Clinical trial NCT00980005: Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Official title: Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: GSK Biologicals influenza vaccine GSK1557482A
influenza infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 2116
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.


Eligibility criteria: Inclusion Criteria:

* Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
* A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
* Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
* 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 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:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
* Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
* Child in care
* Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of hypersensitivity to any vaccine.
* History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Acute disease and/or fever at the time of enrolment.
* 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.
* Pregnant or lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* 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.

Primary outcomes:
measure: Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
timeFrame: At Day 0 and 28 after last vaccine dose.
measure: Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
timeFrame: At Day 28 after last vaccine dose.
Secondary outcomes:
measure: Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
timeFrame: At Day 0 and 28 after last vaccine dose.
measure: Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
timeFrame: At Day 28 after last vaccine dose.
measure: Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
timeFrame: At Day 0 and 28 after last vaccine dose.
measure: Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
timeFrame: At Day 0 and 28 after last vaccine dose.
measure: Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
timeFrame: At Day 0 and at Day 28 after last vaccine dose
measure: Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
timeFrame: At Day 0 and at Day 28 after last vaccine dose
measure: Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
timeFrame: During a 4-day follow-up period (Days 0-3) after vaccination.
measure: Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
timeFrame: During a 4-day follow-up period (Days 0-3) after vaccination.
measure: Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
timeFrame: During a 4-day follow-up period (Days 0-3) after vaccination.
measure: Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
timeFrame: During a 4-day follow-up period (Days 0-3) after vaccination.
measure: Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
timeFrame: During a 28 day follow-up period (Days 0-27) after vaccination.
measure: Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
timeFrame: During a 28 day follow-up period (Days 0-27) after vaccination.
measure: Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
timeFrame: During the entire study period (From Day 0 up to Day 180).
measure: Number of Subjects Reporting Serious Adverse Events (SAEs).
timeFrame: During the entire study period (From Day 0 up to Day 180).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Benton
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: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: DeKalb
country: United States
facility: GSK Investigational Site
state: Illinois
city: Newton
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Woburn
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Cortland
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Cary
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Austintown
country: United States
facility: GSK Investigational Site
state: Ohio
city: Albany
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Provo
country: United States
facility: GSK Investigational Site
state: Utah
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
citation: Domachowske JB, Blatter M, Chandrasekaran V, Liu A, Jain VK, Fries L. A randomized, controlled trial in children to assess the immunogenicity and safety of a thimerosal-free trivalent seasonal influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924.