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Tests treatment safety and results for Diphtheria-Tetanus-acellular Pertussis Vaccines
Official title 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
ClinicalTrials.gov ID: NCT07596173
What this study is testing
What is dTpa vaccine?
dTpa vaccine is an investigational medicine, being studied as a potential treatment for diphtheria-tetanus-acellular pertussis vaccines.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 12. Healthy volunteers may be eligible.
You may be able to join if
- Participants and/or participants' parent(s)/ Legally acceptable representative(s) [LAR(s)], who, in the opinion of the investigator, can and will...
- 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).
You likely can't join if
- 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...
- 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...
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
- Hokkaido, Japan
- Kumamoto, Japan
- Mie, Japan
- Osaka, Japan
- Saitama, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan; Hokkaido, Japan; Kumamoto, Japan; Mie, Japan; Osaka, Japan; Saitama, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.