UnknownPhase 4

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

China480 participantsStarted 2023-05

Plain-language summary

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

Who can participate

Age range

72 Months – 84 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants aged ≥ 6 on the day of enrollment;
. Informed consent should be signed and dated by the participants;
. The participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures;
. 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;
. The participant has no diease history of pertussis, diphtheria or tetanus;
. ≥ 14 days interval between the last vaccination;
. Body temperature was ≤37.3℃.

Exclusion criteria

. Being allergic to any component of vaccines ；
. A history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）；
. Having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Seroconversion rates of the vaccination

Timeframe: 28-42 days after the dose of DTaP or DT

Seropositive rates after the vaccination

Timeframe: 28-42 days after the dose of DTaP or DT

Trial details

NCT IDNCT05870618

SponsorZhejiang Provincial Center for Disease Control and Prevention

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Hanqing He

+86 571 87115170 hanqinghe@cdc.zj.cn

View on ClinicalTrials.gov More Vaccine Reaction trials