Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
- Conditions
- Influenza
- Interventions
- Biological: FluarixBiological: Fluzone
- Registration Number
- NCT00764790
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3317
- A male or female child aged 6 to 35 months 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.
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject's parent/guardian.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- 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 an influenza vaccine outside of this study, during current (2008-09) flu season.
- Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluarix Dose A Group Fluarix Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. Fluzone Group Fluzone Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. Fluarix Dose B Group Fluarix Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
- Primary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains Day 0 (PRE), Day 28 or Day 56 (POST) GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjectsNumber of Subjects Who Seroconverted Day 28 or Day 56 Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
- Secondary Outcome Measures
Name Time Method Number of Subjects Reporting Unsolicited Adverse Events (AE) During a 28-day follow-up period after vaccination An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Seroconversion Factor Day 28 or Day 56 Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjectsNumber of Subjects Reporting Solicited Local Symptoms During a 4-day follow-up period after vaccination Solicited local symptoms assessed include pain, redness and swelling.
Number of Subjects Reporting Solicited General Symptoms During a 4-day follow-up period after vaccination Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.
Number of Seroprotected Subjects Day 0 (PRE), Day 28 or Day 56 (POST) A seroprotected subject is a subject with a serum anti-HA titer
≥ 1:40
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjectsNumber of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD) During the entire study (Day 0 until Month 6) An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disordersNumber of Subjects Reporting Rare Serious Events During the entire study (Day 0 until Month 6) Rare serious events have an occurrence rate of 1/300 (0.3%).
Trial Locations
- Locations (1)
GSK Investigational Site
🇹🇭Bangkok, Thailand