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

NCT00644059 | Completed Phase 3 Results DMC

• 2 other identifiers: V70P5Eudract number 2007-003786-41
• Study Type: interventional
• Target: 4,902
• Locations: 3 countries
• Sites: 101

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

Keywords

Influenza; vaccine; children

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 days post-vaccination

• 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)

  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.

  3 weeks after 2nd vaccination

Secondary Outcomes (19)

• Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination

  7 days post-vaccination

• Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination

  Study day 1 to Study day 181

• 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)

  3 weeks after 2nd vaccination

• 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).

  3 weeks after 2nd vaccination

• 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

  3 weeks after 2nd vaccination

Study Arms (3)

TIV-adj

EXPERIMENTAL

Adjuvanted trivalent inactivated subunit influenza vaccine

Biological: Adjuvanted trivalent inactivated subunit influenza vaccine

Flu-control

ACTIVE COMPARATOR

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

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

Non-flu Control

SHAM COMPARATOR

Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Interventions

Adjuvanted trivalent inactivated subunit influenza vaccine 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.

Also known as: Fluad

TIV-adj

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

Also known as: 1) Agrippal, 2) Influsplit SSW

Flu-control

Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine BIOLOGICAL

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

Also known as: 1. Menjugate, 2. Encepur Children

Non-flu Control

Eligibility Criteria

• Age: 6 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (101)

East Vantaa Clinic

East Vaanta, 01300, Finland

Location

Espoo Vaccine Research Clinic

Espoo, 02100, Finland

Location

Helsinki South Vaccine Research Clinic

Helsinki, 00100, Finland

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

Kotka Clinic

Kotka, 48600, Finland

Location

Kuopio Vaccine Clinic

Kuopio, 70100, Finland

Location

Kuopio Vaccine Research Clinic

Kuopio, 70211, Finland

Location

Lahti vaccine research Clinic

Lahti, 15140, Finland

Location

Oulu Vaccine Research Clini

Oulu, 90200, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Seinajoki Clinic

Seinäjoki, 60100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Turku Clinic

Turku, 20520, Finland

Location

Vantaa West Vaccine Research Clinic

Vantaa, 01600, Finland

Location

West Vantaa Clinic

West Vantaa, 01600, Finland

Location

Johannes Gutenberg-University

Mainz, Mainz, 55101, Germany

Location

Praxis Dr med Thilo Heising

Aalen Wasseralfingen, 73433, Germany

Location

Praxis Dr med Ursula Hornlein

Berlin, 10315, Germany

Location

Praxis Dr med Thomas Richter

Berlin, 10551, Germany

Location

Praxis Dipl med Andreas Muhmer

Berlin, 10559, Germany

Location

Praxis Dr med Mechthild Vocks-Hauck

Berlin, 10627, Germany

Location

Praxis Dr med Klaus-Peter Falkowski

Berlin, 10999, Germany

Location

Praxis Dr med Eva Brand

Berlin, 12165, Germany

Location

Praxis Dr med Dorothea Budde

Berlin, 12209, Germany

Location

Praxis Dr. med. Cornelia Busse

Berlin, 12589, Germany

Location

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

Berlin, 12619, Germany

Location

Praxis Dr med Petra van Stiphout

Berlin, 12679, Germany

Location

Praxis Dr Luise Schroeter

Berlin, 13347, Germany

Location

"Praxis Dr med Dietrich Lasius"

