A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants

Sinovac Biotech Co., Ltd1 site in 1 country310 target enrollmentDecember 2009

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: Sinovac Biotech Co., Ltd
Enrollment: 310
Locations: 1
Primary Endpoint: Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

May 2010

Last Updated

13 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 between 6 and 35 months
•Full-term birth, birth weight 2,500 grams or more
•provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria

•Cases, cured cases and close contact of influenza A (H1N1) virus
•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
•Symptoms of acute infection within a week
•Autoimmune disease or immunodeficiency
•Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
•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
•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
•History or family history of convulsions, epilepsy, brain disease and psychiatric
•Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen