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Clinical Trials/NCT00950456
NCT00950456CompletedNot Applicable

A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities

Resilience Government Services, Inc.7 sites in 1 country3,216 target enrollmentStarted: November 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,216
Locations
7
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
  • •They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
  • •They are 2 months of age or older at the time of first vaccine administration
  • •Their medical history is available
  • •The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
  • •They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law

Exclusion Criteria

  • •Male and female subjects will be excluded from participation in this study if:
  • •They have already been administered another H1N1 pandemic vaccine
  • •They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)

Investigators

Sponsor Class
Industry

Study Sites (7)

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