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

NCT ID: NCT00644059

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4902 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-08-31

Brief Summary

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.

Conditions

Influenza, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TIV-adj

Adjuvanted trivalent inactivated subunit influenza vaccine

Group Type: EXPERIMENTAL

Adjuvanted trivalent inactivated subunit influenza vaccine

Intervention Type: BIOLOGICAL

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.

Flu-control

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

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.

Non-flu Control

Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Group Type: SHAM_COMPARATOR

Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Intervention Type: BIOLOGICAL

1. Meningococcal vaccine: two IM injections

2. Tick-borne encephalitis vaccine: two IM injections

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

1. Meningococcal vaccine: two IM injections

2. Tick-borne encephalitis vaccine: two IM injections

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluad; 1) Agrippal; 2) Influsplit SSW; 1. Menjugate; 2. Encepur Children

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vacccines and Diagnostics

Role: STUDY_DIRECTOR

Novartis

Locations

East Vantaa Clinic

East Vaanta, , Finland

Espoo Vaccine Research Clinic

Espoo, , Finland

Helsinki South Vaccine Research Clinic

Helsinki, , Finland

Helsinki East Vaccine Research Clinic

Helsinki, , Finland

Jarvenpaa Vaccine Research Clinic

Järvenpää, , Finland

Kokkola Vaccine Research Clinic

Kokkola, , Finland

Kotka Clinic

Kotka, , Finland

Kuopio Vaccine Clinic

Kuopio, , Finland

Kuopio Vaccine Research Clinic

Kuopio, , Finland

Lahti vaccine research Clinic

Lahti, , Finland

Oulu Vaccine Research Clini

Oulu, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Seinajoki Clinic

Seinäjoki, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Turku Clinic

Turku, , Finland

Vantaa West Vaccine Research Clinic

Vantaa, , Finland

West Vantaa Clinic

West Vantaa, , Finland

Johannes Gutenberg-University

Mainz, Mainz, Germany

Praxis Dr med Thilo Heising

Aalen Wasseralfingen, , Germany

Praxis Dr med Ursula Hornlein

Berlin, , Germany

Praxis Dr med Thomas Richter

Berlin, , Germany

Praxis Dipl med Andreas Muhmer

Berlin, , Germany

Praxis Dr med Mechthild Vocks-Hauck

Berlin, , Germany

Praxis Dr med Klaus-Peter Falkowski

Berlin, , Germany

Praxis Dr med Eva Brand

Berlin, , Germany

Praxis Dr med Dorothea Budde

Berlin, , Germany

Praxis Dr. med. Cornelia Busse

Berlin, , Germany

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

Berlin, , Germany

Praxis Dr med Petra van Stiphout

Berlin, , Germany

Praxis Dr Luise Schroeter

Berlin, , Germany

"Praxis Dr med Dietrich Lasius"

