A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and A… (NCT07596173) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Healthy Japanese Adolescents Aged 11 Years to <13 Years
85 participantsStarted 2026-06-29
Plain-language summary
The purpose of the study is to assess the immune response, reactogenicity and safety of a booster dose of dTpa vaccine 1 month after vaccination in healthy Japanese participants aged 11 to \<13 years.
Who can participate
Age range
11 Years – 12 Years
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 and/or participants' parent(s)/ Legally acceptable representative(s) \[LAR(s)\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Physical or digital informed assent obtained from the participant prior to performance of any study-specific procedure.
* Physical or digital informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
* Healthy participants as established by medical history and clinical examination at screening.
* Male/female participant between and including 11 and \<13 years of age at the time of the study intervention administration (Visit 1/Day 1).
* Previously completed all routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s). Participants with documented previous diphtheria, tetanus and pertussis vaccination (primary series and first booster) as per routine vaccination in Japan prior to study enrolment.
* Participants did not receive an additional diphtheria, tetanus with or without pertussis vaccination within 5 years prior to enrolment in the study.
* Japanese ethnic origin.
* Participants of non-childbearing potential may be enrolled in the clinical study.
* Participant of childbearing potential may be enrolled in the study if the participant:
* has practiced adequate contraception for at least 30 days prior to study intervention administration, and
* has a negative …
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
1
Number of seropositive participants for anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Timeframe: 1 month after vaccination
2
Number of seroprotected participants for anti-diphteria and anti-tetanus antibodies