A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children

Sinovac Biotech Co., Ltd1 site in 1 country1,614 target enrollmentJuly 2009

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: Sinovac Biotech Co., Ltd
Enrollment: 1614
Locations: 1
Primary Endpoint: Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

October 2009

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 male or female aged 3 and older
•Be able to show legal identity card for the sake of recruitment
•Volunteers or their guardians are able to understand and sign the informed consent

Exclusion Criteria

•Cases, cured cases and close contact of influenza A (H1N1) virus
•Women of pregnancy, lactation or about to be pregnant in 60 days
•Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
•Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
•Autoimmune disease or immunodeficiency
•Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
•Diabetes mellitus (type I or II), with the exception of gestational diabetes
•History of thyroidectomy or thyroid disease that required medication within the past 12 months
•Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
•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