A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)

March 14, 2025 updated by: CanSino Biologics Inc.

A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age

The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria，tetanus and acellular pertussis combined vaccine，DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 2 months of age (60~89 days), 3 months of age (90~119 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 study protocol

Exclusion Criteria:

  • Infants 2 months of age who have received a vaccine containing the components of diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine
  • Infants 3 months of age who have received vaccines containing diphtheria, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine or group A, group C meningococcal conjugate vaccine
  • 3-month-old infant vaccinated with IPV
  • Premature birth (delivery before the 37th week of gestation), low birth weight (birth weight <2500g) for 2-month-old (60-89 days) and 3-month-old (90-119 days) infants
  • History of abnormal labor, asphyxia, and neurological damage
  • Those who have suffered from pertussis, diphtheria or tetanus
  • Individuals who have had household contact with individuals with confirmed pertussis, diphtheria, or tetanus disease in the past 30 days
  • History of allergy to vaccines or vaccine components, severe side effects to vaccines such as allergy, urticaria, respiratory distress, angioneurotic edema
  • Those with a history of epilepsy, convulsions, convulsions, cerebral palsy, or a history of mental illness or family history; or other progressive neurological disorders
  • Have been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune disease
  • Any condition resulting in absence of spleen, defective spleen function
  • Known or suspected acute disease or serious chronic disease (including: serious respiratory disease, serious cardiovascular disease, liver and kidney disease, serious skin disease, malignant tumor, etc.); or in the acute phase of chronic disease
  • Physician-diagnosed coagulation abnormalities (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disorders
  • Have had immunosuppressive or modifying agents, cytotoxic continuous treatment for more than 10 days in the past 6 months (except inhaled and topical steroids)
  • Received blood products (except hepatitis B immunoglobulin) within 3 months prior to receiving the experimental vaccine
  • Received another investigational drug or investigational vaccine within 1 month prior to receiving the experimental vaccine
  • Plan to participate or are participating in any other drug clinical studies
  • Received a live attenuated vaccine within 14 days prior to receiving the experimental vaccine, or received another vaccine within 7 days
  • Those with fever before vaccination, axillary body temperature >37.0°C
  • Any other factors that, in the judgment of the investigator, make participation in the clinical trial inappropriate
  • 1-20 articles for the first dose exclusion criteria
  • Those who had a severe allergic reaction after the previous dose of vaccine
  • Persons with serious adverse reactions causally related to the previous dose of vaccination
  • Newly discovered or newly occurred after the first vaccination that do not meet the first dose inclusion criteria or meet the first dose exclusion criteria will be determined by the investigator whether to continue to participate in the study
  • Other reasons for exclusion as perceived by the researcher
  • 22-25 for the 2nd, 3rd, 4th agent exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental vaccine group A，3 months old
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Active Comparator: Control vaccine group B，3 months old
4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
Biological: Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Active Comparator: Control vaccine group C，3 months old
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
Biological: Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Experimental: Experimental vaccine group D，2 months old
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22
Biological: DTcP
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Biological: DTcP
Three doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Active Comparator: Control vaccine group E，2 months old
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22
Biological: DTaP-IPV-Hib
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Experimental: Experimental vaccine group F，2 months old
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22
Biological: DTcP
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Biological: DTcP
Three doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group
Time Frame: 30 days after completion of basal immunization
30 days after completion of basal immunization
Serum anti-PT, FHA, PRN, DT, TT antibody positive conversion rate, Geometric Mean Concentration(GMC) 30 days after completion of basal immunization in subjects in the 2-month-old group
Time Frame: 30 days after completion of basal immunization
30 days after completion of basal immunization
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group
Time Frame: Within 0-30 days after each dose of vaccination
Within 0-30 days after each dose of vaccination
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group
Time Frame: Within 0-30 days after each dose of vaccination
Within 0-30 days after each dose of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CanSino Biologics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

July 2, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-CTP-DTcP-Ⅲ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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