Infection, Viral, Enterovirus
Conditions
Brief summary
A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant
Interventions
BIOLOGICAL400 U EV71 vaccine with adjuvant
400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females, aged from 6 to 11 months 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 and/or parent(s)/legal guardian(s) are able to understand and sign informed consents. 4. Birth weight more than 2500 grams
Exclusion criteria
1. History of Hand-foot-mouth Disease 2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine 3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition 5. Epilepsy, seizures or convulsions history, or family history of mental illness 6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency 7. History of asthma, angioedema, diabetes or malignancy 8. History of thyroidectomy or thyroid disease that required medication within the past 12 months 9. 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 10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen 11. Acute illness or acute exacerbation of chronic disease within the past 7 days 12. 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) 13. History of any blood products within 3 months 14. Administration of any live attenuated vaccine within 28 days 15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days 16. Axillary temperature \> 37.0 centigrade before vaccination 17. Abnormal laboratory parameters before vaccination 18. 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 | Description |
|---|---|---|
| Neutralization antibody geometric mean titer in infants 28 days after immunization with 400U vaccine with or without aluminium hydroxide adjuvant | 2 months | Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8 |
Secondary
| Measure | Time frame |
|---|---|
| The rates and severity of solicited and unsolicited adverse events in infants following immunization as a Measure of Safety and Tolerability | 2 months |
Countries
China
Outcome results
None listed