AzTrials
AzTrials

InfluenzaPhase 3NCT01439360

An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

A Phase 3 study testing Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior and Prevenar 13 in people with Influenza, run by GlaxoSmithKline at 103 sites in 13 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

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior and Prevenar 13
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,046 participants
Where
103 sitesin 13 countries
Study dates
1 Oct 2011to 31 Dec 2014
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 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
  • Written informed consent obtained from the parent(s) /LAR(s) of the subject.
  • Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Who cannot join

  • Participation in a previous FLU-D-QIV-004 study (115345) cohort.
  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
  • Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
Show all 18Show fewer
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
  • Any contraindication to intramuscular injection.
  • Acute disease and/or fever at the time of enrolment.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
  • Additional criteria for children ≥ 12 months of age:
  • Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.
  • For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
  • Any history of hepatitis A or varicella diseases.
  • Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
  • Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.

Trial locations and contacts

103 sites in 13 countries.

103 sites in 13 countries

Spain24 sites

  • GSK Investigational Site

    Antequera/Málaga, 29200

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08042

  • GSK Investigational Site

    Blanes (Girona), 17300

  • GSK Investigational Site

    Boadilla del Monte, 28660

  • GSK Investigational Site

    Castellon, 12004

  • GSK Investigational Site

    Castellon, 12530

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28700

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28224

  • GSK Investigational Site

    Quart de Poblet, Valencia, 46930

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Seville, 41927

  • GSK Investigational Site

    Torrelodones (Madrid), 28250

  • GSK Investigational Site

    Valencia, 46011

  • GSK Investigational Site

    Valencia, 46024

  • GSK Investigational Site

    Valencia, 46200

  • GSK Investigational Site

    Valencia, 46702

  • GSK Investigational Site

    Vic/ Barcelona, 08500

  • GSK Investigational Site

    Xativa/Valencia, 46800

Other trials in Spain

Poland21 sites

  • GSK Investigational Site

    Bydgoszcz, 85-079

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Bydgoszcz, 85-316

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Gdansk, 84-462

  • GSK Investigational Site

    Grudziądz, 86-330

  • GSK Investigational Site

    Katowice, 40-018

  • GSK Investigational Site

    Katowice, 40-129

  • GSK Investigational Site

    Krakow, 31-223

  • GSK Investigational Site

    Łęczna, 21-010

  • GSK Investigational Site

    Lodz, 90-242

  • GSK Investigational Site

    Lublin, 20-044

  • GSK Investigational Site

    Oborniki, 55-120

  • GSK Investigational Site

    Poznan, 61-709

  • GSK Investigational Site

    Poznan, 62-064

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Torun

  • GSK Investigational Site

    Warsaw, 00-315

  • GSK Investigational Site

    Wola, 43-225

  • GSK Investigational Site

    Wroclaw, 52-312

Other trials in Poland

United Kingdom20 sites

  • GSK Investigational Site

    Atherstone, Warwickshire, CV9 1EU

  • GSK Investigational Site

    Axbridge, Somerset, BS26 2BJ

  • GSK Investigational Site

    Bath, Somerset, BA1 3NG

  • GSK Investigational Site

    Belfast, BT7 2EB

  • GSK Investigational Site

    Bolton, Nr Manchester, BL3 6TL

  • GSK Investigational Site

    Bristol, BS2 8AE

  • GSK Investigational Site

    Co Antrim, BT41 3AE

  • GSK Investigational Site

    Coventry, Warwickshire, CV6 4DD

  • GSK Investigational Site

    Crumpsall, Manchester, M8 9JT

  • GSK Investigational Site

    Exeter, EX2 5DW

  • GSK Investigational Site

    Gloucester, GL1 3NN

  • GSK Investigational Site

    London, SW17 0QT

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Nottingham, NG7 2QW

  • GSK Investigational Site

    Oxford, OX3 7LJ

  • GSK Investigational Site

    Southampton, Hampshire, SO16 6YD

  • GSK Investigational Site

    St Austell, Cornwall, PL26 7RL

  • GSK Investigational Site

    Taunton, Somerset, TA1 5DA

  • GSK Investigational Site

    Westminster Bridge Road, SE1 7EH

  • GSK Investigational Site

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Czechia11 sites

  • GSK Investigational Site

    Děčín, 405 01

  • GSK Investigational Site

    Humpolec, 396 01

  • GSK Investigational Site

    Jindřichův Hradec, 37701

  • GSK Investigational Site

    Liberec, 46015

  • GSK Investigational Site

    Lipník nad Bečvou, 75131

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Odolena Voda, 25070

  • GSK Investigational Site

    Ostrava - Poruba, 70800

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Prague, 1600

  • GSK Investigational Site

    Tábor, 390 02

Other trials in Czechia

Belgium7 sites

  • GSK Investigational Site

    Antwerp, 2018

  • GSK Investigational Site

    Antwerp, 2020

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Mechelen, 2800

  • GSK Investigational Site

    Namur, 5000

  • GSK Investigational Site

    Roeselaere, 8800

  • GSK Investigational Site

    Turnhout, 2300

Other trials in Belgium

Philippines6 sites

  • GSK Investigational Site

    City of Muntinlupa, 1781

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Manila

  • GSK Investigational Site

    Metro Manila, 1000

  • GSK Investigational Site

    Quezon City, 1113

  • GSK Investigational Site

    Sampaloc, Manila, 1008

Other trials in Philippines

India3 sites

  • GSK Investigational Site

    Faridabad, 121004

  • GSK Investigational Site

    Pune, 411 011

  • GSK Investigational Site

    Pune

Other trials in India

Turkey (Türkiye)3 sites

  • GSK Investigational Site

    Bursa

  • GSK Investigational Site

    Eskişehir

  • GSK Investigational Site

    Istanbul, 34890

Other trials in Turkey (Türkiye)

