AzTrials
AzTrials

Influenza VirusPhase 3NCT01964989

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

A Phase 3 study testing Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) in people with Influenza Virus, run by Seqirus at 167 sites in 11 countries.

Completed

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

Official record
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Trial summary

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season. Read more about this study

Who is it for?
Ages 6 to 71 monthsHealthy volunteers can take part
Conditions the study is for
Influenza Virus
What is being tested?
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,644 participants
Where
167 sitesin 11 countries
Study dates
Nov 2013to Aug 2016
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, males and females, healthy or at high risk of complications from influenza, between ≥6 months to <72 months of age
  • Documented consent provided by the subject's parent(s)/legal guardian(s)
  • Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.

Who cannot join

  • Children with history of allergy to vaccine components.
  • Additional eligibility criteria may be discussed by contacting the site

Trial locations and contacts

167 sites in 11 countries.

167 sites in 11 countries

United States91 sites

  • 240, Novartis Investigational Site

    Akron, Ohio, 44311

  • 259, Novartis Investigational Site

    Anaheim, California, 92801

  • 280, Novartis Investigational Site

    Anaheim, California, 92804

  • 220, Novartis Investigational Site

    Anderson, South Carolina, 29621

  • 262, Novartis Investigational site

    Annapolis, Maryland, 21401

  • 401, Novartis iNvestiagtional Site

    Atlanta, Georgia, 30322

  • 209, Novartis Investigational Site

    Augusta, Kansas, 67010

  • 208, Novartis Investigational Site

    Austin, Texas, 78705

  • 213, Novartis Investigational Site

    Baldwin Park, California, 91706

  • 269, Novartis Investigational Site

    Bardstown, Kentucky, 40004

  • 406, novartis Investigational Site

    Barnwell, South Carolina, 29812

  • 221, Novartis Investigational Site

    Bellevue, Nebraska, 68005

  • 255, Novartis Investigational Site

    Binghamton, New York, 13901

  • 229, Novartis Investigational Site

    Boca Raton, Florida, 33432

  • 409, Novartis Investigational Site

    Boone, North Carolina, 28607

  • 414, Novartis Investigational Site

    Brooklyn, New York, 11201

  • 251, Novartis Investigational Site

    Burke, Virginia, 22015

  • 266, Novartis Investigational Site

    Cary, North Carolina, 27518

  • 222, Novartis Investigational Site

    Chandler, Arizona, 85224

  • 272, Novartis Investigational Site

    Charleston, South Carolina, 29407

  • 254, Novartis Investigational Site

    Cleveland, Ohio, 44122

  • 403, Novartis Investigational Site

    Clyde, North Carolina, 28721

  • 243, Novartis Investigational Site

    Colorado Springs, Colorado, 80902

  • 245, Novartis Investigational Site

    Dayton, Ohio, 45406

  • 281, Novartis Investigational Site

    Dayton, Ohio, 45409

  • 281, Novartis Investigational vaccines

    Dayton, Ohio, 45409

  • 299, Novartis Investigational Site

    DeKalb, Illinois, 60115

  • 249, Novartis Investigational Site

    Denver, Colorado, 80902

  • 407, Novartis Investigational Site

    Downey, California, 90241

  • 292, Novartis Investigational Site

    Erie, Pennsylvania, 16505

  • 247, Novartis Investigational Site

    Fort Worth, Texas, 76107

  • 217, Novartis Investigational Site

    Fort Worth, Texas, 76135

  • 263, Novartis Investigational Site

    Frederick, Maryland, 21702

  • 219, Novartis Investigational Site

    Fremont, Nebraska, 68025

  • 267, Novartis Investigational Site

    Harrisburg, Arkansas, 72432

  • 265, Novartis Investigational Site

    Haughton, Louisiana, 71037

  • 244, Novartis Investigational Site

    Henderson, Nevada, 89014

  • 416, Novartis Investigational Site

    Hialeah, Florida, 33013

