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

May 12, 2023 updated by: Zhejiang Provincial Center for Disease Control and Prevention

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China, 322000
        • Yiwu Center for Disease Control and Prevention
        • Contact:
      • Quzhou, Zhejiang, China, 324400
        • longyou Center for Disease Control and Prevention
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rates of the vaccination
Time Frame: 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
28-42 days after the dose of DTaP or DT
Seropositive rates after the vaccination
Time Frame: 28-42 days after the dose of DTaP or DT
The percentage of participants with positive antibody against pertussis，diphtheria and tetanus
28-42 days after the dose of DTaP or DT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the DTaP or DT vaccine immunization
Time Frame: 28 days after the vaccination
The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT
28 days after the vaccination
Geometric mean antibody concentrations before the vaccination
Time Frame: before the dose of DTaP or DT
The GMC against pertussis，diphtheria and tetanus
before the dose of DTaP or DT
Geometric mean antibody concentrations after the vaccination
Time Frame: 28-42 days after the dose of DTaP or DT
The GMC against pertussis，diphtheria and tetanus
28-42 days after the dose of DTaP or DT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Collaborators

China National Biotec Group Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DTaP/DT-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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