Actively Recruiting
Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
Led by Institute of Medical Biology, Chinese Academy of Medical Sciences · Updated on 2024-01-03
1500
Participants Needed
4
Research Sites
137 weeks
Total Duration
On this page
Sponsors
I
Institute of Medical Biology, Chinese Academy of Medical Sciences
Lead Sponsor
C
Centers for Disease Control and Prevention, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.
CONDITIONS
Official Title
Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 35 months at the time of enrollment
- Volunteers and their legal guardians or representatives must provide valid legal identification
- Legal guardians must understand and voluntarily agree to participate, signing informed consent and complying with study visits
- Axillary body temperature must be less than 37.3C before vaccination
You will not qualify if you...
- History of allergies to any vaccine component or serious adverse vaccine reactions
- Received any inactivated or subunit vaccine within 7 days or live attenuated vaccine within 14 days before first dose
- History or family history of convulsion, epilepsy, encephalopathy, or psychosis
- Known severe congenital malformation or developmental disorders
- Acute illness or use of certain medications within 3 days before first dose
- Genetic bleeding tendencies, coagulopathy, or bleeding disorders
- History of surgical removal of spleen or vital immune organs
- Blood loss 200mL or blood product transfusion within 3 months before first dose
- Use of investigational or unregistered products within 3 months before first dose
- Treatment with immunosuppressive agents within 6 months before first dose, except topical use
- Previous receipt of other EV71 vaccines
- Previous history of hand-foot-mouth disease
- Diagnosed infectious disease interfering with study (e.g., tuberculosis, viral hepatitis, HIV)
- Investigator's discretion for unsuitability
- Allergic conditions or severe adverse reactions after first dose
- Other exclusion reasons determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Chencang Center for Disease Prevention and Control
Baoji, Shaan XI, China
Not Yet Recruiting
2
Ningqiang Center for Disease Prevention and Control
Hanzhong, Shaan XI, China
Actively Recruiting
3
Fuping Center for Disease Prevention and Control
Weinan, Shaan XI, China
Not Yet Recruiting
4
Jingyang Center for Disease Prevention and Control
Xianyang, Shaan XI, China
Actively Recruiting
Research Team
W
Weijun Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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