  • 287, Novartis Investigational Site

    Hialeah, Florida, 33106

  • 412, Novartis Investigational Site

    Homestead, Florida, 34239

  • 238, Novartis Investigational Site

    La Puente, California, 91774

  • 286, Novartis Investigational site

    Las Vegas, Nevada, 89106

  • 295, Novartis Investigational Site

    Layton, Utah, 84041

  • 226, Novartis Investigational Site

    Louisville, Kentucky, 40202

  • 248, Novartis Investigational Site

    Louisville, Kentucky, 40217

  • 207, Novartis Investigational Site

    Louisville, Kentucky, 40291

  • 290, Novartis Investigational Site

    Louisville, Kentucky, 40291

  • 408, Novartis Investigational Site

    Mangham, Louisiana, 71259

  • 224, Novartis Investigational Site

    Melbourne, Florida, 32935

  • 225, Novartis Investigational Site

    Metairie, Louisiana, 70006

  • 233, Novartis Investigational Site

    Metairie, Louisiana, 70006

  • 417, Novartis Investigational Site

    Miami, Florida, 33015

  • 404, Novartis Investigational Site

    Miami, Florida, 33144

  • 285, Novartis Investigational Site

    Miami, Florida, 33172

  • 277,Novartis Investigational Site

    Miami, Florida, 33412

  • 232, Novartis Investigational Site

    Moncks Corner, South Carolina, 29461

  • 418, Novartis Investigational SIte

    Monroe, Louisiana, 71201

  • 283, Novartis Investigational Site

    Nashville, Tennessee, 37203

  • 210, Novartis Investigational Site

    Newton, Kansas, 67114

  • 402, Novartis Investigational Site

    Omaha, Nebraska, 68114

  • 288, Novartis Investigational Site

    Omaha, Nebraska, 68131

  • 228, Novartis Investigational Site

    Omaha, Nebraska, 68134

  • 411, Novartis Investigational Site

    Ontario, California, 91762

  • 234, Novartis Investigational Site

    Opa-locka, Florida, 33054

  • 297, Novartis Investigational Site

    Orlando, Florida, 32801

  • 297, Novartis Investigational vaccine

    Orlando, Florida, 32806

  • 202, Novartis Investigational Site

    Paramount, California, 90723

  • 274 Novartis Investigational Site

    Park City, Kansas, 67219

  • 268, Novartis Investigational Site

    Peoria, Illinois, 61602

  • 278, Novartis Investigational Site

    Saint Paul, Minnesota, 55108

  • 236, Novartis Investigational Site

    Salt Lake City, Utah, 84109

  • 212, Novartis Investigational Site

    Salt Lake City, Utah, 84121

  • 246, Novartis Investigational Site

    Salt Lake City, Utah, 84124

  • 214, Novartis Investigational Site

    San Angelo, Texas, 76904

  • 400, Novartis investigational Site

    San Antonio, Texas, 78229

  • 250, Novartis Investigational Site

    San Diego, California, 92103

  • 293, Novartis Investigational Site

    San Francisco, California, 94102

  • 410, Novartis Investigational Site

    Sarasota, Florida, 34239

  • 270, Novartis Investigational Site

    Scottdale, Pennsylvania, 15683

  • 405, Novartis Investigational Site

    Silver Spring, Maryland, 20910

  • 279, Novartis Investigational Site

    Spanish Fork, Utah, 84660

  • 291, Novartis Investigational vaccine

    Spartanburg, South Carolina, 27262

  • 264, Novartis Investigational Site

    Syracuse, New York, 13057

  • 282, Novartis Investigational Site

    Syracuse, Utah, 84075

  • 260, Novartis Investigational Site

    Tomball, Texas, 77375

  • 256, Novartis Investigational Site

    Tulsa, Oklahoma, 74127

  • 296, Novartis Investigational Site

    Vienna, Virginia, 22180

  • 294, Novartis Investigational Site

    West Haven, Utah, 84401

  • 201, Novartis Investigational Site

    West Jordan, Utah, 84088

  • 271, Novartis Investigational Site

    West Jordan, Utah, 84088

  • 211, Novartis Investigational Site

    Wichita, Kansas, 67205

Other trials in United States

Poland13 sites

  • 040, Novartis Investigational Site

    Dębica, 39-200

  • 042, Novartis Investigational Site

    Katowice, 40-018

  • 052, Novartis Investigational Site

    Łęczna, 21-010

  • 048, Novartis Investigational Site

