Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine GSK2321138A in Healthy Children
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 599
- Locations
- 2
- Primary Endpoint
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
Study Overview
Brief Summary
The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Months to 47 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For all subjects:
- •Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject/from the LAR(s).
- •For unprimed subjects:
- •A male or female child aged 18 to 47 months at the time of the first vaccination.
- •Children who did not have influenza vaccine in a previous season.
- •For primed subjects from study NCT00764790:
- •Children who received Fluarix™ in the 111751 study NCT00764790.
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.
- •History of hypersensitivity to any vaccine.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- •Acute disease at the time of enrolment.
- •History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- •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.
Arms & Interventions
GSK2321138A Group
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
Intervention: Influenza vaccine GSK2321138A (Biological)
Fluarix Group
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
Intervention: Fluarix™ (Biological)
Outcomes
Primary Outcomes
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
Time Frame: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
Secondary Outcomes
- Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.(At Days 28 and 56)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At Days 28 and 56)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 7-day follow-up period (Days 0 to 6) after any vaccination)
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.(At Days 0, 28 and 56)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At Days 0, 28 and Day 56)
- Number of Seropositive Subjects Against 4 Strains of Influenza Disease.(At Days 0, 28 and 56)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 28-day follow-up period (Days 0 to 27) after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs).(From Day 0 to Day 180 (study conclusion))
- Number of Subjects With Any Adverse Events of Specific Interest (AESIs).(From Day 0 to Day 180 (study conclusion))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day follow-up period (Days 0 to 6) after any vaccination)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At Days 0 and 28.)
- Number of Seropositive Subjects Against 4 Strains of Influenza Disease.(At Days 0 and 28)
- Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.(At Day 28)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At Day 28)
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.(At Days 0 and 28)