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Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00734734
First received: August 13, 2008
Last updated: December 21, 2015
Last verified: December 2015

August 13, 2008
December 21, 2015
June 2008
July 2008   (final data collection date for primary outcome measure)
  • Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.

    Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.

    The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).

  • Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ] [ Designated as safety issue: No ]

    Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).

    The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years).

  • Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).

    This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).

  • Number of Participants Who Reported Solicited Local and Systemic Reactions [ Time Frame: 0 to 3 days post-vaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.
Evaluation of immunogenicity of the NH 2008/09 influenza vaccine formulation, by means of Single Radial Hemolysis assay, at day 0 and day 21 following vaccination [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00734734 on ClinicalTrials.gov Archive Site
Not Provided
Evaluation of clinical tolerability and safety of the influenza vaccine [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009, When Administered to Elderly Subjects
Trial for annual approval of interpandemic influenza vaccines
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Interpandemic Influenza
Biological: Seasonal Influenza Vaccine
1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation
Experimental: 1
Intervention: Biological: Seasonal Influenza Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2008
July 2008   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 65 years of age or older
  • Mentally competent
  • Willing and able to give written informed consent prior to study entry
  • Able to comply with all the study requirements
  • In general good health

Key Exclusion Criteria:

  • Any serious chronic or acute disease
  • History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
  • Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
  • Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
  • A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
  • Within the past 12 months, they have received more than one injection of influenza vaccine
  • Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
  • Within the past 4 weeks participants had received another vaccine; any investigational agent
  • An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days
Both
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00734734
V70P7S, 2008-001047-19
Not Provided
Not Provided
Not Provided
Novartis Vaccines
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
December 2015

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