    Lodz, 91347

  • 049, Novartis Investigational Site

    Lubartów, 21-100

  • 051, Novartis Investigational Site

    Oborniki Śląskie, 55-120

  • 046, Novartis Investigational Site

    Osielsko, 86-031

  • 043, Novartis Investigational Site

    Siemianowice Śląskie, 41-103

  • 047, Novartis Investigational Site

    Tarnów, 33-100

  • 041, Novartis Investigational Site

    Warsaw, 01809

  • 050, Novartis Investigational Site

    Warsaw, 04-730

  • 045, Novartis Investigational Site

    Wola, 43-225

  • 044, Novartis Investigational Site

    Wroclaw, 51215

Other trials in Poland

Finland11 sites

  • 001, Novartis Investigational Site

    Espoo, FI-02230

  • 003, Novartis Investigational Site

    Helsinki, FIN-00100

  • 002, Novartis Investigational Site

    Helsinki, FIN-00930

  • 004, Novartis Investigational Site

    Jarvenpaa, FIN-04400

  • 005, Novartis Investigational Site

    Kokkola, FI-67100

  • 006, Novartis Investigational Site

    Oulu, 90220

  • 007, Novartis Investigational Site

    Pori, FI-28100

  • 008, Novartis Investigational Site

    Seinäjoki, FI-60100

  • 009, Novartis Investigational Site

    Tampere, FIN-33100

  • 010, Novartis Investigational Site

    Turku, FIN-20520

  • 011, Novartis Investigational Site

    Vantaa, FIN-01300

Other trials in Finland

Italy9 sites

  • 030, Novartis Investigational Site

    Florence, 50139

  • 023, Novartis Investigational Site

    Genova, 16132

  • 020, Novartis Investigational Site

    Milan, 20122

  • 026, Novartis Investigational Site

    Milan, 20157

  • 025, Novartis Investigational Site

    Naples, 80131

  • 021, Novartis Investigational Site

    Novara, 28100

  • 022, Novartis Investigational Site

    Padova, 35128

  • 024, Novartis Investigational Site

    Pisa, 56126

  • 028, Novartis Investigational Site

    Sassari, 07100

Other trials in Italy

Thailand8 sites

  • 320, Novartis Investigational Site

    Bangkok, 10400

  • 324, Novartis Investigational Site

    Bangkok, 10400

  • 321, Novartis Investigational Site

    Bangkoknoi, Bangkok, 10700

  • 322, Novartis Investigational Site

    Bangkoknoi, Bangkok, 10700

  • 326, Novartis Investigational Site

    Hat Yai, Songkhia, 90110

  • 325, Novartis Investigational Site

    Pathum Thani, Changwat Pathum Thani, 12120

  • 323, Novartis Investigational Site

    Pathum Wan, Bangkok, 10330

  • 327, Novartis Investigational Site

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

Philippines7 sites

  • 306, Novartis Investigational Site

    Alabang, Muntilupa, 1781

  • 303, Novartis Investigational Site

    City of Muntinlupa, 1781

  • 304, Novartis Investigational Site

    City of Muntinlupa, 1781

  • 305, Novartis Investigational Site

    City of Muntinlupa, 1781

  • 300, Novartis Investigational Site

    Dasmariñas, Cavite, 4114

  • 302, Novartis Investigational Site

    Manila, 1000

  • 301, Novartis Investigational Site

    Manila, 1001

Other trials in Philippines

Spain7 sites

  • 074, Novartis Investigational Site

    Granada, 18009

  • 076, Novartis Investigational Site

    Madrid, 28041

  • 077, Novartis Investigational Site

    Madrid, 28046

  • 79, Novartis Investigational Site

    Málaga, 29011

  • 80, Novartis Investigational Site

    Sabadell, Barcelona, 08208

  • 075, Novartis Investigational Site

    Santiago de Compostela, Galicia, 15701

  • 078, Novartis Investigational Site

    Valencia, 46026

Other trials in Spain

Taiwan7 sites

  • 343, Novartis Investigational Site

    Banqiao District, New Taipei City, 220

  • 346, Novartis Investigational Site

    Datong, Taipei City, 10341

  • 344, Novartis Investigational Site

    Taichung, 40447

  • 345, Novartis Investigational Site

    Taichung, 40705

  • 340, Novartis Investigational Site

    Taipei, 10041

  • 341, Novartis Investigational Site

    Taipei, 10449

  • 342, Novartis Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Mexico6 sites

