Actively Recruiting
Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
Led by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Updated on 2024-04-03
1584
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
CONDITIONS
Official Title
Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants who are 3 months old with valid identification documents
- Born after 37 to 42 weeks of pregnancy with a birth weight between 2500g and 4500g
- Legal guardian agrees voluntarily and signs informed consent
- Legal guardian is able to understand the trial and attend all follow-up visits
- Has not received any vaccine with pertussis, diphtheria, or tetanus components
- For active control group 2, no prior vaccination with poliomyelitis or haemophilus influenzae vaccines
- For booster stage: infants aged 18-24 months previously enrolled and completed basic immunization in this trial
- Subjects and guardians able to comply with trial protocol as judged by researcher
You will not qualify if you...
- History of pertussis, diphtheria, or tetanus
- History of severe allergic reactions to vaccines
- Allergy to any component of the experimental vaccine
- History or family history of epilepsy, convulsions, encephalopathy, or mental illness
- Thrombocytopenia, coagulation problems, or on anticoagulant therapy contraindicating injections
- Serious congenital malformations or diseases interfering with trial participation (e.g., infant wheezing, Down syndrome, severe thalassemia, heart, liver, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, immune defects)
- History of severe birth complications or current pathological jaundice
- Infectious diseases such as tuberculosis, hepatitis B or C, or HIV
- Recent systemic corticosteroid use or immunosuppressants within 3 months before enrollment
- Recent treatment with immunoglobulin or blood products except hepatitis B immunoglobulin
- Participation in other drug clinical trials
- Any other condition judged unsuitable for trial participation by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China, 530028
Actively Recruiting
Research Team
W
Wenjian Fang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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