Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children ( DTaP/DT )
DTaP/DT
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
1 other identifier
interventional
480
1 country
2
Brief Summary
This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedMay 23, 2023
May 1, 2023
7 months
May 12, 2023
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Safety of the DTaP or DT vaccine immunization
28 days after the vaccination
Geometric mean antibody concentrations before the vaccination
before the dose of DTaP or DT
Geometric mean antibody concentrations after the vaccination
28-42 days after the dose of DTaP or DT
Study Arms (2)
Group A
EXPERIMENTALGroup with DTap vaccination produced by Chendu Institute of Biological Products Co., Ltd
Group B
EXPERIMENTALGroup with DT vaccination
Interventions
Eligibility Criteria
You may qualify if:
- \. 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℃.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fuyang Center for Disease Control and Prevention
Hangzhou, Zhejiang, 311400, China
Tongxiang Center for Disease Control and Prevention
Jiaxing, Zhejiang, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
May 23, 2023
Study Start
May 1, 2023
Primary Completion
December 1, 2023
Study Completion
November 1, 2024
Last Updated
May 23, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share