  • 176, Novartis Investigational Site

    Durango, 34000

  • 170, Novartis Investigational Site

    México, 04530

  • 177, Novartis Investigational Site

    México, 06760

  • 178, Novartis Investigational Site

    México, 14000

  • 175, Novartis Investigational Site

    México, 7020

  • 173, Novartis Investigational Site

    Morelia, Michoacán, 58070

Other trials in Mexico

Canada5 sites

  • 184, Novartis Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • 180, Novartis Investigational Site

    Newmarket, Ontario, L3Y 5G8

  • 183, Novartis Investigational Site

    Québec, G1E 7G9

  • 186, Novartis Investigational Site

    Québec

  • 182,Novartis Investigational Site

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Puerto Rico3 sites

  • 257, Novartis Investigational Site

    Ponce, 00716

  • 415, Novartis Investigational vaccine

    San Juan, 00909

  • 415, Novartis Investigational Site

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Conditions
Influenza Virus
Being tested
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
Keywords
Influenza, 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 Quadrivalent Subunit Influenza Virus Vaccine (aQIV)Biological

    1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

  • Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)Biological

    1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

Study groups in NCT01964989
Study groupRoleWhat they receive
aQIVExperimentalflu vaccine
Receives: Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
non-adjuvanted comparatorActive comparatorflu vaccine
Receives: Biological: Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)

What is being measured

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

  1. Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Secondary outcomes (22)

  1. Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age.

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

  2. Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

  3. Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to <72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

  4. Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

  5. Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥7 days and at ≥14 days after first vaccination up to day of second vaccination

  6. Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects.

    Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).

    Measured: ≥7 days and ≤21 days after the last vaccination

  7. Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age

    Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.

    Measured: Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects

  8. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age

    GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.

    Measured: Day 29 and Day 50

  9. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age

    HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments.

    Measured: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

  10. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age

    The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.

    Measured: Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects

  11. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age

    SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine.

    comparison analysis (N=745 for aQIV, N=738 for comparator).

    Measured: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

  12. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age

    Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.

    Measured: Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects)

  13. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age

    Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.

    Measured: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

  14. Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age

    HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.

    Measured: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

  15. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age

    SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups

    Measured: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

  16. Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age

    Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.

    Measured: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

  17. Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs

    Subjects ≥6 to <72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV.

    Measured: 7 days following each vaccination

  18. Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs

    Safety was assessed in terms of number of subjects ≥6 to <72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination.

    Measured: Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive)

  19. Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza

    Measured: within a window of 14 days after influenza-like illness (ILI)-onset

  20. Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza

    Measured: within a window of 14 days after ILI-onset

  21. Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza

    Measured: within a window of 14 days after ILI-onset

  22. Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2.

    Measured: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer

Timeline

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

  1. First posted17 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionOct 2015
  4. Study completionAug 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10,644 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01964989
Sponsor's protocol ID
V118_05
Other IDs
2012-000218-12
Status last verified
Mar 2023
First submitted
15 Oct 2013
Last updated
27 Mar 2023
Data monitoring committee
Yes

Publications

  • Esposito S, Fling J, Chokephaibulkit K, de Bruijn M, Oberye J, Zhang B, Vossen J, Heijnen E, Smolenov I. Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial. Pediatr Infect Dis J. 2020 Aug;39(8):e185-e191. doi: 10.1097/INF.0000000000002727.

    PubMed 32404782

  • Vesikari T, Kirstein J, Devota Go G, Leav B, Ruzycky ME, Isakov L, de Bruijn M, Oberye J, Heijnen E. Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial. Lancet Respir Med. 2018 May;6(5):345-356. doi: 10.1016/S2213-2600(18)30108-5. Epub 2018 Apr 6.

    PubMed 29631857

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) and Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) in people with Influenza Virus, run by Seqirus at 167 sites in 11 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 3 inclusion and 2 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Poland, Finland, Italy, Thailand and 6 more countries. 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. 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 27 Mar 2023). 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?

Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age (time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer). 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 NCT01964989, which also lists 2 linked publications.

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 27 Mar 2023.

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