Hand, foot and mouth disease (HFMD)
Conditions
Interventions
Adult low-dose group (>=18 y):recombinant enterovirus 71 vaccine with 10ug virus-like particles (VLPs) protein per dose
Adult high-dose group (>=18 y):recombinant enterovirus 71 vaccine with 20ug virus-like particles (VLPs) protein per dose
Adult low-dose placebo group (>=18 y):placebo
Adult high-dose placebo group (>=18 y):placebo
juvenile low-dose group (6~17 y):recombinant enterovirus 71 vaccine with 10ug virus-like particles (VLPs) protein per dose
juvenile high-dose group (6~17 y):recombinant enterovirus 71 vaccine with 20ug virus-like particles (VLPs) protein per dose
juvenile low-dose placebo group (6~17 y):placebo
juvenile high-dose placebo group (6~17 y):placebo
young child low-dose group (36~71 m):recombinant enterovirus 71 vaccine with 10µg virus-like particles (VLPs) protein per dose
young child high-dose group (36~71 m):recombinant enterovirus 71 vaccine with 20µg virus-like particles (VLPs) protein per dose
young child low-dose placebo group (36~71 m):placebo
young child high-dose placebo group (36~71 m):placebo
young child low-dose control group (36~71 m):inactivated enterovirus 71 vaccine
young child high-dose control group (36~71 m):inactivated enterovirus 71 vaccine
infant-young child low-dose group (6~35 m):recombinant enterovirus 71 vaccine with 10µg virus-like particles (VLPs) protein per dose
infant-young child high-dose group (6~35 m):recombinant enterovirus 71 vaccine with 20µg virus-like particles (VLPs) protein per dose
infant-young child low-dose placebo group (6~35 m):placebo
infant-young child high-dose placebo group (6~35 m):placebo
infant-young child low-dose control group (6~35 m): inactivated enterovirus 71 vaccine
infant-young child high-dose control group (6~35 m):inactivated enterovirus 71 vaccine
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
0.5 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. In-residence healthy individuals aged over 6 months; 2. Subjects aged 6 months to 17 years old and their guardians can provide legal identification; subjects aged over 18 years old can provided their legal identification; 3. The minors and their legal guardians voluntarily agree to participate in this study and sign the Informed Consent Form (in which both of minors aged 8 to 17 years old and their legal guardians are required to sign); Adults voluntarily participate with informed consent and sign the Informed Consent Form; 4. Subjects aged 6 months to 14 years old with temperature <37.5 degree.Subjects aged over 14-year-old with temperature <37.3 degree; 5. Subjects and/or their guardians allow to comply with the requirements of the protocol; 6. Available for all visits scheduled in this study and able to bring in the pre-and post-immunization blood tests.
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for the first dose: (1) Had a history of hand, foot and mouth disease (HFMD) or herpangina; (2) Had received vaccine against EV 71 or participated in clinical trials of EV 71 vaccine; (3) Had history of serious side effects on the vaccine (e.g. urticaria, dyspnea, angioneuroedema), or allergic to any ingredient of vaccine (e.g. Histidine, polysorbate, aluminum phosphate, sodium borate, amorphous hydroxyphosphate aluminum sulfate adjuvant and water for injection); (4) Had a history of asthma and were in the attack period before vaccination; (5) Adult women who had a positive blood pregnancy testing outcome, or women who are breastfeeding, during pregnant, or plan to conceive within 60 days; (6) Birth weight = 14 days) treatment with cytotoxic or immunosuppressive drugs and inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid treatment for acute non-concurrent dermatitis) within 6 months; Or plan to receive such products within the next 2 months; (17) Receiving the anti-TB prevention or therapy; (18) The laboratory indicators specified in this study protocol are abnormal (excluding the non-clinically significant); (19) Unable to follow the study schedule, or plan to permanently relocation, or long-term departure during study period; (20) Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives. 2. Exclusion Criteria for the second dose: (1) Meeting the exclusion criteria stated in the exclusion criteria for first dose (Except No.14 and No.15 ) (2) Had Grade 3 and above acute allergic reaction related to the first dose; (3) Subjects voluntarily withdraw from the study; (4) Other exclusion c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediately adverse events;Solicited AEs;Unsolicited AEs;Serious Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| neutralizing antibody against enterovirus type 71; | — |
Countries
China
Contacts
Public ContactZhaojun Mo
Guangxi Center for Disease Control and Prevention
Outcome results
None listed