Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
NCT ID: NCT04099303
Last Updated: 2022-10-31
Study Results
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Basic Information
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COMPLETED
PHASE1
400 participants
INTERVENTIONAL
2020-04-28
2021-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vaccine 1A
Subjects received one dose of DTaP aged 4 to 6 years.
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Vaccine 1B
Subjects received one dose of DT aged 4 to 6 years.
Diphtheria and Tetanus Combined Vaccine, Adsorbed
2mL, Intramuscular Other Name: DT
Vaccine 2A
Subjects received one dose of DTcP aged 18 to 24 months.
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Vaccine 2B
Subjects received one dose of DTaP aged 18 to 24 months.
Diphtheria-tetanus-acellular pertussis vaccine
0.5 mL, Intramuscular Other Name: DTaP
Vaccine 3A
Subjects received three doses of DTcP at 3,4,5 months of age.
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Vaccine 3B
Subjects received three doses of DTaP at 3,4,5 months of age.
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Diphtheria-tetanus-acellular pertussis vaccine
0.5 mL, Intramuscular Other Name: DTaP
Vaccine 3C
Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
0.5 mL, Intramuscular Other Name: PENTAXIM
Vaccine 4A
Subjects received three doses of DTcP at 2,3,4 months of age.
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Vaccine 4B
Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
0.5 mL, Intramuscular Other Name: PENTAXIM
Vaccine 4C
Subjects received three doses of DTcP at 2,4,6 months of age.
Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Interventions
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Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
0.5 mL, Intramuscular Other Name: DTcP
Diphtheria and Tetanus Combined Vaccine, Adsorbed
2mL, Intramuscular Other Name: DT
Diphtheria-tetanus-acellular pertussis vaccine
0.5 mL, Intramuscular Other Name: DTaP
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
0.5 mL, Intramuscular Other Name: PENTAXIM
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Months
6 Years
ALL
Yes
Sponsors
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Henan Center for Disease Control and Prevention
OTHER_GOV
CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wang Yanxia
Role: PRINCIPAL_INVESTIGATOR
Henan Province Center for Disease Control and Prevention
Locations
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Changge Center for Disease Control and Prevention
Xuchang, Henan, China
Countries
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Other Identifiers
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CS-CTP-DTcP-Ⅰ
Identifier Type: -
Identifier Source: org_study_id
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