Infection; Viral, Enterovirus
Conditions
Brief summary
A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults
Detailed description
A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults
Interventions
BIOLOGICALInactivated Enterovirus Type 71 Vaccine
A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
OTHERPlacebo
Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females, aged from 18 to 49 years old. Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. Provided legal identification for the sake of recruitment. 3. Subjects are able to understand and sign informed consents.
Exclusion criteria
1. Histroy of Hand-foot-mouth Disease 2. Women of lactation, pregnancy or about to be pregnant in 60 days 3. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine 4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 5. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition 6. Epilepsy, seizures or convulsions history, or family history of mental illness 7. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency 8. History of asthma, angioedema, diabetes or malignancy 9. History of thyroidectomy or thyroid disease that required medication within the past 12 months 10. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws 11. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen 12. Acute illness or acute exacerbation of chronic disease within the past 7 days 13. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) 14. History of any blood products within 3 months 15. Administration of any live attenuated vaccine within 28 days 16. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days 17. Axillary temperature \> 37.0 centigrade before vaccination 18. Abnormal laboratory parameters before vaccination 19. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the inactivated Enterovirus Type 71 Vaccine in adults by different doses | 3 months |
Countries
China
Outcome results
None listed