Safety、Immunogenicity
Conditions
Brief summary
A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine.Main purpose: To evaluate the safety of the adsorbed cell-free whitening break (three components) combination vaccine;Secondary purpose: To preliminarily evaluate the immunogenicity of the adsorbed cell-free whitening break (three components) combination vaccine.
Detailed description
Main endpoint: 1. Adverse events within 30 minutes after vaccination of each test dose; 2. occurrence of solicitation adverse events within 0-7 days after vaccination of each dose; 3. The occurrence of non-solicitation adverse events within 0-30 days after vaccination for each test dose; 4. occurrence of serious adverse events 6 months after the first dose of immunization to the whole immunization. Secondary endpoint: 1. Abnormal occurrence of laboratory test indicators on day 4 after immunization between 4 and 6 years old age groups; 2. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with the cell-free whitening break (three components) for 30 days after the full basal immunization in the 3-month age group; 3. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with cell-free leucocyte (three-component) adsorption at 30 days after 18 to 24 months of age immunization.
Interventions
BIOLOGICALA single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine
A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine
Sponsors
Changchun BCHT Biotechnology Co.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
1. Permanent and healthy people aged 4-6 years old, 18-24 years old, and March age group (90-119 days); 2. Children between the ages of 4 and 6 who complete the whole immunization (4 doses) and do not receive diphtheria tetanus combination vaccine according to diphtheria and immunization program procedures; 3. Children of age groups from 18 to 24 who complete the basic immunization (3 doses) and do not strengthen the immunization according to the immunization planning program; 4. Infants of the age of March who were not vaccinated with one hundred whitening components, 13-valent pneumonia polysaccharide-binding vaccine and Hib vaccine; 5. Obtain the informed consent from the subject's legal guardian, and sign the informed consent form; 6. The legal guardian of the subject can comply with the requirements of the clinical trial protocol; 7. The axillary body temperature of the subject was 37.0℃.
Exclusion criteria
1. Ablaboratory examination indicators for children aged 4 to 6, except minor abnormalities judged by doctors without clinical significance; 2. A history of pertussis, diphtheria, and tetanus; 3. Infants born with preterm birth (birth before the 37th week of gestation), abnormal labor period (dystocia, instrumental midwifery, etc.), low weight (\<2500g male and \<2300g female); only at 3 months of age; 4. Innate malformations or developmental disorders, genetic defects, serious malnutrition, etc.; 5. Patients with epilepsy, convulsions or convulsions, or a family history of psychosis; 6. Autoimmune diseases or immune defects, or parents or siblings have autoimmune diseases or immune defects; 7. No splenic function and defective spleen function caused by any condition; 8. Abnormal coagulation function (such as lack of coagulation factors, abnormal coagulation disease, platelet), or obvious hematoma or coagulation disorder; 9. allergic to a known component of the study vaccine or any previous history of severe allergy (extensive urticaria, angioedema, etc.); 10. Immunoglobulin and / or any blood products (except hepatitis B immunoglobulin) were given within 3 months before the enrollment; 11. Those treated with any immunoenhancement or inhibitor within 3 months (continuous oral or infusion for more than 14 days; 12. Received subunit or inactivated vaccine in the past 7 days, and received live attenuated vaccine in the past 14 days; 13. Acute attacks of various acute diseases or chronic diseases in the past 7 days; 14. According to the investigator, the subject had any other factors not suitable to participate in the clinical trial. The 2 and 3rd vaccination exclusion / delay criteria:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of the adsorbed cell-free whitening break (three-component) combination vaccine was evaluated | Ten months | 1. Adverse events within 30 minutes after vaccination of each test dose; 2. occurrence of solicitation adverse events within 0-7 days after vaccination of each dose; 3. The occurrence of non-solicitation adverse events within 0-30 days after vaccination for each test dose; 4. occurrence of serious adverse events 6 months after the first dose of immunization to the whole immunization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunimmunogenicity of the cell-free (three-component) combination vaccine was evaluated | Ten months | 1. Abnormal occurrence of laboratory test indicators on day 4 after immunization between 4 and 6 years old age groups; 2. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with the cell-free whitening break (three components) for 30 days after the full basal immunization in the 3-month age group; 3. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of the cell-free leucocyte (three components) at 30 days after 18 to 24 months of age immunization. |
Countries
China
Contacts
Primary ContactXiaoping Zhu
Outcome results
None listed