Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01069367
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

February 15, 2010
February 17, 2010
December 1, 2016
March 2010
April 2010   (Final data collection date for primary outcome measure)
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6 [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT01069367 on Archive Site
Solicited reactions, AEs, vital signs, laboratory tests [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects
Open-label, Uncontrolled Postmarketing Study to Evaluate Immunogenicity, Safety and Tolerability of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Elderly Subjects
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.
This is an open-label, uncontrolled post-marketing study of the cell-derived A/H1N1 influenza HA vaccine. Subjects received 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75_halfMF59). All vaccination were administered IM in the deltoid muscle, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. Blood samples were collected at baseline (day1), 3 weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) assay. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e. Day 1 to Day 7 and Day 22 to Day 28). All AEs, SAEs, and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Swine-Origin Influenza A H1N1 Virus
Biological: Emulsion, Cell Culture-based, influenza HA vaccine H1N1
Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)
Experimental: Arm:1
Intervention: Biological: Emulsion, Cell Culture-based, influenza HA vaccine H1N1
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®-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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Japanese aged over 60 years

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
61 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP