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Clinical Trials/ISRCTN53344556
ISRCTN53344556
Completed
Phase 1

Randomised, Double-blinded, Placebo-controlled Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects

Sinovac Biotech Co. Ltd (China)0 sites120 target enrollmentAugust 17, 2006
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Sinovac Biotech Co. Ltd (China)
Enrollment
120
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16980114 (added 03/05/2019)

Registry
who.int
Start Date
August 17, 2006
End Date
June 5, 2006
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sinovac Biotech Co. Ltd (China)

Eligibility Criteria

Inclusion Criteria

  • •1\. Males and females, aged from 18 to 60 years old
  • •2\. Able to provide proof of identity to the satisfaction of the study clinician completing the enrolment process
  • •3\. Able and willing to complete the informed consent process

Exclusion Criteria

  • •1\. Women who are breast\-feeding or planning to become pregnant during the following 210 days of study participation
  • •2\. Subjects who engage in the occupations of culturist, slaughter, sale and forwarder of any avian organisms
  • •3\. Subject has a medical history of any of the following:
  • •a. allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein etc.
  • •b. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  • •c. autoimmune disease or immunodeficiency
  • •d. asthma that is unstable or required emergency care, urgent care, hospitalisation or intubation during the past two years or that requires the use of oral or intravenous corticosteroids
  • •e. diabetes mellitus (type I or II), with the exception of gestational diabetes
  • •f. history of thyroidectomy or thyroid disease that required medication within the past 12 months
  • •g. serious angioedema episodes within the previous three years or requiring medication in the previous two years

Outcomes

Primary Outcomes

Not specified

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