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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diphtheria, Tetanus and Acellular Pertussis
• Intervention / Treatment: Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1); Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2); Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)

• Study Type: Interventional
• Enrollment (Actual): 780
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Xuchang, Henan, China, 461500
      • Changge Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental vaccine group A, 2 months old; 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4	Biological: 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
Experimental: Experimental vaccine group B, 2 months old; 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4	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
Experimental: Experimental vaccine group C, 2 months old; 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.	30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.	30 days after vaccination
Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine	30 days after vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.	Within 30 minutes post-vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.	Within 0-7 days
Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects.	Within 0-30 days
Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects.	From first vaccination to 30 days after the third dose

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Investigators: Principal Investigator: Yanxia Wang, Henan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Three Components; 2 months old
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Corynebacterium Infections; Diphtheria; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: CTP-DTcP-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No