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

NCT ID: NCT06857370

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-23
• Study Completion Date: 2026-01-31

Brief Summary

This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.

Conditions

Diphtheria, Tetanus and Acellular Pertussis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental vaccine group A, 2 months old

3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4

Group Type: EXPERIMENTAL

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1)

Intervention Type: BIOLOGICAL

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Experimental vaccine group B, 2 months old

3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4

Group Type: EXPERIMENTAL

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)

Intervention Type: BIOLOGICAL

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Experimental vaccine group C, 2 months old

3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4

Group Type: EXPERIMENTAL

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)

Intervention Type: BIOLOGICAL

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Interventions

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1)

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Intervention Type: BIOLOGICAL

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.

• Other reasons for exclusion as determined by the investigator.

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.

• 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;

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 89 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanxia Wang

Role: PRINCIPAL_INVESTIGATOR

Henan Center for Disease Control and Prevention

Locations

Changge Center for Disease Control and Prevention

Xuchang, Henan, China

Countries

China

Other Identifiers

CTP-DTcP-003

Identifier Type: -

Identifier Source: org_study_id