Berlin, 13439, Germany

Location

Praxis Dr. med. Petra Sandow

Berlin, 14052, Germany

Location

Praxis Dr Norbert Meister

Bindlach, 95463, Germany

Location

Praxis Dr med Thomas Tuschen

Binngen Rhein, 55411, Germany

Location

Praxis Dr. Elmar Dietmair

Bobingen, 86399, Germany

Location

Praxis Dr med Brigitta Becker

Bochum, 44866, Germany

Location

Praxis Karl-Heinz Blattel

Braunfels, 35619, Germany

Location

Praxis Dr. med. Roland Knecht

Bretten, 75015, Germany

Location

Praxis Dr. med. Maria R. Holtorf

Brunsbüttel, 25541, Germany

Location

Praxis Dr Klaus Helm

Detmold, 32756, Germany

Location

Praxis Joseph Zakarian

Düsseldorf, 40223, Germany

Location

Praxis Dr med Hans-Henning Peters

Eschwege, 37269, Germany

Location

Praxis Dr. med. Dirk Straub

Essen, 45276, Germany

Location

Praxis Dr med Rainer Haase

Flensburg, 24937, Germany

Location

Praxis Dr. med. Per Gildberg

Flensburg, 24937, Germany

Location

Peaxis Dr H Outzen jun

Flensburg, 24943, Germany

Location

Praxis Dr Lothar MaurerJun

Frankenthal, 67227, Germany

Location

Praxis Dr med Walter Otto

Fulda, 36037, Germany

Location

Praxis Dr med Hans-Joachim Buttner

Gau-Odernheim, 55239, Germany

Location

Praxis Dr med Christian Kayser

Gehrden, 30989, Germany

Location

Praxis Ute Jessat

Glücksburg, 24960, Germany

Location

Praxis Dr. med. Dubravka Pock-Lutz

Grevenbroich, 41515, Germany

Location

Praxis Dr. med. Malte Klarczyk

Hamburg, 22089, Germany

Location

Praxid Dr. med. Karl-Heinrich Hansen

Hamburg, 22147, Germany

Location

Praxis Dr Anna Halat

Hamburg, 22149, Germany

Location

Praxis Dr med Bernard Nast

Hamburg, 22307, Germany

Location

Praxis Dr med Jurgen Schwalbe

Hamelin, 31785, Germany

Location

Praxis Dr med Hans-Heinrich Rohe

Hille, 32479, Germany

Location

Praxis Dr Marlies Bolich

Jena, 97745, Germany

Location

Praxis Peter Bosch

Karlsruhe-Oberreut, 76189, Germany

Location

Praxis Dr Peter Andoko Soemantri

Kleve-Materborn, 47533, Germany

Location

Praxis Dr. Michael Muehlschlegel

Lauffen am Neckar, 74348, Germany

Location

Praxis Dr Sibylle Hetzinger

Lobenstein, 07356, Germany

Location

Praxis Dipl med Dagmar Manegold-Randel

Löhne, 32584, Germany

Location

Praxis Dr. Renate Lang

Ludwigsburg, 71634, Germany

Location

Praxis Dr med Julika Kelber

Lüneburg, 21339, Germany

Location

Praxis Uwe Jakob

Mainz, 55131, Germany

Location

Praxis Dr med Falko Panzer

Mannheim, 68167, Germany

Location

Praxis Dr med Volker Tempel

Marbach A. N., 71672, Germany

Location

Praxis Dr. med. Herbert Kollaschinski

Marktredwitz, 95615, Germany

Location

Praxis Dr med Matthias Donner

Mönchengladbach, 41236, Germany

Location

Praxis Ralph Koellges

Mönchengladbach, 41236, Germany

Location

Praxis Dr med Philip Fellner von Feldegg

Munster / NRW, 48163, Germany

Location

Praxis Dr. med. Janina Joiko

München, 81369, Germany

Location

"Praxis Prof Dr med Stefan Walter Eber"

München, 81377, Germany

Location

Praxis Dr med Peter Dietl

München, 81475, Germany

Location

Praxis Dipl Med Ute Macholdt

Neuhaus am Rennweg, 98724, Germany

Location

Praxis Dr Rossius

Neumünster, 24534, Germany

Location

Praxis Dr Sabine Maruschke

Neumünster, 24534, Germany

Location

Praxis Drs J und K Kandzora

Neumünster, 24534, Germany

Location

Praxis Dr. med. S. Mohns-Petersen

Niebüll, 25899, Germany

Location

Praxis Dr med Hartmut Scheele

Niedernhausen, 65527, Germany

Location

Praxis Dr med Stefan Noll

Porta Westfalica, 32457, Germany

Location

Praxis Zlatka Zochev Donkov

Rendsburg, 24768, Germany

Location

Praxis Thomas Morandini

Schönenberg, 66901, Germany

Location

Praxis Dr med Michael Vomstein

Schwäbisch Hall, 74523, Germany

Location

"Praxis Dr med Gunther Knapp"

Schwieberdingen, 71701, Germany

Location

Praxis Dr med Ulrich Soergel

Stadthagen, 31655, Germany

Location

Praxis Dr Ulrich Pfletschinger

Stuttgart, 70469, Germany

Location

Praxis Dr. med Manfred Heitz

Stuttgart, 70499, Germany

Location

Praxis Dr. med Heidi B. John-Wagenmann

Stuttgart, 70619, Germany

Location

Praxis Dr. med. Rolf Ebert

Tauberbischofsheim, 97941, Germany

Location

Praxis Dr med Karl-Eugen Mai

Tettnang, 88069, Germany

Location

Praxis Dr med Klaus Kindler

Trier, 54290, Germany

Location

Praxis Dr med Ralph Maier

Tuttlingen, 78532, Germany

Location

Praxis Dr med Ulrich Umpfenbach

Viersen, 41751, Germany

Location

Praxis Dr med Volker Kemmerich

Weinstadt, 71384, Germany

Location

Praxis Dr Per Bergmann

Winsen, 29308, Germany

Location

Praxis Dr med Steffi Bulst

Wurzen, 04808, Germany

Location

Fondazione IRCCS Policlinico Mangiagalli e Regina Elena

Milan, 20122, Italy

Location

Ospedale Maggiore della Carita

Novara, 28100, Italy

Location

Related Publications (1)

• 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.

  PMID: 21995388 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

fluad vaccine; serogroup C meningococcal conjugate vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vacccines and Diagnostics

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 18, 2015
• Results First Posted: October 15, 2014

Record last verified: 2015-08

Locations

DE (82); IT (2); FI (17)