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

• ClinicalTrials.gov Identifier: NCT01069367
• Recruitment Status: Completed
• First Posted: February 17, 2010
• Last Update Posted: December 1, 2016
• Sponsor: Novartis Vaccines
• Information provided by (Responsible Party): Novartis ( Novartis Vaccines )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Swine-Origin Influenza A H1N1 Virus	Biological: Emulsion, Cell Culture-based, influenza HA vaccine H1N1	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: March 2010
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: April 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm:1	Biological: Emulsion, Cell Culture-based, influenza HA vaccine H1N1; Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)

Outcome Measures

Primary Outcome Measures :

1. Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6 [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. Solicited reactions, AEs, vital signs, laboratory tests [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 61 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Japan

CPC Clinic, Medipolis Medical Research Institute

Kagoshima, Japan

Sponsors and Collaborators

Novartis Vaccines

Investigators

• Study Chair: Novartis Vaccines; Novartis Vaccines

More Information

Publications of Results:

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.

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT01069367
• Other Study ID Numbers: V110_10
• First Posted: February 17, 2010
• Last Update Posted: December 1, 2016
• Last Verified: January 2012

Keywords provided by Novartis ( Novartis Vaccines ):

Influenza A; H1N1 subtype; Children/adolescent; Vaccine; Adjuvant; Cell culture

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases