Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines

PHASE3CompletedINTERVENTIONAL
Enrollment

4,902

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

August 31, 2010

Conditions
Influenza, Human
Interventions
BIOLOGICAL

Adjuvanted trivalent inactivated subunit influenza vaccine

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.

BIOLOGICAL

Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

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.

BIOLOGICAL

Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

"1. Meningococcal vaccine: two IM injections~2. Tick-borne encephalitis vaccine: two IM injections"

Trial Locations (101)

10315

Praxis Dr med Ursula Hornlein, Berlin

10551

Praxis Dr med Thomas Richter, Berlin

10559

Praxis Dipl med Andreas Muhmer, Berlin

10627

Praxis Dr med Mechthild Vocks-Hauck, Berlin

10999

Praxis Dr med Klaus-Peter Falkowski, Berlin

12165

Praxis Dr med Eva Brand, Berlin

12209

Praxis Dr med Dorothea Budde, Berlin

12589

Praxis Dr. med. Cornelia Busse, Berlin

12619

Praxis Dipl. med. F. Temmler / Dipl. med. D. Wenzel, Berlin

12679

Praxis Dr med Petra van Stiphout, Berlin

13347

Praxis Dr Luise Schroeter, Berlin

13439

"Praxis Dr med Dietrich Lasius", Berlin

14052

Praxis Dr. med. Petra Sandow, Berlin

15140

Lahti vaccine research Clinic, Lahti

20122

Fondazione IRCCS Policlinico Mangiagalli e Regina Elena, Milan

20520

Turku Clinic, Turku

21339

Praxis Dr med Julika Kelber, Lüneburg

22089

Praxis Dr. med. Malte Klarczyk, Hamburg

22147

Praxid Dr. med. Karl-Heinrich Hansen, Hamburg

22149

Praxis Dr Anna Halat, Hamburg

22307

Praxis Dr med Bernard Nast, Hamburg

24534

Praxis Dr Rossius, Neumünster

Praxis Dr Sabine Maruschke, Neumünster

Praxis Drs J und K Kandzora, Neumünster

24768

Praxis Zlatka Zochev Donkov, Rendsburg

24937

Praxis Dr med Rainer Haase, Flensburg

Praxis Dr. med. Per Gildberg, Flensburg

24943

Peaxis Dr H Outzen jun, Flensburg

24960

Praxis Ute Jessat, Glücksburg

25541

Praxis Dr. med. Maria R. Holtorf, Brunsbüttel

25899

Praxis Dr. med. S. Mohns-Petersen, Niebüll

28100

Pori Vaccine Research Clinic, Pori

Ospedale Maggiore della Carita, Novara

29308

Praxis Dr Per Bergmann, Winsen

30989

Praxis Dr med Christian Kayser, Gehrden

31655

Praxis Dr med Ulrich Soergel, Stadthagen

31785

Praxis Dr med Jurgen Schwalbe, Hamelin

32457

Praxis Dr med Stefan Noll, Porta Westfalica

32479

Praxis Dr med Hans-Heinrich Rohe, Hille

32584

Praxis Dipl med Dagmar Manegold-Randel, Löhne

32756

Praxis Dr Klaus Helm, Detmold

33100

Tampere Vaccine Research Clinic, Tampere

35619

Praxis Karl-Heinz Blattel, Braunfels

36037

Praxis Dr med Walter Otto, Fulda

37269

Praxis Dr med Hans-Henning Peters, Eschwege

40223

Praxis Joseph Zakarian, Düsseldorf

41236

Praxis Dr med Matthias Donner, Mönchengladbach

Praxis Ralph Koellges, Mönchengladbach

41515

Praxis Dr. med. Dubravka Pock-Lutz, Grevenbroich

41751

Praxis Dr med Ulrich Umpfenbach, Viersen

44866

Praxis Dr med Brigitta Becker, Bochum

45276

Praxis Dr. med. Dirk Straub, Essen

47533

Praxis Dr Peter Andoko Soemantri, Kleve-Materborn

48163

Praxis Dr med Philip Fellner von Feldegg, Munster / NRW

48600

Kotka Clinic, Kotka

54290

Praxis Dr med Klaus Kindler, Trier

55101

Johannes Gutenberg-University, Mainz

55131

Praxis Uwe Jakob, Mainz

55239

Praxis Dr med Hans-Joachim Buttner, Gau-Odernheim

55411

Praxis Dr med Thomas Tuschen, Binngen Rhein

60100

Seinajoki Clinic, Seinäjoki

65527

Praxis Dr med Hartmut Scheele, Niedernhausen

66901

Praxis Thomas Morandini, Schönenberg

67100

Kokkola Vaccine Research Clinic, Kokkola

67227

Praxis Dr Lothar MaurerJun, Frankenthal

68167

Praxis Dr med Falko Panzer, Mannheim

70100

Kuopio Vaccine Clinic, Kuopio

70211

Kuopio Vaccine Research Clinic, Kuopio

70469

Praxis Dr Ulrich Pfletschinger, Stuttgart

70499

Praxis Dr. med Manfred Heitz, Stuttgart

70619

Praxis Dr. med Heidi B. John-Wagenmann, Stuttgart

71384

Praxis Dr med Volker Kemmerich, Weinstadt

71634

Praxis Dr. Renate Lang, Ludwigsburg

71672

Praxis Dr med Volker Tempel, Marbach A. N.

71701

"Praxis Dr med Gunther Knapp", Schwieberdingen

73433

Praxis Dr med Thilo Heising, Aalen Wasseralfingen

74348

Praxis Dr. Michael Muehlschlegel, Lauffen am Neckar

74523

Praxis Dr med Michael Vomstein, Schwäbisch Hall

75015

Praxis Dr. med. Roland Knecht, Bretten

76189

Praxis Peter Bosch, Karlsruhe-Oberreut

78532

Praxis Dr med Ralph Maier, Tuttlingen

81369

Praxis Dr. med. Janina Joiko, München

81377

"Praxis Prof Dr med Stefan Walter Eber", München

81475

Praxis Dr med Peter Dietl, München

86399

Praxis Dr. Elmar Dietmair, Bobingen

88069

Praxis Dr med Karl-Eugen Mai, Tettnang

90200

Oulu Vaccine Research Clini, Oulu

95463

Praxis Dr Norbert Meister, Bindlach

95615

Praxis Dr. med. Herbert Kollaschinski, Marktredwitz

97745

Praxis Dr Marlies Bolich, Jena

97941

Praxis Dr. med. Rolf Ebert, Tauberbischofsheim

98724

Praxis Dipl Med Ute Macholdt, Neuhaus am Rennweg

01300

East Vantaa Clinic, East Vaanta

02100

Espoo Vaccine Research Clinic, Espoo

00100

Helsinki South Vaccine Research Clinic, Helsinki

00930

Helsinki East Vaccine Research Clinic, Helsinki

04400

Jarvenpaa Vaccine Research Clinic, Järvenpää

01600

Vantaa West Vaccine Research Clinic, Vantaa

West Vantaa Clinic, West Vantaa

07356

Praxis Dr Sibylle Hetzinger, Lobenstein

04808

Praxis Dr med Steffi Bulst, Wurzen

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY

NCT00644059 - Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines | Biotech Hunter | Biotech Hunter