Vaccine Reaction
Conditions
Keywords
immunogenicity，safety，DTap，DT
Brief summary
This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.
Detailed description
A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Chengdu Institute of Biological Products Co., Ltd. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\ 42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.
Interventions
BIOLOGICALvaccinate with DTaP
vaccinate with DTaP
BIOLOGICALvaccinate with DT
vaccinate with DT
Sponsors
China National Biotec Group Company Limited
Zhejiang Provincial Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
72 Months to 84 Months
Healthy volunteers
Yes
Inclusion criteria
* 1\. Participants aged ≥ 6 on the day of enrollment; 2. Informed consent should be signed and dated by the participants; 3. The participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures; 4. The participants have received 4 doses of acellular TDap vaccine and have not received any immunization agents related to diphtheria, tetanus, and pertussis in the past 3 years; 5. The participant has no diease history of pertussis, diphtheria or tetanus; 6. ≥ 14 days interval between the last vaccination; 7. Body temperature was ≤37.3℃.
Exclusion criteria
* 1、Being allergic to any component of vaccines ； 2、A history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）； 3、Having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases; 4、Participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to HIV, or having congenital immune disorders in close family members; 5、Injection of non-specific immunoglobulin within 1 month before enrollment; 6、Participants are suffering from acute febrile diseases and infectious diseases; 7、A history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection; 8、Participants with severe chronic diseases or acute episodes of chronic diseases; 9、Participants with infectious, suppurative and allergic skin diseases; 10、Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rates of the vaccination | 28-42 days after the dose of DTaP or DT | Defined as any positive antibody response against pertussis，diphtheria，tetanus in children who were seronegative prior to the vaccination, or at least a fourfold increase in antibody levels against pertussis for children who had pre-existing positive antibodies |
| Seropositive rates after the vaccination | 28-42 days after the dose of DTaP or DT | The percentage of participants with positive antibody against pertussis，diphtheria and tetanus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the DTaP or DT vaccine immunization | 28 days after the vaccination | The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT |
| Geometric mean antibody concentrations before the vaccination | before the dose of DTaP or DT | The GMC against pertussis，diphtheria and tetanus |
| Geometric mean antibody concentrations after the vaccination | 28-42 days after the dose of DTaP or DT | The GMC against pertussis，diphtheria and tetanus |
Countries
China
Contacts
Primary ContactHanqing He
Backup ContactXuewen Tang
Outcome results
None listed