A Single-centered, Open-labeled, Phase 4 Study of 2012-2013 Trivalent Seasonal Influenza Vaccine

Sinovac Biotech Co., Ltd1 site in 1 country202 target enrollmentNovember 2012

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: Sinovac Biotech Co., Ltd
Enrollment: 202
Locations: 1
Primary Endpoint: Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sinovac Biotech Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults aged 18-60 years old, and healthy old people aged \>60 years
•Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
•Not participate in any other clinical trials during the study
•Not receive any immunosuppressive agents during and one month prior to the study
•Be able to understand and sign the informed consent.

Exclusion Criteria

•Woman： Who breast-feeding or planning to become pregnant during the study
•Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
•Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
•Autoimmune disease or immunodeficiency
•Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
•Guillain-Barre Syndrome
•Women subjects with positive urinary pregnancy test
•Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
•Axillary temperature \>37.0 centigrade at the time of dosing
•Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment