Back to resultsA/H1N1 Immunogenicity and Safety in Adults
Primary Purpose
Influenza, Pandemic Influenza
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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
Sites / Locations
- Sanatorium Leech
- ClinPharm International GmbH
- Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
- University Hospital, Department of Clinical Pharmacology
- Praxis Regner Schmitt
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1/Dose Level A
Cohort 1/Dose B
Cohort 2/Dose C
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959465
Brief Title
A/H1N1 Immunogenicity and Safety in Adults
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ology Bioservices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Pandemic Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1/Dose Level A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 1/Dose B
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2/Dose C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Intervention Description
Two injections at a 21-day interval (Days 1 and 22)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Aichinger, MD
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Sanatorium Leech
City
Graz
ZIP/Postal Code
8010
Country
Austria
Facility Name
ClinPharm International GmbH
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Hospital, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Praxis Regner Schmitt
City
Mainz
ZIP/Postal Code
55116
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A/H1N1 Immunogenicity and Safety in Adults
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