NCT00950456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 9, 2015

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

July 30, 2009

Last Update Submit

October 7, 2015

Conditions

InfluenzaPandemic Influenza

Study Arms (1)

H1N1 Pandemic Influenza Vaccine

Subjects will be enrolled and vaccinated according to national policy and standard practice.

Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)

Interventions

H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)BIOLOGICAL

It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.

Also known as: CELVAPAN
H1N1 Pandemic Influenza Vaccine

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

General Practice

Bludenz, 6700, Austria

Location

General Practice

Fulpmes, 6166, Austria

Location

General Practice

Hall in Tirol, 6060, Austria

Location

General Practice

Innsbruck, 6020, Austria

Location

Practice for Travel Medicine

Innsbruck, 6020, Austria

Location

City Council (Magistrat) Klagenfurt (Health & Food Department)

Klagenfurt, 9020, Austria

Location

General Practice

Kufstein, 6330, Austria

Location

General Practice

Mariapfarr, 5571, Austria

Location

General Practice

Oberperfuss, 6173, Austria

Location

General Practice

Salzburg, 5020, Austria

Location

General Practice

Telfs, 6410, Austria

Location

Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine

Vienna, 1090, Austria

Location

Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

Location

Hanusch Hospital

Vienna, 1100, Austria

Location

Wiener Gebietskrankenkasse (Health insurance center Vienna)

Vienna, 1100, Austria

Location

General Practice

Voitsberg, 8570, Austria

Location

General Practice

Wels, 4600, Austria

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Baxter BioScience Medical Director

    Baxter Healthcare Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

October 9, 2015

Record last verified: 2011-05

Locations

AU(17)