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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines ) Identifier:
First received: February 15, 2010
Last updated: November 30, 2016
Last verified: January 2012
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 Intervention Phase
Swine-Origin Influenza A H1N1 Virus
Biological: Emulsion, Cell Culture-based, influenza HA vaccine H1N1
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6 [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Solicited reactions, AEs, vital signs, laboratory tests [ Time Frame: 6 weeks ]

Enrollment: 100
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

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

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
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Please refer to this study by its identifier: NCT01069367

CPC Clinic, Medipolis Medical Research Institute
Kagoshima, Japan
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Additional Information:
Responsible Party: Novartis Vaccines Identifier: NCT01069367     History of Changes
Other Study ID Numbers: V110_10
Study First Received: February 15, 2010
Last Updated: November 30, 2016

Keywords provided by Novartis:
Influenza A
H1N1 subtype
Cell culture

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017