Vaccine ReactionPhase 4DTaP/DTNCT05870631
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children ( DTaP/DT )
A Phase 4 study testing vaccinate with DTaP and vaccinate with DT in people with Vaccine Reaction, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.
Trial summary
This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years. Read more about this study
- Who is it for?
- Ages 72 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- vaccinate with DTaP and vaccinate with DT
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesChina
- Study dates
- May 2023to Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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℃.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fuyang Center for Disease Control and Prevention
Hangzhou, Zhejiang, 311400
Junjie Jin, +86 571 61758176, 2546803342@qq.com
Tongxiang Center for Disease Control and Prevention
Jiaxing, Zhejiang
Jinwei Wu, +86 18858311061, 759716707@qq.com
About this study
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
This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.
Read the 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 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.
- Conditions
- Vaccine Reaction
- Being tested
- vaccinate with DTaP, vaccinate with DT
- Keywords
- immunogenicity，safety，DTap，DT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccinate with DTaPBiological
vaccinate with DTaP
vaccinate with DTBiological
vaccinate with DT
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group with DTap vaccination produced by Chendu Institute of Biological Products Co., Ltd Receives: Biological: vaccinate with DTaP |
| Group B | Experimental | Group with DT vaccination Receives: Biological: vaccinate with DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 28-42 days after the dose of DTaP or DT
Secondary outcomes (3)
Safety of the DTaP or DT vaccine immunization
The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT
Measured: 28 days after the vaccination
Geometric mean antibody concentrations before the vaccination
The GMC against pertussis，diphtheria and tetanus
Measured: before the dose of DTaP or DT
Geometric mean antibody concentrations after the vaccination
The GMC against pertussis，diphtheria and tetanus
Measured: 28-42 days after the dose of DTaP or DT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- China National Biotec Group Company Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870631
- Sponsor's protocol ID
- DTaP/DT-2023-02
- Acronym
- DTaP/DT
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05870631
- Acronym / sponsor ID
- DTaP/DT / DTaP/DT-2023-02
- Conditions
- Vaccine Reaction
- Keywords
- immunogenicity，safety，DTap，DT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Collaborators
- China National Biotec Group Company Limited
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: vaccinate with DTaPGroup with DTap vaccination produced by Chendu Institute of Biological Products Co., Ltd |
| Group B | Experimental | Biological: vaccinate with DTGroup with DT vaccination |
Who may qualify
- Ages
- 72 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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℃.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaccinate with DTaPvaccinate with DTaP | Biological | Group A |
| vaccinate with DTvaccinate with DT | Biological | Group B |
Primary outcome
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
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.
3 secondary outcomes
Safety of the DTaP or DT vaccine immunization
Time frame: 28 days after the vaccination
Geometric mean antibody concentrations before the vaccination
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vaccinate with DTaP and vaccinate with DT in people with Vaccine Reaction, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanqing He (+86 571 87115170, hanqinghe@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rates of the vaccination (time frame: 28-42 days after the dose of DTaP or DT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.