New booster vaccine trial aims to shield japanese teens from three serious diseases
NCT ID NCT07596173
First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 8 times
Summary
This study tests a single booster dose of a combined vaccine against diphtheria, tetanus, and whooping cough (dTpa) in 85 healthy Japanese adolescents aged 11 to 13. Researchers will check if the shot triggers a strong immune response and monitor for side effects one month after vaccination. The goal is to see if this booster can keep teens protected against these infections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dTpa vaccine (combined reduced-antigen diphtheria, tetanus, and acellular pertussis vaccine)
- What this could lead to
- If successful, this could confirm that a single booster dose of this dTpa vaccine effectively protects Japanese adolescents against diphtheria, tetanus, and pertussis.
- What could go wrong
- This is a small, single-arm study with no comparison group, so results may not apply broadly. The vaccine may cause mild side effects like soreness or fever, and long-term protection is not measured here.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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90 people
The number who actually took part.
- Started
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Jun 2026
- Finished
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Sep 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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11 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 pregnancy test within 24 hours prior to the study intervention administration, and * has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series. Exclusion Criteria: Medical conditions * History of physician-diagnosed or laboratory-confirmed diphtheria, tetanus or pertussis diseases within the past 5 years. * History of encephalopathy after administration of a previous dose of pertussis vaccine that could not be attributed to another identifiable cause, progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. * History of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * Acute or unstable chronic conditions clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. * Condition that in the judgment of the investigator would make intramuscular injection unsafe. Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the study period. * Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period. * Chronic administration of immune-modifying drugs and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * Up to 6 months prior to the study intervention administration: For corticosteroids, this will mean prednisone equivalent ³0.5 mg/kg/day with maximum of 20 mg/day. Inhaled, intra-articular/intra-bursal and topical steroids are allowed. * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy, monoclonal antibodies, antitumoral medication. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 30 days after the dose of study intervention(s) administration\*, with the exception of inactivated influenza vaccine and SARS-CoV-2 vaccine which can be given at any time during the study conduct. \*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and Sponsor is notified. * Planned administration of any prophylactic medication in the absence of any symptom and in anticipation of a reaction to the study intervention administration. Prior/Concurrent clinical study participation • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention vaccine/drug/invasive medical device. Other exclusion criteria * Pregnant or lactating participant. * History of /current chronic alcohol consumption and/or drug abuse, based on investigator's judgment. * Any study personnel or their immediate dependents, family, or household members. * Child in care.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GSK Investigational Site
Fukuoka, 812-0871, Japan
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GSK Investigational Site
Hokkaido, 004-0052, Japan
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GSK Investigational Site
Hokkaido, 006-0814, Japan
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GSK Investigational Site
Hokkaido, 062-0907, Japan
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GSK Investigational Site
Kumamoto, 862-0924, Japan
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GSK Investigational Site
Mie, 511-0865, Japan
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GSK Investigational Site
Osaka, 554-0014, Japan
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GSK Investigational Site
Saitama, 337-0042, Japan
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GSK Investigational Site
Saitama, 360-0812, Japan
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GSK Investigational Site
Shizuoka, 420-8623, Japan
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Other studies related to the condition(s) this trial covers.