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

Vaccine Reaction Clinical Trial

— DTaP/DT  

Official title:

Immunogenicity and Safety of Adsorbed Diphtheria, Tetanus, Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Children#a Randomized, Controlled Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05870631
• Other study ID #: DTaP/DT-2023-02
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Vaccine Reaction

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