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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2520

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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