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

NCT ID: NCT05951725

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 2520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-11
• Study Completion Date: 2025-04-01

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.

Conditions

Diphtheria, Tetanus and Acellular Pertussis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental vaccine group A，3 months old

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

Group Type: EXPERIMENTAL

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)

Intervention Type: BIOLOGICAL

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.

Control vaccine group B，3 months old

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

Group Type: ACTIVE_COMPARATOR

Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP

Intervention Type: BIOLOGICAL

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.

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

Group Type: ACTIVE_COMPARATOR

Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib

Intervention Type: BIOLOGICAL

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 vaccine group D，2 months old

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

Group Type: EXPERIMENTAL

DTcP

Intervention Type: BIOLOGICAL

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.

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

Group Type: ACTIVE_COMPARATOR

DTaP-IPV-Hib

Intervention Type: BIOLOGICAL

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 vaccine group F，2 months old

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

Group Type: EXPERIMENTAL

DTcP

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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

• Other reasons for exclusion as perceived by the researcher

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
• 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Changge Center for Disease Control and Prevention

Xuchang, Henan, China

Countries

China

Other Identifiers

CS-CTP-DTcP-Ⅲ

Identifier Type: -

Identifier Source: org_study_id