Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00481065
First received: May 31, 2007
Last updated: December 31, 2013
Last verified: December 2013

May 31, 2007
December 31, 2013
April 2007
December 2008   (final data collection date for primary outcome measure)
  • Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]

    Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH).

    Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area.

    Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.

  • Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine [ Time Frame: 21 days after second and third vaccinations (day 22 and day 43) ] [ Designated as safety issue: No ]
    Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.
  • Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) [ Time Frame: 21 days after second vaccination (day 43) ] [ Designated as safety issue: No ]

    seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.

    Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.

  • Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]

    seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.

    Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.

  • Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]

    seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.

    Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.

  • Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) [ Time Frame: 21 days after second vaccination (day 43) ] [ Designated as safety issue: No ]
    For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.
  • Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]
    For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
  • Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]
    For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
  • Safety Objective:safety of the administration of one, two or three doses of an H5N1 influenza vaccine with a seasonal trivalent vaccine.
  • Primary Immunogenicity Objective:magnitude of antibody responses to one, two or three doses of an H5N1 influenza vaccine and a seasonal trivalent vaccine
Complete list of historical versions of study NCT00481065 on ClinicalTrials.gov Archive Site
  • Number of Subjects Reporting Local and Systemic Reactions by Vaccination [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: Yes ]
    The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.
  • Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [ Time Frame: 21 days after booster vaccination (day 403) ] [ Designated as safety issue: No ]

    Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.

    The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382.

  • Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [ Time Frame: 21 days after booster vaccination (day 403) ] [ Designated as safety issue: No ]
    For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.
Secondary Immunogenicity ObjectiveKinetics of antibody responses to one booster dose of H5N1-vaccine when given 12 months after the first or second dose
Not Provided
Not Provided
 
Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects

This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pandemic
  • Avian Influenza
  • Biological: MF59-eH5N1
  • Biological: eTIV_a
  • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: Concomitant alone
    1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382.
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: Concomitant +Mixed
    1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: Concomitant +MF59-eH5N1
    1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: Mixed
    1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: Mixed and mixed
    1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: Mixed+MF59-eH5N1
    1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: MF59-eH5N1+eTIV_a
    1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a
  • Experimental: eTIV_a+MF59-eH5N1
    1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Interventions:
    • Biological: MF59-eH5N1
    • Biological: eTIV_a
    • Biological: MF59-eH5N1 + eTIV_a

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00481065
V87P5
Not Provided
Novartis
Novartis
Novartis Vaccines
Study Chair: Novartis Drug Information Services +1 800 244 7668 Novartis
Novartis
December 2013

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