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InfluenzaPhase 3NCT02242643

Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

A Phase 3 study testing FluLaval™ Quadrivalent and Fluzone® Quadrivalent in people with Influenza, run by GlaxoSmithKline at 66 sites in 2 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 assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent 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?
FluLaval™ Quadrivalent and Fluzone® Quadrivalent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,432 participants
Where
66 sitesin 2 countries
Study dates
1 Oct 2014to 23 Jun 2015
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' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, 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 the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
  • Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
  • Child in care.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean a dose equivalent to either > 2 mg/kg/day of body weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when administered for more than 2 weeks. Inhaled and topical steroids are allowed.
  • Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within six months preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
Show all 13Show fewer
  • Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature ≥ 38.0°C/100.4°F by any route.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Trial locations and contacts

66 sites in 2 countries.

66 sites in 2 countries

United States64 sites

  • GSK Investigational Site

    Anaheim, California, 92804

  • GSK Investigational Site

    Augusta, Kansas, 67010

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Beavercreek, Ohio, 45431

  • GSK Investigational Site

    Binghamton, New York, 13901

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Bossier City, Louisiana, 71111

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charlottesville, Virginia, 22902

  • GSK Investigational Site

    Cheraw, South Carolina, 29520

  • GSK Investigational Site

    Chino, California, 91710

  • GSK Investigational Site

    Cleveland, Ohio, 44121

  • GSK Investigational Site

    Colorado Springs, Colorado, 80920

  • GSK Investigational Site

    Colorado Springs, Colorado, 80922

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    Daly City, California, 94015

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    Dothan, Alabama, 36305

  • GSK Investigational Site

    Ellensburg, Washington, 98926

  • GSK Investigational Site

    Erie, Pennsylvania, 16505

  • GSK Investigational Site

    Fort Worth, Texas, 76135

  • GSK Investigational Site

    Fresno, California, 93726

  • GSK Investigational Site

    Galveston, Texas, 77555-1119

  • GSK Investigational Site

    Hayward, California, 94545

  • GSK Investigational Site

    Hermitage, Pennsylvania, 16148

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Lake Mary, Florida, 32736

  • GSK Investigational Site

    Las Vegas, Nevada, 89104

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Lincoln, Nebraska, 68504

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Lincoln, Nebraska, 68516

  • GSK Investigational Site

    Louisville, Kentucky, 40291

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami Lakes, Florida, 33014

  • GSK Investigational Site

    Nampa, Idaho, 83686

  • GSK Investigational Site

    Newton, Kansas, 67114

  • GSK Investigational Site

    Oakland, California, 94611

  • GSK Investigational Site

    Orem, Utah, 84057

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Payson, Utah, 84651

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Pleasanton, California, 94588

  • GSK Investigational Site

    Provo, Utah, 84604

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Roy, Utah, 84067

  • GSK Investigational Site

    Sacramento, California, 95815

  • GSK Investigational Site

    Sacramento, California, 95822

  • GSK Investigational Site

    Sacramento, California, 95823

  • GSK Investigational Site

    Salt Lake City, Utah, 84124

  • GSK Investigational Site

    Santa Clara, California, 95051

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    South Jordan, Utah, 84095

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Topeka, Kansas, 66604

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Walnut Creek, California, 94596

  • GSK Investigational Site

    West Covina, California, 91790

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Woburn, Massachusetts, 01801

Other trials in United States

Mexico2 sites

  • GSK Investigational Site

    Mexico City, 04530

  • GSK Investigational Site

    San Nicolás de los Garza, Nuevo León, 66480

Other trials in Mexico

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.

Conditions
Influenza
Being tested
FluLaval™ Quadrivalent, Fluzone® Quadrivalent
Keywords
Fluzone Quadrivalent, Comparator, Children, Seasonal influenza, Safety, Immunogenicity
Medical subject headings
Influenza, Human

What participants receive

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

  • FluLaval™ QuadrivalentBiological

    Also called FLU Q-QIV (GSK2282512A)

    1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively

  • Fluzone® QuadrivalentBiological

    Also called F-QIV

    1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively

Study groups in NCT02242643
Study groupRoleWhat they receive
FluLaval™ Quadrivalent GroupExperimentalSubjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
Receives: Biological: FluLaval™ Quadrivalent
Fluzone® Quadrivalent GroupActive comparatorSubjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
Receives: Biological: Fluzone® Quadrivalent

What is being measured

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

  1. Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains

    Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

    The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).

    Measured: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

  2. Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.

    HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

    Measured: At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

Secondary outcomes (12)

  1. Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).

    Measured: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

  2. Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

    Measured: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

  3. Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

    Measured: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

  4. Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

    Measured: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

  5. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.

    Measured: During a 7-day (Day 0 - Day 6) follow-up period after each vaccination

  6. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.

    Measured: During the 7-day (Days 0-6) follow-up period after each vaccination

  7. Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

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

    Measured: During the 7-day (Days 0-6) follow-up period after each vaccination.

  8. Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.

    Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature < 38.0°C but with missing values for at least one day during the solicited period.

    Grade 3 fever was defined as temperature greater than (>) 39.0°C.

    Measured: During a 2-day (Days 0-1) follow-up period after each vaccination

  9. Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).

    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).

    Measured: During the entire study period (Days 0 -180)

  10. Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    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. Related = symptom assed by the investigator as causally related to the study vaccination.

    Measured: During the entire study period (Days 0 -180)

  11. Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.

    Measured: During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period

  12. Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)

    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 (Days 0 -180)

Timeline

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

  1. First posted17 Sep 2014 (estimated)
  2. Study start1 Oct 2014
  3. Primary completion16 Mar 2015
  4. Study completion23 Jun 2015

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
2,432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242643
Sponsor's protocol ID
201234
Status last verified
Oct 2017
First submitted
15 Sep 2014
Last updated
7 Sep 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FluLaval™ Quadrivalent and Fluzone® Quadrivalent in people with Influenza, run by GlaxoSmithKline at 66 sites in 2 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 5 inclusion and 13 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 7 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 66 sites in United States, Mexico. 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 12 Apr 2016). 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?

Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains (time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)). 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 NCT02242643.

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 7 Sep 2018.

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