Berlin, , Germany

Praxis Dr. med. Petra Sandow

Berlin, , Germany

Praxis Dr Norbert Meister

Bindlach, , Germany

Praxis Dr med Thomas Tuschen

Binngen Rhein, , Germany

Praxis Dr. Elmar Dietmair

Bobingen, , Germany

Praxis Dr med Brigitta Becker

Bochum, , Germany

Praxis Karl-Heinz Blattel

Braunfels, , Germany

Praxis Dr. med. Roland Knecht

Bretten, , Germany

Praxis Dr. med. Maria R. Holtorf

Brunsbüttel, , Germany

Praxis Dr Klaus Helm

Detmold, , Germany

Praxis Joseph Zakarian

Düsseldorf, , Germany

Praxis Dr med Hans-Henning Peters

Eschwege, , Germany

Praxis Dr. med. Dirk Straub

Essen, , Germany

Praxis Dr med Rainer Haase

Flensburg, , Germany

Praxis Dr. med. Per Gildberg

Flensburg, , Germany

Peaxis Dr H Outzen jun

Flensburg, , Germany

Praxis Dr Lothar MaurerJun

Frankenthal, , Germany

Praxis Dr med Walter Otto

Fulda, , Germany

Praxis Dr med Hans-Joachim Buttner

Gau-Odernheim, , Germany

Praxis Dr med Christian Kayser

Gehrden, , Germany

Praxis Ute Jessat

Glücksburg, , Germany

Praxis Dr. med. Dubravka Pock-Lutz

Grevenbroich, , Germany

Praxis Dr. med. Malte Klarczyk

Hamburg, , Germany

Praxid Dr. med. Karl-Heinrich Hansen

Hamburg, , Germany

Praxis Dr Anna Halat

Hamburg, , Germany

Praxis Dr med Bernard Nast

Hamburg, , Germany

Praxis Dr med Jurgen Schwalbe

Hamelin, , Germany

Praxis Dr med Hans-Heinrich Rohe

Hille, , Germany

Praxis Dr Marlies Bolich

Jena, , Germany

Praxis Peter Bosch

Karlsruhe-Oberreut, , Germany

Praxis Dr Peter Andoko Soemantri

Kleve-Materborn, , Germany

Praxis Dr. Michael Muehlschlegel

Lauffen am Neckar, , Germany

Praxis Dr Sibylle Hetzinger

Lobenstein, , Germany

Praxis Dipl med Dagmar Manegold-Randel

Löhne, , Germany

Praxis Dr. Renate Lang

Ludwigsburg, , Germany

Praxis Dr med Julika Kelber

Lüneburg, , Germany

Praxis Uwe Jakob

Mainz, , Germany

Praxis Dr med Falko Panzer

Mannheim, , Germany

Praxis Dr med Volker Tempel

Marbach A. N., , Germany

Praxis Dr. med. Herbert Kollaschinski

Marktredwitz, , Germany

Praxis Dr med Matthias Donner

Mönchengladbach, , Germany

Praxis Ralph Koellges

Mönchengladbach, , Germany

Praxis Dr med Philip Fellner von Feldegg

Munster / NRW, , Germany

Praxis Dr. med. Janina Joiko

München, , Germany

"Praxis Prof Dr med Stefan Walter Eber"

München, , Germany

Praxis Dr med Peter Dietl

München, , Germany

Praxis Dipl Med Ute Macholdt

Neuhaus am Rennweg, , Germany

Praxis Dr Rossius

Neumünster, , Germany

Praxis Dr Sabine Maruschke

Neumünster, , Germany

Praxis Drs J und K Kandzora

Neumünster, , Germany

Praxis Dr. med. S. Mohns-Petersen

Niebüll, , Germany

Praxis Dr med Hartmut Scheele

Niedernhausen, , Germany

Praxis Dr med Stefan Noll

Porta Westfalica, , Germany

Praxis Zlatka Zochev Donkov

Rendsburg, , Germany

Praxis Thomas Morandini

Schönenberg, , Germany

Praxis Dr med Michael Vomstein

Schwäbisch Hall, , Germany

"Praxis Dr med Gunther Knapp"

Schwieberdingen, , Germany

Praxis Dr med Ulrich Soergel

Stadthagen, , Germany

Praxis Dr Ulrich Pfletschinger

Stuttgart, , Germany

Praxis Dr. med Manfred Heitz

Stuttgart, , Germany

Praxis Dr. med Heidi B. John-Wagenmann

Stuttgart, , Germany

Praxis Dr. med. Rolf Ebert

Tauberbischofsheim, , Germany

Praxis Dr med Karl-Eugen Mai

Tettnang, , Germany

Praxis Dr med Klaus Kindler

Trier, , Germany

Praxis Dr med Ralph Maier

Tuttlingen, , Germany

Praxis Dr med Ulrich Umpfenbach

Viersen, , Germany

Praxis Dr med Volker Kemmerich

Weinstadt, , Germany

Praxis Dr Per Bergmann

Winsen, , Germany

Praxis Dr med Steffi Bulst

Wurzen, , Germany

Fondazione IRCCS Policlinico Mangiagalli e Regina Elena

Milan, , Italy

Ospedale Maggiore della Carita

Novara, , Italy

Countries

Finland; Germany; Italy

References

Vesikari T, Knuf M, Wutzler P, Karvonen A, Kieninger-Baum D, Schmitt HJ, Baehner F, Borkowski A, Tsai TF, Clemens R. Oil-in-water emulsion adjuvant with influenza vaccine in young children. N Engl J Med. 2011 Oct 13;365(15):1406-16. doi: 10.1056/NEJMoa1010331.

Reference Type: RESULT

PMID: 21995388 (View on PubMed)

Other Identifiers

Eudract number 2007-003786-41

Identifier Type: -

Identifier Source: secondary_id

V70P5

Identifier Type: -

Identifier Source: org_study_id

NCT01015885

Identifier Type: -

Identifier Source: nct_alias