Actively Recruiting
Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine
Led by Institute of Medical Biology, Chinese Academy of Medical Sciences · Updated on 2024-01-03
460
Participants Needed
3
Research Sites
149 weeks
Total Duration
On this page
Sponsors
I
Institute of Medical Biology, Chinese Academy of Medical Sciences
Lead Sponsor
S
Sichuan Center for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.
CONDITIONS
Official Title
Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at enrollment
- Children aged 6 years must have received four doses of Diphtheria, Tetanus, and Pertussis vaccine and not yet received Diphtheria, Tetanus vaccine
- Toddlers aged 18-24 months must have received three doses of Diphtheria, Tetanus, Pertussis vaccine and three doses of Polio vaccine, and not yet received booster doses of these vaccines
- Infants aged 3 months must not have received diphtheria-tetanus-pertussis, polio, 13-valent pneumococcal, Haemophilus influenzae type b, or meningococcal group A and C vaccines
- Infants aged 2 months must not have received diphtheria-tetanus-pertussis, polio, 13-valent pneumococcal, or Haemophilus influenzae type b vaccines
- Volunteers and legal guardians must provide valid legal identification
- Legal guardians must understand the consent, agree to participate, sign consent form, and comply with study visits
- Toddlers and infants must be born full term (37-42 weeks) with birth weight 2500g or more
- Axillary body temperature must be 37.3°C or lower
You will not qualify if you...
- Diagnosis of pertussis, tetanus, or diphtheria disease
- Toddlers and infants with abnormal labor, history of asphyxia, nervous system damage, or pathological jaundice
- History of allergies to vaccine components or serious allergic reactions to vaccines
- Vaccination with inactivated or subunit vaccines within 7 days or live/COVID-19 vaccines within 14 days before study vaccine
- Acute illness or worsening chronic illness within 3 days before first vaccine dose
- History or family history of seizures, epilepsy, encephalopathy, or psychiatric disorders
- Major congenital malformations, developmental disabilities, congenital diseases, or serious chronic diseases
- Genetic bleeding disorders or bleeding history
- Infectious diseases interfering with study (e.g., tuberculosis, hepatitis, HIV)
- History of needle or blood sickness or inability to tolerate venipuncture
- Surgical removal of spleen or vital organs
- Blood loss of 400 ml or more or blood transfusion within 3 months before first dose
- Treatment with systemic immunosuppressive agents within 6 months before first dose
- Participation in other clinical trials or use of investigational products within 3 months before first dose
- Abnormal vital signs or laboratory test results with clinical significance
- Investigator discretion deeming subject unsuitable
- Contraindications for second or third doses include serious adverse events after prior dose, vaccination with other vaccines during study, ineligibility or exclusion after prior dose, or investigator's discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Dazhu Center for Disease Prevention and Control
Dazhou, Sichuan, China
Actively Recruiting
2
Cuiping Center for Disease Prevention and Control
Yibin, Sichuan, China
Not Yet Recruiting
3
Xingwen Center for Disease Prevention and Control
Yibin, Sichuan, China
Not Yet Recruiting
Research Team
J
Jingsi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
11
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