Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects
1 other identifier
interventional
100
1 country
1
Brief Summary
This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety \& tolerability of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedDecember 1, 2016
January 1, 2012
1 month
February 15, 2010
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
6 weeks
Secondary Outcomes (1)
Solicited reactions, AEs, vital signs, laboratory tests
6 weeks
Study Arms (1)
Arm:1
EXPERIMENTALInterventions
Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)
Eligibility Criteria
You may qualify if:
- Healthy Japanese aged over 60 years
You may not qualify if:
- Any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease)
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients
- Administration of swine influenza (A/H1N1) vaccine prior to Day 1 or documented confirmed or suspected swine influenza disease
- History of progressive or sever neurological disorders
- Known or suspected impairment/alteration of immune function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CPC Clinic, Medipolis Medical Research Institute
Kagoshima, Japan
Related Publications (1)
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.
PMID: 22472791RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2010
First Posted
February 17, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
December 1, 2016
Record last verified: 2012-01