Clinical trial NCT01069367: Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects
Official title: Open-label, Uncontrolled Postmarketing Study to Evaluate Immunogenicity, Safety and Tolerability of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Swine-Origin Influenza A H1N1 Virus
Keywords: Influenza A
H1N1 subtype
Children/adolescent
Vaccine
Adjuvant
Cell culture
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
timeFrame: 6 weeks
Secondary outcomes:
measure: Solicited reactions, AEs, vital signs, laboratory tests
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: CPC Clinic, Medipolis Medical Research Institute
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
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.