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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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01069367
First received: February 15, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Flu
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Solicited reactions, AEs, vital signs, laboratory tests [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069367

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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01069367     History of Changes
Other Study ID Numbers: V110_10
Study First Received: February 15, 2010
Last Updated: January 4, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on May 21, 2013