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

Phase 4

Not yet recruiting

• Conditions: Vaccine Reaction
• Interventions: Biological: vaccinate with DTap; Biological: vaccinate with DT

• Registration Number: NCT05870618
• Lead Sponsor: Zhejiang Provincial Center for Disease Control and Prevention

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 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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Primary Completion: 2023-12
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	vaccinate with DTap	Group with DTap vaccination produced by Wuhan Institute of Biological Products Co., Ltd
Group B	vaccinate with DT	Group with DT vaccination

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Geometric mean antibody concentrations after the vaccination	28-42 days after the dose of DTaP or DT	The GMC against pertussis，diphtheria and tetanus
Geometric mean antibody concentrations before the vaccination	before the dose of DTaP or DT	The GMC against pertussis，diphtheria and tetanus
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

Trial Locations

Locations (2)

Yiwu Center for Disease Control and Prevention; 🇨🇳 Jinhua, Zhejiang, China

longyou Center for Disease Control and Prevention; 🇨🇳 Quzhou, Zhejiang, China