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Completed

NCT Number: NCT00620815

Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above

Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)

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Key information

Conditions

Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ATRIUM Gesundheitszentrum;, Holzkirchen, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects (aged 18 years and above) who have signed an informed consent form

Exclusion criteria

  • Any acute or chronic illness
  • Receipt of seasonal influenza vaccine for the current season 2007/2008
  • Known or suspected impairment/alteration of immune function
  • Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
  • Any serious disease
  • Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
  • Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination

Treatment and study plan

MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine

Biological

Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.

Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1

Biological

Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.

Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine

Biological

Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.

Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1

Biological

Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.

Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine

Biological

Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine

Biological

Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

Primary outcomes

  1. To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.

    Time frame: up to day 43

    The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence.

    The statistical analysis was done based on the GMRs.

Secondary outcomes

  1. Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination

    Time frame: Up to 7 days after 1st vaccination

    Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently.

  2. Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination

    Time frame: Up to 7 days after 2nd vaccination

    Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.

  3. Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.

    Time frame: 7 days after 1st and 2nd vaccinations each

    Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.

  4. Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain

    Time frame: up to day 43

    Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion.

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

    Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH)

  5. Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2

    Time frame: Up to 43 days

    Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay.

  6. Antibody Response Determined by HI and MN Assay.

    Time frame: Up to 43 days

    Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay.

  7. Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.

    Time frame: Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)

    The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects.

    Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC.

  8. Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit

    Time frame: Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)

    Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with:

    Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)].

    The change in frequency of T-cells was measured.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II, Randomized, Placebo-controlled, Observer-blind, Multi Center Study on the Safety and Immunogenicity of Novartis Tetravalent Influenza Vaccine (Containing Both Interpandemic Strains and H5N1) in Adults Aged 18 Years and Above

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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