Status:
COMPLETED
Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
Lead Sponsor:
CanSino Biologics Inc.
Collaborating Sponsors:
Henan Center for Disease Control and Prevention
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
2-6 years
Phase:
PHASE1
Brief Summary
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. ...
Detailed 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 month...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04099303
Start Date
April 28 2020
End Date
November 25 2021
Last Update
October 31 2022
Active Locations (1)
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1
Changge Center for Disease Control and Prevention
Xuchang, Henan, China, 461500