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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05870631
Other study ID # DTaP/DT-2023-02
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date May 2023
Est. completion date November 2024

Study information

Verified date May 2023
Source Zhejiang Provincial Center for Disease Control and Prevention
Contact Hanqing He
Phone +86 571 87115170
Email hanqinghe@cdc.zj.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 480
Est. completion date November 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 72 Months to 84 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
vaccinate with DTaP
vaccinate with DTaP
vaccinate with DT
vaccinate with DT

Locations

Country Name City State
China Fuyang Center for Disease Control and Prevention Hangzhou Zhejiang
China Tongxiang Center for Disease Control and Prevention Jiaxing Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Zhejiang Provincial Center for Disease Control and Prevention China National Biotec Group Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroconversion rates of the vaccination 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 28-42 days after the dose of DTaP or DT
Primary Seropositive rates after the vaccination The percentage of participants with positive antibody against pertussis,diphtheria and tetanus. 28-42 days after the dose of DTaP or DT
Secondary Safety of the DTaP or DT vaccine immunization The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT 28 days after the vaccination
Secondary Geometric mean antibody concentrations before the vaccination The GMC against pertussis,diphtheria and tetanus before the dose of DTaP or DT
Secondary Geometric mean antibody concentrations after the vaccination The GMC against pertussis,diphtheria and tetanus 28-42 days after the dose of DTaP or DT
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