Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

October 7, 2015 updated by: Ology Bioservices

An Open-label Phase II Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Heterologous Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Young Adult Population (Follow Up to Study 810501)

The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

141

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • University Hospital, Department of Clinical Pharmacology, General Hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects who participated in Study 810501 will be eligible for participation in the study if they:

  • Completed the Day 42 visit in study 810501
  • Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
  • Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
  • Agree to keep a daily record of symptoms for the duration of the study
  • If female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

  • Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501
  • Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501
  • Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501
  • Are unable to lead an independent life as a result of either physical or mental handicap
  • Suffer from any kind of immunodeficiency since the second vaccination in Study 810501
  • Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
  • Have had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501
  • Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
  • Have undergone systemic corticoid therapy within 30 days prior to study entry
  • Have a functional or surgical asplenia
  • Have a known or suspected problem with alcohol or drug abuse
  • Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
  • Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator If female, are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ology Bioservices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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