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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014