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
  Purpose

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.


Condition Intervention Phase
Pandemic
Avian Influenza
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 405
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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
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
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
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
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
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481065

Locations
Colombia
Bogotà, Colombia
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Drug Information Services +1 800 244 7668 Novartis
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00481065     History of Changes
Other Study ID Numbers: V87P5
Study First Received: May 31, 2007
Results First Received: August 26, 2011
Last Updated: December 31, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:
Bird flu
influenza vaccine
Seasonal influenza vaccine
Prepandemic vaccine

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014