WithdrawnPhase 2

Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants

Stopped: Based on the previous study results, inactivated EV71 vaccine with aluminum adjuvant was elected to be used for the efficacy Phase III study.

China0Started 2011-09

Plain-language 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

Who can participate

Age range6 Months – 11 Months

SexALL

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Inclusion criteria

✓. 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
✓. Provided legal identification for the sake of recruitment.
✓. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
✓. Birth weight more than 2500 grams

Exclusion criteria

✕. History of Hand-foot-mouth Disease
✕. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
✕. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
✕. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
✕. Epilepsy, seizures or convulsions history, or family history of mental illness
✕. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
✕. History of asthma, angioedema, diabetes or malignancy
✕. History of thyroidectomy or thyroid disease that required medication within the past 12 months

What they're measuring

Neutralization antibody geometric mean titer in infants 28 days after immunization with 400U vaccine with or without aluminium hydroxide adjuvant

Timeframe: 2 months

Trial details

NCT IDNCT01812135

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

View on ClinicalTrials.gov More Infection, Viral, Enterovirus trials