Clinical trial NCT01198756: A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children
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: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 3109
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
* A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
* Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
* Written informed assent obtained from the subject if/as required by local regulations.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject

  * Has practiced adequate contraception for 30 days prior to vaccination, and
  * Has a negative pregnancy urine test on the day of vaccination, and
  * Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Child in care
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 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 dose.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* History of Guillain-Barré syndrome within 6 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.
* Fever at the time of enrolment.
* Acute disease at the time of enrolment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Ongoing aspirin therapy.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Number of Subjects Seroconverted Against 4 Strains of Influenza Disease
timeFrame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Number of Subjects Seroprotected Against 4 Strains of Influenza Disease
timeFrame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata
timeFrame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata
timeFrame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata
timeFrame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata
timeFrame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Days With Solicited Local Symptoms After Vaccination
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination
timeFrame: During the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 28-day follow-up period (Day 0-27) after vaccination
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination
timeFrame: During the entire study period (from Day 0 to Day 180)
measure: Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination
timeFrame: During the entire study period (from Day 0 to Day 180)
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 to Day 180)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Harrisburg
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Longmont
country: United States
facility: GSK Investigational Site
state: Colorado
city: Thornton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Niles
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Barnwell
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Mount Pearl
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
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: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Alcala de Guadaira
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Langley JM, Carmona Martinez A, Chatterjee A, Halperin SA, McNeil S, Reisinger KS, Aggarwal N, Huang LM, Peng CT, Garcia-Sicilia J, Salamanca de la Cueva I, Cabanas F, Trevino-Garza C, Rodriguez-Weber MA, de la O M, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. J Infect Dis. 2013 Aug 15;208(4):544-53. doi: 10.1093/infdis/jit263. Epub 2013 Jul 11.