This study will evaluate the efficacy, safety and immunogenicity of one or two 0. 25 mL or
0. 5 mL intramuscular injections of an adjuvanted influenza vaccine compared with
non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to <72 months of
age.
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.
East Vantaa Clinic, East Vaanta 01300, Finland
Espoo Vaccine Research Clinic, Espoo 02100, Finland
Helsinki East Vaccine Research Clinic, Helsinki 00930, Finland
Helsinki South Vaccine Research Clinic, Helsinki 00100, Finland
Jarvenpaa Vaccine Research Clinic, Jarvenpaa 04400, Finland
Kokkola Vaccine Research Clinic, Kokkola 67100, Finland
Kotka Clinic, Kotka 48600, Finland
Kuopio Vaccine Clinic, Kuopio 70100, Finland
Kuopio Vaccine Research Clinic, Kuopio 70211, Finland
Lahti vaccine research Clinic, Lahti 15140, Finland
Oulu Vaccine Research Clini, Oulu 90200, Finland
Pori Vaccine Research Clinic, Pori 28100, Finland
Seinajoki Clinic, Seinajoki 60100, Finland
Tampere Vaccine Research Clinic, Tampere 33100, Finland
Turku Clinic, Turku 20520, Finland
Vantaa West Vaccine Research Clinic, Vantaa 01600, Finland
West Vantaa Clinic, West Vantaa 01600, Finland
Praxis Dr med Thilo Heising, Aalen Wasseralfingen 73433, Germany
"Praxis Dr med Dietrich Lasius", Berlin 13439, Germany
Praxis Dipl med Andreas Muhmer, Berlin 10559, Germany
Praxis Dipl. med. F. Temmler / Dipl. med. D. Wenzel, Berlin 12619, Germany
Praxis Dr Luise Schroeter, Berlin 13347, Germany
Praxis Dr med Dorothea Budde, Berlin 12209, Germany
Praxis Dr med Eva Brand, Berlin 12165, Germany
Praxis Dr med Klaus-Peter Falkowski, Berlin 10999, Germany
Praxis Dr med Mechthild Vocks-Hauck, Berlin 10627, Germany
Praxis Dr med Petra van Stiphout, Berlin 12679, Germany
Praxis Dr med Thomas Richter, Berlin 10551, Germany
Praxis Dr med Ursula Hornlein, Berlin 10315, Germany
Praxis Dr. med. Cornelia Busse, Berlin 12589, Germany
Praxis Dr. med. Petra Sandow, Berlin 14052, Germany
Praxis Dr Norbert Meister, Bindlach 95463, Germany
Praxis Dr med Thomas Tuschen, Binngen Rhein 55411, Germany
Praxis Dr. Elmar Dietmair, Bobingen 86399, Germany
Praxis Dr med Brigitta Becker, Bochum 44866, Germany
Praxis Karl-Heinz Blattel, Braunfels 35619, Germany
Praxis Dr. med. Roland Knecht, Bretten 75015, Germany
Praxis Dr. med. Maria R. Holtorf, Brunsbuettel 25541, Germany
Praxis Dr Klaus Helm, Detmold 32756, Germany
Praxis Joseph Zakarian, Duesseldorf 40223, Germany
Praxis Dr med Hans-Henning Peters, Eschwege 37269, Germany
Praxis Dr. med. Dirk Straub, Essen 45276, Germany
Peaxis Dr H Outzen jun, Flensburg 24943, Germany
Praxis Dr med Rainer Haase, Flensburg 24937, Germany
Praxis Dr. med. Per Gildberg, Flensburg 24937, Germany
Praxis Dr Lothar MaurerJun, Frankenthal 67227, Germany
Praxis Dr med Walter Otto, Fulda 36037, Germany
Praxis Dr med Hans-Joachim Buttner, Gau-Odernheim 55239, Germany
Praxis Dr med Christian Kayser, Gehrden 30989, Germany
