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New treatment option for Diphtheria
Official title Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine
ClinicalTrials.gov ID: NCT06184542
What this study is testing
What is DTacP (one-dose booster)?
DTacP (one-dose booster) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diphtheria.
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
- This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 6. Healthy volunteers may be eligible.
You may be able to join if
- Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment
- Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and...
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification...
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and...
- Birth Outcome Condition: Toddlers (aged 18-24 months) and Infants (aged 2-3 months) should be born at full term (37-42 weeks of gestation) with birth...
You likely can't join if
- people meeting any of the following exclusion criteria will be not eligible for enrollment.
- Previous Diagnosis: people diagnosed with pertussis, tetanus, or diphtheria disease.
- Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): people have been with abnormal labor (dystocia, instrumental...
- Allergic History: people have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected...
- Vaccination History: people received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with...
- Acute Illness: people have acute illness (e.g., fever) or acute exacerbation of a chronic illness within 3 days before receipt of the first dose of...
See the full eligibility criteria
Who can join
- Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment
- Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and Pertussis combined vaccine, and not yet received the Diphtheria...
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed...
- Birth Outcome Condition: Toddlers (aged 18-24 months) and Infants (aged 2-3 months) should be born at full term (37-42 weeks of gestation) with birth weight ≥2500g.
- Temperature Requirement: Axillary body temperature is no more than 37.3°C.
What rules you out
- people meeting any of the following exclusion criteria will be not eligible for enrollment.
- Previous Diagnosis: people diagnosed with pertussis, tetanus, or diphtheria disease.
- Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): people have been with abnormal labor (dystocia, instrumental delivery) or a history of asphyxia, nervous system damage, or clinically...
- Allergic History: people have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected allergy to any vaccine, or other serious adverse reactions, such as...
- Vaccination History: people received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with the investigational vaccine, or any other live attenuated vaccines or...
- Acute Illness: people have acute illness (e.g., fever) or acute exacerbation of a chronic illness within 3 days before receipt of the first dose of the investigational vaccine
- Neurological and Mental Health: people have a history or family history of seizures, epilepsy, and other encephalopathy and psychiatric disorders.
- Health Condition: people have a major congenital malformation, developmental disability, or congenital disease (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders), or other clinically diagnosed...
- Blood Disease: people have genetic bleeding tendency or coagulopathy, or a history of bleeding disorders.
- Infectious Disease: people diagnosed with infectious diseases that may interfere with the study, such as tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.
- Special Condition: people who cannot tolerate venipuncture or have a history of needle and blood sickness.
- Organ Removal History: people with surgical removal of the spleen or other vital organs for any reason.
- Blood Condition: people with blood loss (≥400 ml) and receipt of blood or blood products in the 3 months before receipt of the first dose of the investigational vaccine
- Immune Therapy: people received treatment with an immunosuppressive agent, such as long-term systemic glucocorticoid therapy (treatment with systemic glucocorticoids, such as prednisone or a similar agent, for more than...
- Participation in Other Clinical Studies: people use any investigational or unregistered product (drug, biologic product, or device) within 3 months before receipt of the first dose of the investigational vaccine, plan...
- Physical Examination: (a) people with abnormal vital signs with clinical significance; (b) people abnormal blood routine, blood biochemistry, and urine routine test indicators with clinical significance
- Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study. Contraindications of the second and third doses of the...
- Serious Adverse Events: people experienced serious adverse events related to vaccination after the previous dose.
- Vaccination with other vaccines during the study: (a) people received other diphtheria, Tetanus, and acellular pertussis combined vaccines except for the investigational vaccine after the previous dose during the study...
- Ineligibility: people cannot be eligible or meet exclusion criteria after the previous dose of the investigational vaccine, and the qualification should be determined by the investigator.
- Investigator's Discretion: people determined by the investigator as unsuitable for the following study period.
The study team makes the final eligibility decision.
Where it's taking place
- Dazhou, Sichuan, China
- Yibin, Sichuan, China
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, 2 months to 6 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dazhou, Sichuan, China; Yibin, Sichuan, China. 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.