Back to resultsSingle-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza A, H1N1 subtype, Adult, Vaccine, Adjuvant, Swine-Origin Influenza A H1N1 Virus
Eligibility Criteria
Inclusion Criteria:
- Healthy Japanese adults aged 20 to 60 years
Exclusion Criteria:
- History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
- Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
- Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
- History of progressive or severe neurological disorders
Sites / Locations
- Osaka pref.
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm 1
Arm 2
Arm Description
Dose ranging
Dose ranging
Outcomes
Primary Outcome Measures
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
Secondary Outcome Measures
AEs, vital signs, laboratory tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00996138
Brief Title
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
Official Title
A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza A, H1N1 subtype, Adult, Vaccine, Adjuvant, Swine-Origin Influenza A H1N1 Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
Dose ranging
Arm Title
Arm 2
Arm Type
Other
Arm Description
Dose ranging
Intervention Type
Biological
Intervention Name(s)
Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
Intervention Description
High dose group and low dose group of adjuvanted vaccines
Primary Outcome Measure Information:
Title
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
AEs, vital signs, laboratory tests
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Japanese adults aged 20 to 60 years
Exclusion Criteria:
History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
History of progressive or severe neurological disorders
Facility Information:
Facility Name
Osaka pref.
City
Kagoshima pref.
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22472791
Citation
Fukase H, Furuie H, Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Yotsuyanagi H, Kusadokoro H, Sawata H, Nakura N, Lattanzi M. Assessment of the immunogenicity and safety of varying doses of an MF59(R)-adjuvanted cell culture-derived A/H1N1 pandemic influenza vaccine in Japanese paediatric, adult and elderly subjects. Vaccine. 2012 Jul 13;30(33):5030-7. doi: 10.1016/j.vaccine.2012.03.053. Epub 2012 Apr 1.
Results Reference
result
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Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
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