AzTrials
AzTrials

Influenza, HumanPhase 3NCT00644059

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

A Phase 3 study testing Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine and Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine in people with Influenza, Human, run by Novartis at 101 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 71 monthsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine and Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,902 participants
Where
101 sitesin 3 countries
Study dates
Nov 2007to Aug 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 71 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

101 sites in 3 countries.

101 sites in 3 countries

Germany82 sites

  • Praxis Dr med Thilo Heising

    Aalen Wasseralfingen, 73433

  • Praxis Dr med Ursula Hornlein

    Berlin, 10315

  • Praxis Dr med Thomas Richter

    Berlin, 10551

  • Praxis Dipl med Andreas Muhmer

    Berlin, 10559

  • Praxis Dr med Mechthild Vocks-Hauck

    Berlin, 10627

  • Praxis Dr med Klaus-Peter Falkowski

    Berlin, 10999

  • Praxis Dr med Eva Brand

    Berlin, 12165

  • Praxis Dr med Dorothea Budde

    Berlin, 12209

  • Praxis Dr. med. Cornelia Busse

    Berlin, 12589

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

    Berlin, 12619

  • Praxis Dr med Petra van Stiphout

    Berlin, 12679

  • Praxis Dr Luise Schroeter

    Berlin, 13347

  • "Praxis Dr med Dietrich Lasius"

    Berlin, 13439

  • Praxis Dr. med. Petra Sandow

    Berlin, 14052

  • Praxis Dr Norbert Meister

    Bindlach, 95463

  • Praxis Dr med Thomas Tuschen

    Binngen Rhein, 55411

  • Praxis Dr. Elmar Dietmair

    Bobingen, 86399

  • Praxis Dr med Brigitta Becker

    Bochum, 44866

  • Praxis Karl-Heinz Blattel

    Braunfels, 35619

  • Praxis Dr. med. Roland Knecht

    Bretten, 75015

  • Praxis Dr. med. Maria R. Holtorf

    Brunsbüttel, 25541

  • Praxis Dr Klaus Helm

    Detmold, 32756

  • Praxis Joseph Zakarian

    Düsseldorf, 40223

  • Praxis Dr med Hans-Henning Peters

    Eschwege, 37269

  • Praxis Dr. med. Dirk Straub

    Essen, 45276

  • Praxis Dr med Rainer Haase

    Flensburg, 24937

  • Praxis Dr. med. Per Gildberg

    Flensburg, 24937

  • Peaxis Dr H Outzen jun

    Flensburg, 24943

  • Praxis Dr Lothar MaurerJun

    Frankenthal, 67227

  • Praxis Dr med Walter Otto

    Fulda, 36037

  • Praxis Dr med Hans-Joachim Buttner

    Gau-Odernheim, 55239

  • Praxis Dr med Christian Kayser

    Gehrden, 30989

  • Praxis Ute Jessat

    Glücksburg, 24960

  • Praxis Dr. med. Dubravka Pock-Lutz

    Grevenbroich, 41515

  • Praxis Dr. med. Malte Klarczyk

    Hamburg, 22089

  • Praxid Dr. med. Karl-Heinrich Hansen

    Hamburg, 22147

  • Praxis Dr Anna Halat

    Hamburg, 22149

  • Praxis Dr med Bernard Nast

    Hamburg, 22307

  • Praxis Dr med Jurgen Schwalbe

    Hamelin, 31785

  • Praxis Dr med Hans-Heinrich Rohe

    Hille, 32479

  • Praxis Dr Marlies Bolich

    Jena, 97745

  • Praxis Peter Bosch

    Karlsruhe-Oberreut, 76189

  • Praxis Dr Peter Andoko Soemantri

    Kleve-Materborn, 47533

  • Praxis Dr. Michael Muehlschlegel

    Lauffen am Neckar, 74348

  • Praxis Dr Sibylle Hetzinger

    Lobenstein, 07356

  • Praxis Dipl med Dagmar Manegold-Randel

    Löhne, 32584

  • Praxis Dr. Renate Lang

    Ludwigsburg, 71634

  • Praxis Dr med Julika Kelber

    Lüneburg, 21339

  • Johannes Gutenberg-University

    Mainz, Mainz, 55101

  • Praxis Uwe Jakob

    Mainz, 55131

  • Praxis Dr med Falko Panzer

    Mannheim, 68167

  • Praxis Dr med Volker Tempel

    Marbach A. N., 71672

  • Praxis Dr. med. Herbert Kollaschinski

    Marktredwitz, 95615

  • Praxis Dr med Matthias Donner

    Mönchengladbach, 41236

  • Praxis Ralph Koellges

    Mönchengladbach, 41236

  • Praxis Dr. med. Janina Joiko

    München, 81369

  • "Praxis Prof Dr med Stefan Walter Eber"

    München, 81377

  • Praxis Dr med Peter Dietl

    München, 81475

  • Praxis Dr med Philip Fellner von Feldegg

    Munster / NRW, 48163

  • Praxis Dipl Med Ute Macholdt

    Neuhaus am Rennweg, 98724

  • Praxis Dr Rossius

    Neumünster, 24534

  • Praxis Dr Sabine Maruschke

    Neumünster, 24534

  • Praxis Drs J und K Kandzora

    Neumünster, 24534

  • Praxis Dr. med. S. Mohns-Petersen

    Niebüll, 25899

  • Praxis Dr med Hartmut Scheele

    Niedernhausen, 65527

  • Praxis Dr med Stefan Noll

    Porta Westfalica, 32457

  • Praxis Zlatka Zochev Donkov

    Rendsburg, 24768

  • Praxis Thomas Morandini

    Schönenberg, 66901

  • Praxis Dr med Michael Vomstein

    Schwäbisch Hall, 74523

  • "Praxis Dr med Gunther Knapp"

