Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants (NCT06344065) | Clinical Trial Compass
RecruitingPhase 3
Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
China1,584 participantsStarted 2023-12-21
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
Who can participate
Age range
3 Months – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. 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;
Exclusion criteria
. Has a history of pertussis, diphtheria, or tetanus;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immunogenicity results of experimental group and active control group (DTaP)
Timeframe: 30 days after basic immunization
2
Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T)
. 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 disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc;
. 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;