Back to resultsH5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Participant is 65 years or older at the time of screening.
- Participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
- Participant is physically and mentally capable of participating in the study.
- Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
- Participant has a history of infection with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
- Participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
- Participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder.
- Participant has any inherited or acquired immunodeficiency.
- Participant has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
- Participant has a history of severe allergic reactions or anaphylaxis.
- Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating.
- Participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry.
- Participant has donated blood or plasma within 30 days prior to study entry.
- Participant has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study.
- Participant has a functional or surgical asplenia.
- Participant has a known or suspected problem with alcohol or drug abuse.
- Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
- Participant is a family member or employee of the investigator.
- Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.
Sites / Locations
- PS Clinic
- Osaka Pharmacology Clinical Research Hospital (OPHAC Hospital)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Influenza Vaccine
Arm Description
One dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection into the musculus deltoideus in the upper arm on Day 1 and 22.
Outcomes
Primary Outcome Measures
Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)
Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2
Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination
'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample (≤4mm^2) or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.
Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline
Secondary Outcome Measures
Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2
Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination
'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample [≤4mm^2] or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.
Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline
Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20
Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination
'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.
Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating either ≥4-fold titer increase compared to baseline if above detection limit OR ≥ 20 titer after vaccination if baseline titer is below detection limit
Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline
Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40
Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination
'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline
Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline
Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations
Number of participants with fever, malaise or shivering with onset within 7 days after the first and second vaccinations
Frequency and severity of all adverse events (AEs) observed during the entire study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01774032
Brief Title
H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older
Official Title
An Open-Label Phase 3 Study to Assess Immunogenicity and Safety of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Japanese Elderly Population Aged 65 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ology Bioservices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza Vaccine
Arm Type
Experimental
Arm Description
One dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection into the musculus deltoideus in the upper arm on Day 1 and 22.
Intervention Type
Biological
Intervention Name(s)
H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Primary Outcome Measure Information:
Title
Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)
Description
Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2
Time Frame
Day 43 (42 days after first vaccination, 21 days after second vaccination)
Title
Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination
Description
'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample (≤4mm^2) or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.
Time Frame
Day 43 (42 days after first vaccination, 21 days after second vaccination)
Title
Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline
Time Frame
Day 43 (42 days after first vaccination, 21 days after second vaccination)
Secondary Outcome Measure Information:
Title
Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Description
Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2
Time Frame
Days 22 and 202
Title
Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination
Description
'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample [≤4mm^2] or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.
Time Frame
Days 22 and 202
Title
Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline
Time Frame
Days 22 and 202
Title
Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Description
Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination
Description
'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating either ≥4-fold titer increase compared to baseline if above detection limit OR ≥ 20 titer after vaccination if baseline titer is below detection limit
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Description
Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination
Description
'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Time Frame
Days 22, 43 and 202
Title
Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline
Time Frame
Days 22, 43 and 202
Title
Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations
Time Frame
Through study day 43
Title
Number of participants with fever, malaise or shivering with onset within 7 days after the first and second vaccinations
Time Frame
Days 1-8 and days 22-29
Title
Frequency and severity of all adverse events (AEs) observed during the entire study period
Time Frame
Throughout the study period- 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant is 65 years or older at the time of screening.
Participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
Participant is physically and mentally capable of participating in the study.
Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
Participant has a history of infection with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
Participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
Participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder.
Participant has any inherited or acquired immunodeficiency.
Participant has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
Participant has a history of severe allergic reactions or anaphylaxis.
Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating.
Participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry.
Participant has donated blood or plasma within 30 days prior to study entry.
Participant has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study.
Participant has a functional or surgical asplenia.
Participant has a known or suspected problem with alcohol or drug abuse.
Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
Participant is a family member or employee of the investigator.
Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirjhar Chatterjee, MD
Organizational Affiliation
Baxter Innovations GmbH
Official's Role
Study Director
Facility Information:
Facility Name
PS Clinic
City
Fukuoka City
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Osaka Pharmacology Clinical Research Hospital (OPHAC Hospital)
City
Osaka City
ZIP/Postal Code
532-0003
Country
Japan
12. IPD Sharing Statement
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H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older
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