Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children (DTaP/DT)

Zhejiang Provincial Center for Disease Control and Prevention

Status and phase: Not yet enrolling; Phase 4

Conditions: Vaccine Reaction

Treatments: Biological: vaccinate with DTap; Biological: vaccinate with DT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05870618

DTaP/DT-2023-01

Details and patient eligibility

About

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

Full 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 Wuhan 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 72 to 84 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Group A

Experimental group

Description:

Group with DTap vaccination produced by Wuhan Institute of Biological Products Co., Ltd

Treatment:

Biological: vaccinate with DTap

Group B

Experimental group

Description:

Group with DT vaccination

Treatment:

Biological: vaccinate with DT