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

NCT ID: NCT02242643

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2015-06-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

FluLaval™ Quadrivalent Group

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).

Group Type: EXPERIMENTAL

FluLaval™ Quadrivalent

Intervention Type: 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

Fluzone® Quadrivalent Group

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).

Group Type: ACTIVE_COMPARATOR

Fluzone® Quadrivalent

Intervention Type: 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

Interventions

FluLaval™ Quadrivalent

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

Intervention Type: BIOLOGICAL

Fluzone® Quadrivalent

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

Intervention Type: BIOLOGICAL

Other Intervention Names

FLU Q-QIV (GSK2282512A); F-QIV

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Dothan, Alabama, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Chino, California, United States

GSK Investigational Site

Daly City, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Hayward, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Paramount, California, United States

GSK Investigational Site

Pleasanton, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Santa Clara, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Lake Mary, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Nampa, Idaho, United States

GSK Investigational Site

Augusta, Kansas, United States

GSK Investigational Site

Newton, Kansas, United States

GSK Investigational Site

Topeka, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Bossier City, Louisiana, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

Woburn, Massachusetts, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Lincoln, Nebraska, United States

GSK Investigational Site

Lincoln, Nebraska, United States

GSK Investigational Site

Lincoln, Nebraska, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Binghamton, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Beavercreek, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Hermitage, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Sellersville, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Cheraw, South Carolina, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Galveston, Texas, United States

GSK Investigational Site

Tomball, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Orem, Utah, United States

GSK Investigational Site

Payson, Utah, United States

GSK Investigational Site

Provo, Utah, United States

GSK Investigational Site

Roy, Utah, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

South Jordan, Utah, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Ellensburg, Washington, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

GSK Investigational Site

San Nicolás de los Garza, Nuevo León, Mexico

GSK Investigational Site

Mexico City, , Mexico

Countries

United States; Mexico

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

201234

Identifier Type: -

Identifier Source: org_study_id