    Schwieberdingen, 71701

  • Praxis Dr med Ulrich Soergel

    Stadthagen, 31655

  • Praxis Dr Ulrich Pfletschinger

    Stuttgart, 70469

  • Praxis Dr. med Manfred Heitz

    Stuttgart, 70499

  • Praxis Dr. med Heidi B. John-Wagenmann

    Stuttgart, 70619

  • Praxis Dr. med. Rolf Ebert

    Tauberbischofsheim, 97941

  • Praxis Dr med Karl-Eugen Mai

    Tettnang, 88069

  • Praxis Dr med Klaus Kindler

    Trier, 54290

  • Praxis Dr med Ralph Maier

    Tuttlingen, 78532

  • Praxis Dr med Ulrich Umpfenbach

    Viersen, 41751

  • Praxis Dr med Volker Kemmerich

    Weinstadt, 71384

  • Praxis Dr Per Bergmann

    Winsen, 29308

  • Praxis Dr med Steffi Bulst

    Wurzen, 04808

Other trials in Germany

Finland17 sites

  • East Vantaa Clinic

    East Vaanta, 01300

  • Espoo Vaccine Research Clinic

    Espoo, 02100

  • Helsinki South Vaccine Research Clinic

    Helsinki, 00100

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Jarvenpaa Vaccine Research Clinic

    Jarvenpaa, 04400

  • Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • Kotka Clinic

    Kotka, 48600

  • Kuopio Vaccine Clinic

    Kuopio, 70100

  • Kuopio Vaccine Research Clinic

    Kuopio, 70211

  • Lahti vaccine research Clinic

    Lahti, 15140

  • Oulu Vaccine Research Clini

    Oulu, 90200

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinajoki Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Turku Clinic

    Turku, 20520

  • Vantaa West Vaccine Research Clinic

    Vantaa, 01600

  • West Vantaa Clinic

    West Vantaa, 01600

Other trials in Finland

Italy2 sites

  • Fondazione IRCCS Policlinico Mangiagalli e Regina Elena

    Milan, 20122

  • Ospedale Maggiore della Carita

    Novara, 28100

Other trials in Italy

About this study

Official title: 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

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.

Being tested
Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine, Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Keywords
Influenza, vaccine, children
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvanted trivalent inactivated subunit influenza vaccineBiological

    Also called Fluad

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

    Also called 1) Agrippal, 2) Influsplit SSW

    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.

  • Meningococcal C conjugate vaccine or tick-borne encephalitis vaccineBiological

    Also called 1. Menjugate, 2. Encepur Children

    1. Meningococcal vaccine: two IM injections
    2. Tick-borne encephalitis vaccine: two IM injections
Study groups in NCT00644059
Study groupRoleWhat they receive
TIV-adjExperimentalAdjuvanted trivalent inactivated subunit influenza vaccine
Receives: Biological: Adjuvanted trivalent inactivated subunit influenza vaccine
Flu-controlActive comparatorNon-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Receives: Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Non-flu ControlSham comparatorNovartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Receives: Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 days post-vaccination

  2. 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.

    Measured: 3 weeks after 2nd vaccination

Secondary outcomes (19)

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

    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.

    Measured: 7 days post-vaccination

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

    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

    Measured: Study day 1 to Study day 181

  3. 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)

    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.

    Measured: 3 weeks after 2nd vaccination

  4. 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).

    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.

    Measured: 3 weeks after 2nd vaccination

  5. 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

    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.

    Measured: 3 weeks after 2nd vaccination

  6. 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

    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.

    Measured: 3 weeks after 2nd vaccination

  7. 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.

    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.

    Measured: 3 weeks after 2nd vaccination

  8. Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.

    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

    Measured: 3 weeks after 2nd vaccination

  9. 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)

    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

    Measured: On study days 1, 29, 50 and 181

  10. 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)

    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

    Measured: On study days 1, 29, 50 and 181

  11. 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)

    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%.

    Measured: On study days 1, 29, 50, 181

  12. Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)

    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%.

    Measured: On study days 1, 29, 50, 181

  13. 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)

    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.

    Measured: On study days 1, 29, 50 , 181

  14. 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)

    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

    Measured: On study days 1, 29, 50, 181

  15. 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

    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%.

    Measured: On study days 1, 29, 50, 181

  16. 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)

    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%.

    Measured: On study days 1, 29, 50, 181

  17. 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

    Measured: 7 days post-vaccination

  18. 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

    Measured: 3 weeks after 2nd vaccination

  19. 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

    Measured: 3 weeks after 2nd vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionApr 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
4,902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00644059
Sponsor's protocol ID
V70P5
Other IDs
Eudract number 2007-003786-41
Status last verified
Aug 2015
First submitted
20 Mar 2008
Last updated
18 Sep 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21995388

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine and Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine in people with Influenza, Human, run by Novartis at 101 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in Germany, Finland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00644059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.

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