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New treatment option for Prevent Whooping Cough
Official title Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial
ClinicalTrials.gov ID: NCT07112144
What this study is testing
What is DTacP?
DTacP is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prevent whooping cough.
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 immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.
- 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 2 to 3. Healthy volunteers may be eligible.
You may be able to join if
- Healthy infants and young children who are permanent residents aged 2 months (60-89 days), and can provide valid identification documents for the...
- Obtain the informed consent of the subject's legal guardian and sign the informed consent form;
- The legal guardian of the subject can comply with the requirements of the clinical trial protocol.
You likely can't join if
- History of pertussis, diphtheria, or tetanus;
- Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days;
- Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib...
- Premature infants (born before 37 weeks of gestation), infants with severe abnormal labor processes or a history of asphyxia rescue, or low birth...
- Axillary temperature \>37.0°C on the day of enrollment\ ;
- Severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, or congenital diseases (such as Down syndrome...
See the full eligibility criteria
- Healthy infants and young children who are permanent residents aged 2 months (60-89 days), and can provide valid identification documents for the subject and their legal guardian;
- Obtain the informed consent of the subject's legal guardian and sign the informed consent form;
- The legal guardian of the subject can comply with the requirements of the clinical trial protocol.
- History of pertussis, diphtheria, or tetanus;
- Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days;
- Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine;
- Premature infants (born before 37 weeks of gestation), infants with severe abnormal labor processes or a history of asphyxia rescue, or low birth weight infants (\<2500g);
- Axillary temperature \>37.0°C on the day of enrollment\ ;
- Severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, or congenital diseases (such as Down syndrome, sickle cell anemia, congenital nervous system diseases, etc.);
- History of epilepsy, convulsions, or seizures, history of cerebral palsy, or family history of mental illness;
- Autoimmune diseases or immunodeficiencies (such as perianal abscesses suggesting possible immunodeficiency in infants, human immunodeficiency virus infection, lymphoma, leukemia, etc.), or parents/siblings with...
- Asplenia or splenic dysfunction due to any cause;
- Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation diseases, platelet abnormalities) or obvious bruising/coagulation disorders that may contraindicate intramuscular...
- History of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reactions), history of severe allergic reactions to any...
- Vaccination with subunit or inactivated vaccines within the past 7 days; vaccination with live attenuated vaccines within the past 14 days\ ;
- Receipt of immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) before enrollment;
- Receipt of any immunostimulant or immunosuppressant therapy before enrollment (continuous oral administration or infusion for ≥14 days, or topical steroid use [inhaled, nasal spray, intra-articular, eye drops...
- Suffering from acute illnesses within 3 days before enrollment (acute illness is defined as moderate or severe illness with or without fever)\ ;
- Administration of prophylactic medications (such as antipyretic analgesics, antiallergic drugs, antidiarrheal drugs, etc.) within 3 days before enrollment\ ;
- Known or suspected severe clinically diagnosed diseases (including but not limited to severe diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory...
- Currently participating in other clinical trials or planning to participate in other trials during the study period;
- Any other factors that, in the judgment of the researcher, make the subject unsuitable for participating in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, 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 3 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, 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.