Praxis Ute Jessat, Gluecksburg 24960, Germany
Praxis Dr. med. Dubravka Pock-Lutz, Grevenbroich 41515, Germany
Praxid Dr. med. Karl-Heinrich Hansen, Hamburg 22147, Germany
Praxis Dr Anna Halat, Hamburg 22149, Germany
Praxis Dr med Bernard Nast, Hamburg 22307, Germany
Praxis Dr. med. Malte Klarczyk, Hamburg 22089, Germany
Praxis Dr med Jurgen Schwalbe, Hameln 31785, Germany
Praxis Dr med Hans-Heinrich Rohe, Hille 32479, Germany
Praxis Dr Marlies Bolich, Jena 97745, Germany
Praxis Peter Bosch, Karlsruhe-Oberreut 76189, Germany
Praxis Dr Peter Andoko Soemantri, Kleve-Materborn 47533, Germany
Praxis Dr. Michael Muehlschlegel, Lauffen 74348, Germany
Praxis Dr Sibylle Hetzinger, Lobenstein 07356, Germany
Praxis Dipl med Dagmar Manegold-Randel, Lohne 32584, Germany
Praxis Dr. Renate Lang, Ludwigsburg 71634, Germany
Praxis Dr med Julika Kelber, Luneburg 21339, Germany
Johannes Gutenberg-University, Mainz 55101, Germany
Praxis Uwe Jakob, Mainz 55131, Germany
Praxis Dr med Falko Panzer, Mannheim 68167, Germany
Praxis Dr med Volker Tempel, Marbach a. N. 71672, Germany
Praxis Dr. med. Herbert Kollaschinski, Marktredwitz 95615, Germany
Praxis Dr med Matthias Donner, Moenchengladbach 41236, Germany
Praxis Ralph Koellges, Moenchengladbach 41236, Germany
Praxis Dr. med. Janina Joiko, Muenchen 81369, Germany
"Praxis Prof Dr med Stefan Walter Eber", Munchen 81377, Germany
Praxis Dr med Peter Dietl, Munchen 81475, Germany
Praxis Dr med Philip Fellner von Feldegg, Munster / NRW 48163, Germany
Praxis Dipl Med Ute Macholdt, Neuhaus am Rennweg 98724, Germany
Praxis Dr Rossius, Neumuenster 24534, Germany
Praxis Dr Sabine Maruschke, Neumuenster 24534, Germany
Praxis Drs J und K Kandzora, Neumuenster 24534, Germany
Praxis Dr. med. S. Mohns-Petersen, Niebuell 25899, Germany
Praxis Dr med Hartmut Scheele, Niedernhausen 65527, Germany
Praxis Dr med Stefan Noll, Porta Westfalica 32457, Germany
Praxis Zlatka Zochev Donkov, Rendsburg 24768, Germany
Praxis Dr med Michael Vomstein, Schwabisch Hall 74523, Germany
"Praxis Dr med Gunther Knapp", Schwieberdingen 71701, Germany
Praxis Thomas Morandini, Schönenberg 66901, Germany
Praxis Dr med Ulrich Soergel, Stadthagen 31655, Germany
Praxis Dr Ulrich Pfletschinger, Stuttgart 70469, Germany
Praxis Dr. med Heidi B. John-Wagenmann, Stuttgart 70619, Germany
Praxis Dr. med Manfred Heitz, Stuttgart 70499, Germany
Praxis Dr. med. Rolf Ebert, Tauberbischofsheim 97941, Germany
Praxis Dr med Karl-Eugen Mai, Tettnang 88069, Germany
Praxis Dr med Klaus Kindler, Trier 54290, Germany
Praxis Dr med Ralph Maier, Tuttlingen 78532, Germany
Praxis Dr med Ulrich Umpfenbach, Viersen 41751, Germany
Praxis Dr med Volker Kemmerich, Weinstadt 71384, Germany
Praxis Dr Per Bergmann, Winsen 29308, Germany
Praxis Dr med Steffi Bulst, Wurzen 04808, Germany
Fondazione IRCCS Policlinico Mangiagalli e Regina Elena, Milano 20122, Italy
Ospedale Maggiore della Carita, Novara 28100, Italy
