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

Sponsor

CanSino Biologics Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05951725

Collaborator

(none)

2,520

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diphtheria, Tetanus and Acellular Pertussis	Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP) Biological: Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP Biological: Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib Biological: DTcP Biological: DTaP-IPV-Hib Biological: DTcP	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2520 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.
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, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.

Outcome Measures

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 [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 [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 [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 [Within 0-30 days after each dose of vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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