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

NCT02242643 | Completed Phase 3 Results

• 1 other identifier: 201234
• Study Type: interventional
• Target: 2,432
• Locations: 2 countries
• Sites: 66

Brief 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.

Conditions

Influenza

Keywords

Fluzone Quadrivalent; Comparator; Children; Seasonal influenza; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

  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)

• 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)

  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)

• 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)

  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)

• 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)

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

• 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)

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

• 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)

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

Study Arms (2)

FluLaval™ Quadrivalent Group

EXPERIMENTAL

Subjects 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).

Biological: FluLaval™ Quadrivalent

Fluzone® Quadrivalent Group

ACTIVE COMPARATOR

Subjects 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).

Biological: Fluzone® Quadrivalent

Interventions

FluLaval™ Quadrivalent BIOLOGICAL

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

Also known as: FLU Q-QIV (GSK2282512A)

FluLaval™ Quadrivalent Group

Fluzone® Quadrivalent BIOLOGICAL

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

Also known as: F-QIV

Fluzone® Quadrivalent Group

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (66)

GSK Investigational Site

Birmingham, Alabama, 35235, United States

Location

GSK Investigational Site

Dothan, Alabama, 36305, United States

Location

GSK Investigational Site

Tucson, Arizona, 85741, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Anaheim, California, 92804, United States

Location

GSK Investigational Site

Chino, California, 91710, United States

Location

GSK Investigational Site

Daly City, California, 94015, United States

Location

GSK Investigational Site

Fresno, California, 93726, United States

Location

GSK Investigational Site

Hayward, California, 94545, United States

Location

GSK Investigational Site

Oakland, California, 94611, United States

Location

GSK Investigational Site

Paramount, California, 90723, United States

Location

GSK Investigational Site

Pleasanton, California, 94588, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

Sacramento, California, 95822, United States

Location

GSK Investigational Site

Sacramento, California, 95823, United States

Location

GSK Investigational Site

Santa Clara, California, 95051, United States

Location

GSK Investigational Site

Walnut Creek, California, 94596, United States

Location

GSK Investigational Site

West Covina, California, 91790, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80920, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80922, United States

Location

GSK Investigational Site

Lake Mary, Florida, 32736, United States

Location

GSK Investigational Site

Miami Lakes, Florida, 33014, United States

Location

GSK Investigational Site

Nampa, Idaho, 83686, United States

Location

GSK Investigational Site

Augusta, Kansas, 67010, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Topeka, Kansas, 66604, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40291, United States

Location

GSK Investigational Site

Bossier City, Louisiana, 71111, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Columbia, Maryland, 21045, United States

Location

GSK Investigational Site

Woburn, Massachusetts, 01801, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68504, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68505, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68516, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89104, United States

Location

GSK Investigational Site

Binghamton, New York, 13901, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Beavercreek, Ohio, 45431, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16505, United States

Location

GSK Investigational Site

Hermitage, Pennsylvania, 16148, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Sellersville, Pennsylvania, 18960, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406, United States

Location

GSK Investigational Site

Cheraw, South Carolina, 29520, United States

Location

GSK Investigational Site

Kingsport, Tennessee, 37660, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Galveston, Texas, 77555-1119, United States

Location

GSK Investigational Site

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Orem, Utah, 84057, United States

Location

GSK Investigational Site

Payson, Utah, 84651, United States

Location

GSK Investigational Site

Provo, Utah, 84604, United States

Location

GSK Investigational Site

Roy, Utah, 84067, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84124, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22902, United States

Location

GSK Investigational Site

Ellensburg, Washington, 98926, United States

Location

GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

Location

GSK Investigational Site

San Nicolás de los Garza, Nuevo León, 66480, Mexico

Location

GSK Investigational Site

Mexico City, 04530, Mexico

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: October 1, 2014
• Primary Completion: March 16, 2015
• Study Completion: June 23, 2015
• Last Updated: September 7, 2018
• Results First Posted: April 12, 2016

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

ME (2); US (64)