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

Tetanus Clinical Trial

— PCTDTcP  

Official title:

A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099303
• Other study ID #: CS-CTP-DTcP-?
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2020
• Est. completion date: November 25, 2021

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 25, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Changge Center for Disease Control and Prevention	Xuchang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Henan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety items of adverse reactions	Occurrence of adverse reactions	within 30 minutes post-vaccination
Primary	Safety items of adverse reactions	Occurrence of adverse reactions	within 7 days post-vaccination
Primary	Safety items of SAE: Occurrence of SAE	Occurrence of SAE	within 360 days post-vaccination
Primary	Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures	Occurrence of abnormal changes of laboratory measures	the fourth day post-vaccination
Primary	Safety items of adverse reactions	Occurrence of adverse reactions	within 8-30 days post-vaccination
Primary	Safety items of adverse reactions	Occurrence of adverse reactions	within 30 days post-vaccination