Clinical trial NCT01711736: Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age
Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Immunogenicity
Children
Safety
Seasonal influenza
Fluarix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 606
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 investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

Detailed description: The subjects will be randomized (1:1) in the 2 treatment groups to explore responses to vaccination in a sub-group analysis based on age (6 to 17 months, 18 to 35 months).

Eligibility criteria: Inclusion Criteria:

* Subject's 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 the 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.
* 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.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed.
* 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 enrolment.
* 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 Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.
timeFrame: 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 the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects Reporting Any, Grade 3 and Related Fever
timeFrame: During the 7-day (Days 0-6) post-vaccination period
Secondary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
timeFrame: At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
measure: Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine
timeFrame: At Day 28 for primed subjects and at Day 56 for unprimed subjects
measure: Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (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 Haemagglutination Inhibition (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, Grade 3 and Related Fever
timeFrame: During the 4-day (Days 0-3) post-vaccination period
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 the 28-day (Days 0-27) post-vaccination period.
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: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Santo Domingo, Distrito Nacional
country: Dominican Republic
facility: GSK Investigational Site
city: San Pedro Sula
country: Honduras
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bekkat-Berkani R, Ray R, Jain VK, Chandrasekaran V, Innis BL. Evidence update: GlaxoSmithKline's inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 2016;15(2):201-14. doi: 10.1586/14760584.2016.1113878. Epub 2015 Dec 5.
citation: Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK. Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial. J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.