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 range

6 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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