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

Primary Purpose

Diphtheria, Tetanus and Acellular Pertussis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine,DTaP
Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed)and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib
DTcP
DTaP-IPV-Hib
DTcP
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria, Tetanus and Acellular Pertussis focused on measuring Vaccine, Three Components, Immunogenicity, Safety

Eligibility Criteria

2 Months - 3 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Changge Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Experimental vaccine group A,3 months old

Control vaccine group B,3 months old

Control vaccine group C,3 months old

Experimental vaccine group D,2 months old

Control vaccine group E,2 months old

Experimental vaccine group F,2 months old

Arm Description

4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21

4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21

4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21

4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22

4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22

4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22

Outcomes

Primary Outcome Measures

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
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
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group

Secondary Outcome Measures

Full Information

First Posted
July 2, 2023
Last Updated
August 12, 2023
Sponsor
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05951725
Brief Title
A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus and Acellular Pertussis
Keywords
Vaccine, Three Components, Immunogenicity, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental vaccine group A,3 months old
Arm Type
Experimental
Arm Description
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
Arm Title
Control vaccine group B,3 months old
Arm Type
Active Comparator
Arm Description
4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
Arm Title
Control vaccine group C,3 months old
Arm Type
Active Comparator
Arm Description
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21
Arm Title
Experimental vaccine group D,2 months old
Arm Type
Experimental
Arm Description
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22
Arm Title
Control vaccine group E,2 months old
Arm Type
Active Comparator
Arm Description
4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22
Arm Title
Experimental vaccine group F,2 months old
Arm Type
Experimental
Arm Description
4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22
Intervention Type
Biological
Intervention Name(s)
Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine,DTaP
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed)and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
DTcP
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-Hib
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
DTcP
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Wan
Phone
022-58213600-6051
Email
peng.wan@cansinotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanxia Wang
Email
wangyanxia99@163.com
Facility Information:
Facility Name
Changge Center for Disease Control and Prevention
City
Xuchang
State/Province
Henan
ZIP/Postal Code
461500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Lili
Phone
13643826177
Email
13643826177@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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