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

• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05870618
• Collaborator: China National Biotec Group Company Limited (Industry)
• Enrollment: 480
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 18.1
• Patients Per Site: 240
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vaccine Reaction	Biological: vaccinate with DTap; Biological: vaccinate with DT	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Group with DTap vaccination produced by Wuhan Institute of Biological Products Co., Ltd	Biological: vaccinate with DTap; vaccinate with DTap
Experimental: Group B Group with DT vaccination	Biological: vaccinate with DT; vaccinate with DT

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. Geometric mean antibody concentrations before the vaccination [before the dose of DTaP or DT]

   The GMC against pertussis，diphtheria and tetanus

3. Geometric mean antibody concentrations after the vaccination [28-42 days after the dose of DTaP or DT]

   The GMC against pertussis，diphtheria and tetanus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 72 Months to 84 Months
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yiwu Center for Disease Control and Prevention	Jinhua	Zhejiang	China	322000
2	longyou Center for Disease Control and Prevention	Quzhou	Zhejiang	China	324400

Sponsors and Collaborators

• Zhejiang Provincial Center for Disease Control and Prevention
• China National Biotec Group Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhejiang Provincial Center for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT05870618
• Other Study ID Numbers: DTaP/DT-2023-01
• First Posted: May 23, 2023
• Last Update Posted: May 23, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhejiang Provincial Center for Disease Control and Prevention: immunogenicity，safety，DTaP，DT

Study Results

No Results Posted as of May 23, 2023