- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644059
Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to <72 Months
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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East Vaanta, Finland, 01300
- East Vantaa Clinic
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Espoo, Finland, 02100
- Espoo Vaccine Research Clinic
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Helsinki, Finland, 00100
- Helsinki South Vaccine Research Clinic
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Helsinki, Finland, 00930
- Helsinki East Vaccine Research Clinic
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Jarvenpaa, Finland, 04400
- Järvenpää Vaccine Research Clinic
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Kokkola, Finland, 67100
- Kokkola Vaccine Research Clinic
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Kotka, Finland, 48600
- Kotka Clinic
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Kuopio, Finland, 70100
- Kuopio Vaccine Clinic
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Kuopio, Finland, 70211
- Kuopio Vaccine Research Clinic
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Lahti, Finland, 15140
- Lahti Vaccine Research Clinic
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Oulu, Finland, 90200
- Oulu Vaccine Research Clini
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Pori, Finland, 28100
- Pori Vaccine Research Clinic
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Seinajoki, Finland, 60100
- Seinajoki Clinic
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Tampere, Finland, 33100
- Tampere Vaccine Research Clinic
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Turku, Finland, 20520
- Turku Clinic
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Vantaa, Finland, 01600
- Vantaa West Vaccine Research Clinic
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West Vantaa, Finland, 01600
- West Vantaa Clinic
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Aalen Wasseralfingen, Germany, 73433
- Praxis Dr med Thilo Heising
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Berlin, Germany, 10315
- Praxis Dr med Ursula Hornlein
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Berlin, Germany, 10551
- Praxis Dr med Thomas Richter
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Berlin, Germany, 10559
- Praxis Dipl med Andreas Muhmer
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Berlin, Germany, 10627
- Praxis Dr med Mechthild Vocks-Hauck
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Berlin, Germany, 10999
- Praxis Dr med Klaus-Peter Falkowski
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Berlin, Germany, 12165
- Praxis Dr med Eva Brand
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Berlin, Germany, 12209
- Praxis Dr med Dorothea Budde
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Berlin, Germany, 12589
- Praxis Dr. med. Cornelia Busse
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Berlin, Germany, 12619
- Praxis Dipl. med. F. Temmler / Dipl. med. D. Wenzel
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Berlin, Germany, 12679
- Praxis Dr med Petra van Stiphout
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Berlin, Germany, 13347
- Praxis Dr Luise Schroeter
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Berlin, Germany, 13439
- "Praxis Dr med Dietrich Lasius"
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Berlin, Germany, 14052
- Praxis Dr. med. Petra Sandow
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Bindlach, Germany, 95463
- Praxis Dr Norbert Meister
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Binngen Rhein, Germany, 55411
- Praxis Dr med Thomas Tuschen
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Bobingen, Germany, 86399
- Praxis Dr. Elmar Dietmair
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Bochum, Germany, 44866
- Praxis Dr med Brigitta Becker
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Braunfels, Germany, 35619
- Praxis Karl-Heinz Blattel
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Bretten, Germany, 75015
- Praxis Dr. med. Roland Knecht
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Brunsbuettel, Germany, 25541
- Praxis Dr. med. Maria R. Holtorf
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Detmold, Germany, 32756
- Praxis Dr Klaus Helm
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Duesseldorf, Germany, 40223
- Praxis Joseph Zakarian
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Eschwege, Germany, 37269
- Praxis Dr med Hans-Henning Peters
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Essen, Germany, 45276
- Praxis Dr. med. Dirk Straub
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Flensburg, Germany, 24937
- Praxis Dr med Rainer Haase
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Flensburg, Germany, 24937
- Praxis Dr. med. Per Gildberg
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Flensburg, Germany, 24943
- Peaxis Dr H Outzen jun
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Frankenthal, Germany, 67227
- Praxis Dr Lothar MaurerJun
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Fulda, Germany, 36037
- Praxis Dr med Walter Otto
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Gau-Odernheim, Germany, 55239
- Praxis Dr med Hans-Joachim Buttner
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Gehrden, Germany, 30989
- Praxis Dr med Christian Kayser
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Gluecksburg, Germany, 24960
- Praxis Ute Jessat
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Grevenbroich, Germany, 41515
- Praxis Dr. med. Dubravka Pock-Lutz
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Hamburg, Germany, 22089
- Praxis Dr. med. Malte Klarczyk
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Hamburg, Germany, 22147
- Praxid Dr. med. Karl-Heinrich Hansen
