Actively Recruiting
Phase I Trial to Evaluate Safety and Preliminary Immune Response of Diphtheria-Tetanus-acellular Pertussis Vaccine in Children Aged 2 Months to 6 Years
Led by Institute of Medical Biology, Chinese Academy of Medical Sciences · Updated on 2024-01-03
460
Participants Needed
3
Research Sites
98 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
Researchers are conducting a randomized, single-blind, active-controlled phase I clinical trial to evaluate the safety and early immune response of a combined Diphtheria-Tetanus-acellular Pertussis (DTacP) vaccine in children aged 2 months to 6 years. The study aims to assess adverse events shortly after vaccination and up to 12 months later, as well as measure antibody levels to various components of the vaccine. The trial includes infants, toddlers, and children, with careful monitoring of immune response and safety outcomes. The trial is divided into three stages by age groups: children aged 6 years, toddlers aged 18-24 months, and infants aged 2 to 3 months. Participants are randomly assigned to receive either the DTacP vaccine or other vaccines such as DT, DTaP, or Pentaxim in different dosing schedules and injection sites. Children and toddlers receive a single injection on Day 0, while infants receive three doses over 2 to 4 months following specific immunization schedules. Safety reviews occur after each stage to decide progression. Participants will be monitored closely for adverse events through diaries, phone calls, and face-to-face visits for up to 12 months after vaccination. Blood, urine, and other lab tests will be performed before and after vaccination to assess safety and immune responses. Antibody levels against diphtheria, tetanus, pertussis, and poliovirus will be measured before vaccination, 30 days after, and for infants, again at 12 months. The study duration varies by group but may last up to 16 months for infants.
CONDITIONS
Brief 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 to 3 months at enrollment
- Children aged 6 years must have received four doses of diphtheria, tetanus, and pertussis combined vaccine and not yet received diphtheria-tetanus combined vaccine
- Toddlers aged 18-24 months must have received three doses of diphtheria, tetanus, and pertussis combined 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 guardians must provide valid legal identification
- Guardians must understand the study, give informed consent, and comply with study requirements
- Toddlers and infants must be born full term (37-42 weeks) with birth weight ≥2500g
- Axillary body temperature must be no more than 37.3°C
You will not qualify if you...
- Diagnosis of pertussis, tetanus, or diphtheria disease
- Toddlers and infants with abnormal labor history, asphyxia, nervous system damage, or pathological jaundice
- Allergy to any vaccine component or history of serious allergic reactions
- Vaccination with inactivated or live vaccines within specified days before study vaccine
- Acute illness or exacerbation of chronic illness within 3 days before first dose
- History or family history of seizures, epilepsy, encephalopathy, or psychiatric disorders
- Major congenital malformations, developmental disabilities, serious chronic diseases, or malignant tumors
- Genetic bleeding disorders or coagulopathy
- Infectious diseases interfering with the study, such as tuberculosis, hepatitis, or HIV
- History of needle or blood sickness or inability to tolerate venipuncture
- Surgical removal of spleen or vital organs
- Significant blood loss or blood transfusion within 3 months before first dose
- Use of immunosuppressive treatment within 6 months before first dose
- Participation in other clinical trials or use of investigational products within 3 months
- Abnormal vital signs or lab tests with clinical significance
- Investigator's discretion deeming subject unsuitable
- Serious adverse events related to prior vaccine doses
- Vaccination with other diphtheria-tetanus-pertussis or polio vaccines during study period
- Ineligibility or exclusion criteria met after prior dose
- Investigator's discretion deeming subject unsuitable for further doses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for vaccination; approximately 12 months total participation
Participants aged 6 years and 18-24 months receive a single vaccine dose and are observed for safety. Adverse events are monitored from Day 0 to Day 30 after vaccination.
1 vaccination visit with 30-minute observation and multiple follow-up contacts over 12 months
Duration - 2 to 4 months for vaccination; approximately 15 to 16 months total participation
Participants aged 2 to 3 months receive three doses of vaccine according to specific immunization schedules. Adverse events are monitored from Day 0 to Day 30 after each dose, with follow-up until 18 months old.
3 vaccination visits with 30-minute observation each and follow-up contacts up to 18 months old
Duration - Up to 12 months after last vaccination
Participants are monitored for serious adverse events up to 12 months after last vaccination. Blood and urine tests are performed before vaccination and at specified times after doses for safety and immune response assessment.
Blood and urine tests on Day 0 and Day 4 after doses; immunogenicity blood draws before vaccination, 30 days after vaccination, and around 12 months after primary vaccination for infants
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
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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