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Tests treatment safety and results for Healthy Volunteers
Official title Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
ClinicalTrials.gov ID: NCT06344065
What this study is testing
What is Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed)?
Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for healthy volunteers.
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 this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
- Phase 3: a large, late-stage 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 3 to 3. Healthy volunteers may be eligible.
You may be able to join if
- Basic immune stage:
- 3-month-old infants who can provide valid identification documents;
- Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g);
- The legal guardian of the subject voluntarily agrees to their child's participation in the trial and signs a written informed consent form;
- The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits;
You likely can't join if
- Basic immune stage:
- Has a history of pertussis, diphtheria, or tetanus;
- Has any history of severe allergies to vaccination in the past;
- Allergy to any component of the experimental vaccine;
- Has a history or family history of epilepsy, convulsions, encephalopathy, mental illness;
- Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous...
See the full eligibility criteria
- Basic immune stage:
- 3-month-old infants who can provide valid identification documents;
- Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g);
- The legal guardian of the subject voluntarily agrees to their child's participation in the trial and signs a written informed consent form;
- The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits;
- Has not received a vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine;
- Active control group 2 has not been vaccinated with any vaccine containing the active ingredients of poliomyelitis vaccine or haemophilus influenzae vaccine;
- Enhanced immunity stage:
- Infants and young children aged 18-24 months who have been enrolled in this clinical trial at the age of 3 months;
- Basic immunization has been completed in this clinical trial;
- According to the researcher's opinion, the people and their legal guardians are able to comply with the requirements of the clinical trial protocol.
- Basic immune stage:
- Has a history of pertussis, diphtheria, or tetanus;
- Has any history of severe allergies to vaccination in the past;
- Allergy to any component of the experimental vaccine;
- Has a history or family history of epilepsy, convulsions, encephalopathy, mental illness;
- Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
- Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the trial including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart...
- Has the history of severe abnormal production process, suffocation rescue, neurological damage, and current pathological jaundice;
- Suffering from infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, or HIV infection confirmed by parents;
- Within 3 months before to enrollment, has received systemic corticosteroid treatment (any route of administration, ≥ 2mg/kg/day) for ≥ 14 days, such as prednisone, inhaled steroids such as budesonide, and fluticasone...
- Within 3 months before enrollment，has received treatment with immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) ;
- Participating in or planning to participate in clinical trials of other drugs in the near future;
- According to the researcher's judgment, there are any other factors that are not suitable for the people to participate in the clinical trial.
- Enhanced immunity stage:
- Newly discovered severe allergic history to any previous vaccination;
- Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
- Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the test, including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart...
- After completing basic immunization, people were vaccinated with other vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine before booster immunization;
- Participating in or planning to participate in clinical trials of other drugs in the near future;
- According to the researcher's judgment, there are any other factors that are not suitable for the people to participate in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, Guangxi, 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, 3 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 Nanning, Guangxi, 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.