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Hamburg, Germany, 22149
- Praxis Dr Anna Halat
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Hamburg, Germany, 22307
- Praxis Dr med Bernard Nast
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Hameln, Germany, 31785
- Praxis Dr med Jurgen Schwalbe
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Hille, Germany, 32479
- Praxis Dr med Hans-Heinrich Rohe
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Jena, Germany, 97745
- Praxis Dr Marlies Bolich
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Karlsruhe-Oberreut, Germany, 76189
- Praxis Peter Bosch
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Kleve-Materborn, Germany, 47533
- Praxis Dr Peter Andoko Soemantri
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Lauffen, Germany, 74348
- Praxis Dr. Michael Muehlschlegel
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Lobenstein, Germany, 07356
- Praxis Dr Sibylle Hetzinger
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Lohne, Germany, 32584
- Praxis Dipl med Dagmar Manegold-Randel
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Ludwigsburg, Germany, 71634
- Praxis Dr. Renate Lang
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Luneburg, Germany, 21339
- Praxis Dr med Julika Kelber
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Mainz, Germany, 55101
- Johannes Gutenberg-University
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Mainz, Germany, 55131
- Praxis Uwe Jakob
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Mannheim, Germany, 68167
- Praxis Dr med Falko Panzer
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Marbach a. N., Germany, 71672
- Praxis Dr med Volker Tempel
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Marktredwitz, Germany, 95615
- Praxis Dr. med. Herbert Kollaschinski
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Moenchengladbach, Germany, 41236
- Praxis Dr med Matthias Donner
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Moenchengladbach, Germany, 41236
- Praxis Ralph Koellges
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Muenchen, Germany, 81369
- Praxis Dr. med. Janina Joiko
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Munchen, Germany, 81377
- "Praxis Prof Dr med Stefan Walter Eber"
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Munchen, Germany, 81475
- Praxis Dr med Peter Dietl
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Munster / NRW, Germany, 48163
- Praxis Dr med Philip Fellner von Feldegg
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Neuhaus am Rennweg, Germany, 98724
- Praxis Dipl Med Ute Macholdt
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Neumuenster, Germany, 24534
- Praxis Dr Rossius
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Neumuenster, Germany, 24534
- Praxis Dr Sabine Maruschke
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Neumuenster, Germany, 24534
- Praxis Drs J und K Kandzora
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Niebuell, Germany, 25899
- Praxis Dr. med. S. Mohns-Petersen
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Niedernhausen, Germany, 65527
- Praxis Dr med Hartmut Scheele
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Porta Westfalica, Germany, 32457
- Praxis Dr med Stefan Noll
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Rendsburg, Germany, 24768
- Praxis Zlatka Zochev Donkov
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Schwabisch Hall, Germany, 74523
- Praxis Dr med Michael Vomstein
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Schwieberdingen, Germany, 71701
- "Praxis Dr med Gunther Knapp"
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Schönenberg, Germany, 66901
- Praxis Thomas Morandini
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Stadthagen, Germany, 31655
- Praxis Dr med Ulrich Soergel
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Stuttgart, Germany, 70469
- Praxis Dr Ulrich Pfletschinger
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Stuttgart, Germany, 70499
- Praxis Dr. med Manfred Heitz
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Stuttgart, Germany, 70619
- Praxis Dr. med Heidi B. John-Wagenmann
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Tauberbischofsheim, Germany, 97941
- Praxis Dr. med. Rolf Ebert
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Tettnang, Germany, 88069
- Praxis Dr med Karl-Eugen Mai
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Trier, Germany, 54290
- Praxis Dr med Klaus Kindler
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Tuttlingen, Germany, 78532
- Praxis Dr med Ralph Maier
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Viersen, Germany, 41751
- Praxis Dr med Ulrich Umpfenbach
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Weinstadt, Germany, 71384
- Praxis Dr med Volker Kemmerich
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Winsen, Germany, 29308
- Praxis Dr Per Bergmann
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Wurzen, Germany, 04808
- Praxis Dr med Steffi Bulst
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Milano, Italy, 20122
- Fondazione IRCCS Policlinico Mangiagalli e Regina Elena
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Novara, Italy, 28100
- Ospedale Maggiore della Carità
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children whose parents/legal guardians have given written informed consent prior to study entry: a) aged 6 to <72 months (Part I and II of the study; influenza seasons 2007/2008 and 2008/2009) b) aged 6 to <36 months (Part III of the study; influenza season 2009/2010)
- In good health as determined by: a) medical history, b) physical examination, c) clinical judgment of the investigator
Exclusion criteria:
- Administration of licensed vaccines (including H1N1sw vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol could be given after the active trial phase (i.e., 21 days after last vaccination) has been concluded.
- Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and participation in another clinical trial during the present study.
- Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable). The severity of the infectious disease occurred will be based on the investigator's judgment.
- Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start.
- Experience an axillary temperature equal to or greater than 37.8°C (rectal temperature equal to or greater than 38.3°C) within the 2 days before enrollment.
- Any serious disease in the opinion of the investigator including, for example: a) cancer, b) autoimmune disease (including rheumatoid arthritis under immunosuppressive therapy), c) insulin dependent diabetes mellitus, d) chronic pulmonary disease, asthma under inhalative therapy only is acceptable, e) acute or progressive hepatic disease, f) acute or progressive renal disease.
- Known or suspected impairment/alteration of immune function, for example, resulting from: a) receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy), b) receipt of immunostimulants, c) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and for the full length of the study, d) high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease).
- Bleeding diathesis.
- History of hypersensitivity to any component of the study medication or chemically related substances.
- History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component.
- Laboratory confirmed influenza disease.
- History of neurological disorder or seizures (febrile seizures allowed).
- Received any influenza vaccine.
- Major surgery planned during the study period.
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, e.g., planned travel or relocation of residence that would interfere with completion of study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TIV-adj
Adjuvanted trivalent inactivated subunit influenza vaccine
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Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
Other Names:
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Active Comparator: Flu-control
Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
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For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
Other Names:
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Sham Comparator: Non-flu Control
Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Time Frame: 7 days post-vaccination
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Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.
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7 days post-vaccination
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Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)
Time Frame: 3 weeks after 2nd vaccination
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Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy.
This primary endpoint is only for homologous strains.
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3 weeks after 2nd vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Time Frame: 7 days post-vaccination
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Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.
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7 days post-vaccination
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Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination
Time Frame: Study day 1 to Study day 181
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Number of subjects aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study
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Study day 1 to Study day 181
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Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)
Time Frame: 3 weeks after 2nd vaccination
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Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy. For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control. |
3 weeks after 2nd vaccination
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Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).
Time Frame: 3 weeks after 2nd vaccination
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Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy. For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control. |
3 weeks after 2nd vaccination
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Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Time Frame: 3 weeks after 2nd vaccination
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Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to <72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.
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3 weeks after 2nd vaccination
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Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Time Frame: 3 weeks after 2nd vaccination
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Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.
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3 weeks after 2nd vaccination
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Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.
Time Frame: 3 weeks after 2nd vaccination
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Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.
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3 weeks after 2nd vaccination
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Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.
Time Frame: 3 weeks after 2nd vaccination
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The number of events of Influenza like Illness reported by subjects aged 6 to <72 months was assessed for combined seasons 2007/08 and 2008/09
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3 weeks after 2nd vaccination
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Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50 and 181
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The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated. The criteria for evaluation is GMR >2.5 |
On study days 1, 29, 50 and 181
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Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50 and 181
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Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points. Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control |
On study days 1, 29, 50 and 181
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Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50, 181
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Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI.
The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.
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On study days 1, 29, 50, 181
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Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50, 181
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HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40. Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%. |
On study days 1, 29, 50, 181
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Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50 , 181
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Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay.
For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 and GMT-TIV-adj/GMT-Non Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.
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On study days 1, 29, 50 , 181
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Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50, 181
|
Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated. The criteria for evaluation is GMR >2.5 |
On study days 1, 29, 50, 181
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Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Time Frame: On study days 1, 29, 50, 181
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Hemagglutination Inhibition (HI) assay was used for the analysis. Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. |
On study days 1, 29, 50, 181
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Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Time Frame: On study days 1, 29, 50, 181
|
HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40. Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%. |
On study days 1, 29, 50, 181
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Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons
Time Frame: 7 days post-vaccination
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7 days post-vaccination
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Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child
Time Frame: 3 weeks after 2nd vaccination
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3 weeks after 2nd vaccination
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Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months
Time Frame: 3 weeks after 2nd vaccination
|
3 weeks after 2nd vaccination
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Novartis Vacccines and Diagnostics, Novartis
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V70P5
- Eudract number 2007-003786-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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