Hand, Foot and Mouth Disease Clinical Trial
Official title:
A Phase III Clinical Trial With Randomized, Double-blinded, Controlled Design as Well as Bridging Design to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Children Aged 36-71 Months
Verified date | January 2020 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Status | Completed |
Enrollment | 900 |
Est. completion date | November 13, 2019 |
Est. primary completion date | June 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 71 Months |
Eligibility | Inclusion Criteria: - Healthy volunteers = 2 years old; - Proven legal identity; - Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment. Exclusion Criteria: - Prior vaccination with EV71 vaccine; - History of hand, foot and mouth disease; - History of allergy to any vaccine or vaccine ingredient, asthma, serious adverse reactions to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc; - Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; - Autoimmune disease or immunodeficiency/immunosuppressive; - Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness; - History of thyroidectomy, no spleen and functional spleen; - Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; - Receipt of any of the following products: 1. Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry 2. Blood products within 2 months prior to study entry 3. Any other investigational products (drug or vaccine)within 30 days prior to study entry 4. Any live attenuated vaccine within 14 days prior to study entry 5. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; - Acute disease or acute stage of chronic disease within 7 days prior to study entry; - Axillary temperature > 37.0 °C; - Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators. |
Country | Name | City | State |
---|---|---|---|
China | Yun County Center for Disease Control and Prevention | Lincang | Yunnan |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8 | Subjects whose pre-immune antibody titer < 1:8 and post-immune antibody titer = 1:8, or those whose pre-immune antibody titer = 1:8 and the increase of post-immune antibody level = 4 folds are considered seroconverted. | 30 days after two doses | |
Primary | The Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population | The susceptible population refer to the subjects whose pre-immune antibody titer <1:8 | 30 days after two doses | |
Secondary | The overall incidence of adverse reactions | After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. The solicited local symptoms include pain, induration, redness, swelling, rash, and pruritus. The solicited general adverse symptoms include allergy, fatigue, irritability, inappetence, vomiting, diarrhea, and fever. Unsolicited adverse events on day 0-30 were also reported, which include the unsolicited symptoms happened within 0-7 days, and any symptoms happened within the 8-28 days. Each AE case will be reviewed by the investigator to determine whether it was an adverse reaction (The vaccination-related AE). The incidence of adverse reactions=Number of subjects who have adverse reactions of any symptoms/number of all the subjects whose safety information are collected. | 0-30 days after each dose | |
Secondary | The incidence of the serious adverse events (SAE) | After each dose, the serious adverse events in the safety observation period will be reported. The SAE incidence=Number of subjects who have SAE of any symptoms/Number of subjects whose safety information are collected. | 0-30 days after each dose | |
Secondary | The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:16, 1:32, and 1:64 respectively | Subjects whose pre-immune antibody titer <1:16(1:32/1:64) and post-immune antibody titer =1:16(1:32/1:64), or those whose pre-immune antibody titer = 1:16(1:32/1:64) and the increase of post-immune antibody level = 4 folds are considered seroconverted. | 30 days after two doses | |
Secondary | The Geometric mean titer (GMT) of the EV71 neutralizing antibody | The GMT 30 days after two doses. | 30 days after two doses |
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