Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed . (PCTDTcP)

CanSino Biologics

Status and phase: Completed; Phase 1

Conditions: Diphtheria; Pertussis; Tetanus

Treatments: Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine; Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; Biological: Diphtheria-tetanus-acellular pertussis vaccine; Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04099303

CS-CTP-DTcP-Ⅰ

Details and patient eligibility

About

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.

Full description

Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.

Enrollment: 400 patients

Sex: All

Ages: 2 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects aged 2months、3months、18-24months and 4-6 years old;
• Willing to provide proof of identity;
• Able to understand and sign the informed consent by guardians or trustees;
• Able and willing comply with the requirements of the protocol by guardians or trustees;
• Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
• Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV;
• Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ;
• Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine;

Exclusion criteria

• Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight< 2300g for girls,<2500g for boys);
• History of abnormal labor process or asphyxia rescue ;
• Subjects who has a medical history of diphtheria, pertussis or tetanus;
• In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families;
• Allergic person;
• Any prior administration of blood products in last 3 month;
• Any prior administration of other research medicines in last 1 month;
• Plans to participate in or is participating in any other drug clinical study;
• Any prior administration of attenuated live vaccine in last 14 days;
• Any prior administration of subunit or inactivated vaccines in last 7 days;
• Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting;
• According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 10 patient groups

Vaccine 1A

Experimental group

Description:

Subjects received one dose of DTaP aged 4 to 6 years.

Treatment:

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

Vaccine 1B

Active Comparator group

Description:

Subjects received one dose of DT aged 4 to 6 years.

Treatment:

Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed

Vaccine 2A

Experimental group

Description:

Subjects received one dose of DTcP aged 18 to 24 months.

Treatment:

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

Vaccine 2B

Active Comparator group

Description:

Subjects received one dose of DTaP aged 18 to 24 months.

Treatment:

Biological: Diphtheria-tetanus-acellular pertussis vaccine

Vaccine 3A

Experimental group

Description:

Subjects received three doses of DTcP at 3,4,5 months of age.

Treatment:

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

Vaccine 3B

Active Comparator group

Description:

Subjects received three doses of DTaP at 3,4,5 months of age.

Treatment:

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

Biological: Diphtheria-tetanus-acellular pertussis vaccine

Vaccine 3C

Active Comparator group

Description:

Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.

Treatment:

Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

Vaccine 4A

Experimental group

Description:

Subjects received three doses of DTcP at 2,3,4 months of age.

Treatment:

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

Vaccine 4B

Active Comparator group

Description:

Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.

Treatment:

Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

Vaccine 4C

Experimental group

Description:

Subjects received three doses of DTcP at 2,4,6 months of age.

Treatment:

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