A/H1N1 Immunogenicity and Safety in Adults

October 7, 2015 updated by: Ology Bioservices

An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older

The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 2
  • Phase 1

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
      • Graz, Austria, 8010
        • Sanatorium Leech
      • Vienna, Austria, 1090
        • ClinPharm International GmbH
      • Vienna, Austria, 1090
        • Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
      • Vienna, Austria, 1090
        • University Hospital, Department of Clinical Pharmacology
  • Germany
      • Mainz, Germany, 55116
        • Praxis Regner Schmitt

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
  • Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
  • Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
  • Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
  • If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

  • Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
  • Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
  • Subject has inherited or acquired immune deficiency
  • Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1/Dose Level A
Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)
Experimental: Cohort 1/Dose B
Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)
Experimental: Cohort 2/Dose C
A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval.
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
Time Frame: 42 days
42 days

Collaborators and Investigators

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

Sponsor

Ology Bioservices

Investigators

  • Study Director: Gerald Aichinger, MD, Baxter Healthcare Corporation

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

August 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820902
  • EUDRACT Number 2009-013394-17

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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