Clinical trial NCT04099303: Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: Infection
DTcP
Whooping Cough
Vaccine
Diphtheria
Tetanus
Pertussis
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2019-09-23
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety items of adverse reactions
timeFrame: within 30 minutes post-vaccination
measure: Safety items of adverse reactions
timeFrame: within 7 days post-vaccination
measure: Safety items of SAE: Occurrence of SAE
timeFrame: within 360 days post-vaccination
measure: Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures
timeFrame: the fourth day post-vaccination
measure: Safety items of adverse reactions
timeFrame: within 8-30 days post-vaccination
measure: Safety items of adverse reactions
timeFrame: within 30 days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Xuchang
country: China
facility: Changge Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Province Center for Disease Control and Prevention
name: Wang Yanxia
role: PRINCIPAL_INVESTIGATOR
References: