of vaccination;
* Those with a newly identified or newly occurring condition after the first dose of vaccination that does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose, as determined by the investigator for continued participation in the study;
* Other reasons for exclusion as determined by the investigator.

Where this trial is running

Xuchang, Henan

• Changge Center for Disease Control and Prevention — Xuchang, Henan, China (Recruiting)

Study contacts

• Principal investigator: Yanxia Wang — Henan Center for Disease Control and Prevention
• Study coordinator: Peng Wan

Conditions Diphtheria, Tetanus and Acellular Pertussis; Vaccine; Three Components; Immunogenicity; Safety; 2 months old