Clinical trial NCT01196988: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: GSK Biologicals influenza vaccine GSK2321138A
influenza infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 3027
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 assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* For non US countries:
* - Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.

For US :

* Children, male or female, aged between 3 and 17 years at the time of the first study vaccination
* Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
* Written informed assent obtained from the subject if/as required by local regulations.
* 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 urine 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 vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Routine registered childhood vaccinations are permitted.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) 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 three months prior to enrolment in this study or planned administration during the study period.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* History of seizures or progressive neurological disease.
* History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* 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 a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
* Acute disease and/or fever at the time of enrolment
* Ongoing aspirin therapy
* Pregnant or lactating female
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study
* Child in Care.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and 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 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
measure: Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
measure: Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
timeFrame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) follow-up period after any vaccination.
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
timeFrame: During the 7-day (Days 0-6) follow-up period after any vaccination.
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
timeFrame: During the 7-day (Days 0-6) follow-up period after any vaccination.
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 28-day (Days 0-27) follow-up period after any vaccination.
measure: Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
timeFrame: During the entire study period (Day 0 - Day 180)
measure: Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
timeFrame: During the entire study period (Day 0 - Day 180)
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Day 0 - Day 180)
measure: Number of Days With Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) follow-up period after vaccination.
measure: Number of Days With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) follow-up period after vaccination.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Elmira
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Angelo
country: United States
facility: GSK Investigational Site
state: Texas
city: Decin
country: Czechia
facility: GSK Investigational Site
city: Humpolec
country: Czechia
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czechia
facility: GSK Investigational Site
city: Kolin
country: Czechia
facility: GSK Investigational Site
city: Nachod
country: Czechia
facility: GSK Investigational Site
city: Odolena voda
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Plzen
country: Czechia
facility: GSK Investigational Site
city: Praha 6
country: Czechia
facility: GSK Investigational Site
city: Tabor
country: Czechia
facility: GSK Investigational Site
city: Aix en Provence
country: France
facility: GSK Investigational Site
city: Draguignan
country: France
facility: GSK Investigational Site
city: Essey les Nancy
country: France
facility: GSK Investigational Site
city: La Bouexiere
country: France
facility: GSK Investigational Site
city: Le Havre
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Seysses
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tauberbischofsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Gilching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kirchheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Dasmariñas, Cavite
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.