Clinical trial NCT01974895: Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Children
Immunogenicity
Fluzone®
6 to 35 months of age
Seasonal influenza
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-11-03
Enrollment: 316
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

Detailed description: The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.

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 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Prior receipt of any seasonal or pandemic influenza vaccine 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; 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 enrollment.

  * Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
  * Subjects with a minor illness 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.

Primary outcomes:
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
timeFrame: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
Secondary outcomes:
measure: Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
timeFrame: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
timeFrame: On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
timeFrame: At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)
measure: Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.
timeFrame: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Fever
timeFrame: During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination
measure: Duration of Solicited Local and General Symptoms
timeFrame: During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination
measure: Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
timeFrame: During the entire study period (Day 0 to Day 180)
measure: Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)
timeFrame: During the entire study period (Day 0 to Day 180)
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 - Day 180)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Altamonte Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Woburn
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Barnwell
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Cheraw
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: