Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
NCT ID: NCT00620815
Last Updated: 2016-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
601 participants
INTERVENTIONAL
2007-11-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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T/P-A
One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine
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.
A/P-T
One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22.
Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1
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.
A/S-A
One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22.
Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine
Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.
T/P-A (V2 blood draw)
One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by a blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22.
MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine
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.
A/P-T (V2 blood draw)
One dose of the Aflunov(A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by additional blood draw at visit 2 (V2) prior to the Tetravalent influenza vaccination (T) on day 22.
Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1
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.
A/S-A (V2 blood draw)
One dose of Aflunov (A)and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed by an additional blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22.
Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine
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.
Interventions
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MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine
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
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
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines and Diagnostics
Role: STUDY_CHAIR
Novartis
Locations
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ATRIUM Gesundheitszentrum;
Holzkirchen, , Germany
International Medicine & Public Health Dept. of Infect. Diseases
Munich, , Germany
Countries
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References
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Herbinger KH, von Sonnenburg F, Nothdurft HD, Perona P, Borkowski A, Fragapane E, Nicolay U, Clemens R. A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59(R): adjuvanted, pre-pandemic, A/H5N1 vaccine and trivalent seasonal influenza vaccine in healthy adults. Hum Vaccin Immunother. 2014;10(1):92-9. doi: 10.4161/hv.26495. Epub 2013 Sep 20.
Other Identifiers
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2007-002712-25
Identifier Type: -
Identifier Source: secondary_id
V101P1
Identifier Type: -
Identifier Source: org_study_id
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