A Double-blind and Randomized, Phase II -02 Study With Inactivated EV71 Vaccines in Healthy Infants

Sinovac Biotech Co., Ltd1 site in 1 countrySeptember 2011

ConditionsInfection, Viral, Enterovirus

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Infection, Viral, Enterovirus
Sponsor: Sinovac Biotech Co., Ltd
Locations: 1
Primary Endpoint: Neutralization antibody geometric mean titer in infants 28 days after immunization with 400U vaccine with or without aluminium hydroxide adjuvant
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

December 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinovac Biotech Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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
•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
•Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen

Outcomes

Primary Outcomes

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

Time Frame: 2 months

Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8

Secondary Outcomes

The rates and severity of solicited and unsolicited adverse events in infants following immunization as a Measure of Safety and Tolerability(2 months)