Dominican Republic2 sites

  • GSK Investigational Site

    Santo Domingo

  • GSK Investigational Site

    Santo Domingo, Distrito Nacional

Other trials in Dominican Republic

Honduras2 sites

  • GSK Investigational Site

    San Pedro Sula

  • GSK Investigational Site

    Tegucigalpa

Other trials in Honduras

Thailand2 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Khon Kaen, 40002

Other trials in Thailand

Bangladesh1 site

  • GSK Investigational Site

    Dhaka, 1000

Other trials in Bangladesh

Lebanon1 site

  • GSK Investigational Site

    Beirut, 1107-2020

Other trials in Lebanon

About this study

Official title: An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

Conditions
Influenza
Being tested
Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior, Prevenar 13, Varivax/ProVarivax, Varilrix
Keywords
Vaccine, Seasonal Flu, Efficacy, 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.

  • Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138ABiological

    Intramuscular injection

  • Havrix JuniorBiological

    Intramuscular injection administered to subjects aged 12 months or older

  • Prevenar 13Biological

    Intramuscular injection administered to subjects less than 12 months of age

  • Varivax/ProVarivaxBiological

    Intramuscular injection administered to subjects more than 12 months of age

  • VarilrixBiological

    Subcutaneous injection administered to subjects more than 12 months of age

Study groups in NCT01439360
Study groupRoleWhat they receive
D-QIVExperimentalSubjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
Receives: Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
ControlActive comparatorIn function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Receives: Biological: Havrix Junior; Biological: Prevenar 13; Biological: Varivax/ProVarivax; Biological: Varilrix

What is being measured

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

  1. Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

  2. Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

Secondary outcomes (20)

  1. Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)

  2. Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

  3. Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

  4. Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

  5. Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

  6. Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)

  7. Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.

    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

    Measured: During the surveillance period (approximately 6 to 8 months)

  8. Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)

    Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).

    PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects

    Measured: At Days 0 and 28/56

  9. Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)

    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).

    PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.

    Measured: At Day 0 and Day 28/56

  10. Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)

    Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus.

    PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects

    Measured: At Day 28/56 (POST)

  11. Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).

    MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).

    POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.

    Measured: At Day 28/56 (POST)

  12. Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)

    Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).

    PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects

    Measured: At Day 0 and Day 28/56

  13. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.

    Measured: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

  14. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

    Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.

    Measured: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

  15. Duration of Solicited Local Symptoms

    Duration was defined as number of days with any grade of local symptoms.

    Measured: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

  16. Duration of Solicited General Symptoms

    Duration was defined as number of days with any grade of general symptoms.

    Measured: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

  17. Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

    Measured: During the 28-day (Days 0-27) post-vaccination period

  18. Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)

    MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.

    Measured: During the entire study period (approximately 6- 8 months per subject)

  19. Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).

    pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.

    Measured: During the entire study period (approximately 6- 8 months per subject)

  20. Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.

    Measured: During the entire study period (approximately 6- 8 months per subject)

Timeline

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

  1. First posted23 Sep 2011 (estimated)
  2. Study start1 Oct 2011
  3. Primary completion31 Oct 2014
  4. Study completion31 Dec 2014

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
12,046 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01439360
Sponsor's protocol ID
115345
Other IDs
2011-000758-41
Status last verified
Aug 2018
First submitted
21 Sep 2011
Last updated
26 Sep 2018
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Danier J, Callegaro A, Soni J, Carmona A, Kosalaraska P, Rivera L, Friel D, Pu W, Vantomme V, Dbaibo G, Innis BL, Schuind A, Zaman K, Wilson J. Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction-Confirmed Influenza Illness in Children 6-35 Months of Age: Statistical Evaluation of a Correlate of Protection. Open Forum Infect Dis. 2021 Sep 25;9(2):ofab477. doi: 10.1093/ofid/ofab477. eCollection 2022 Feb.

    PubMed 35083365

  • Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL; Flu4VEC Study Group. Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial. Pediatr Infect Dis J. 2020 Jan;39(1):e1-e10. doi: 10.1097/INF.0000000000002504.

    PubMed 31725115

  • Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, Innis BL; Flu4VEC Study Group. Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine. Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387.

    PubMed 31306399

  • Claeys C, Chandrasekaran V, Garcia-Sicilia J, Prymula R, Diez-Domingo J, Brzostek J, Mares-Bermudez J, Martinon-Torres F, Pollard AJ, Ruzkova R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, Jain VK. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children. Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217.

    PubMed 30325891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior and Prevenar 13 in people with Influenza, run by GlaxoSmithKline at 103 sites in 13 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 4 inclusion and 18 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in Spain, Poland, United Kingdom, Czechia, Belgium and 8 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 8 Mar 2017). 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 With Moderate to Severe RT-PCR Confirmed Influenza. (time frame: During the surveillance period (approximately 6 to 8 months)). 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 NCT01439360, which also lists 4 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 26 Sep 2018.

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