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Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

NCT01003288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2019-11-18

Study results available
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Summary

Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects

Conditions

  • Healthy

Interventions

BIOLOGICAL

Adjuvanted influenza H1N1split virion vaccine

Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A) \* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • Per Espen Akselsen, MD · Haukeland University Hospital

  • Haakon Sjursen, MD PhD · Haukeland University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-01-31
Completion
2014-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01003288 on ClinicalTrials.gov