Healthy volunteers (immunisation against influenza in male and female subjects 18 to 47 months of age inclusive).
Conditions
Interventions
Trade Name: Fluarix™
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: A/Brisbane/59/2007 (H1N1) -like strain
Other descriptive name: TRIVALENT INACTIVATED INF
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject’s parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. • A male or female child between, and including, 18 and 47 months of age at the time of the first vaccination. • Written informed consent obtained from the par-ent(s)/LAR(s) of the subject. • Children who had not received 2 doses of influenza vaccine in a previous season. • In addition, primed subjects from the 111751 study (FluarixUS-007) willing to participate in this study had to satisfy the following criterion at study entry: • Children who had received 2 doses of Fluarix (0.5 mL) in the 111751 study (FluarixUS-007). Are the trial subjects under 18? yes Number of subjects for this age range: 599 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 (including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium de-oxycholate). • 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, cardio-vascular, hepatic or renal functional abnormality, as de-termined by medical history and physical examination. • Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. All vaccines could be adminis-tered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F) or rectal temperature <38.0°C (100.4°F). • 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 im-munodeficient condition based on medical history and physical examination (no laboratory testing required). • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination (for corti-costeroids, this meant prednisone greater than or equal to 10 milligram/day (10 mg/day), or equivalent). Inhaled and topical steroids were allowed. • Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vac-cine or planned administration during the study period. • Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the quadrivalent influ-enza study vaccine (FLU D-QIV) compared to the trivalent influenza vaccine (Fluarix™) in primed and unprimed subjects for the three recommended seasonal strains, 28 days after the last vaccination.;Secondary Objective: • To assess immunological superiority in terms of GMTs of quadrivalent FLU D-QIV compared to trivalent Fluarix for the B strain not included in the trivalent vaccine. • To assess the immune response elicited by the study vaccines when primed with B-Yamagata strain and vacci-nated with B-Victoria or B-Yamagata strains: ?- To assess the immunological superiority in terms of GMTs for the B-Yamagata strain in primed subjects following one FLU D-QIV dose compared to unprimed subjects ?- To assess the immunological superiority in terms of GMTs for the B-Victoria strain in primed subjects following one dose with either Fluarix or FLU D-QIV) compared to unprimed subjects: • To assess the humoral immune response in each vaccine group • To assess the safety and reactogenicity of the study vaccines during the entire study period: solicited symptoms during 7 days, unsolicited symptoms during 28 days, adverse events of special interest and serious adverse events during 6 months. ;Primary end point(s): Humoral immune response in terms of haemagglutinin inhibition (HI) antibody Global Mean Titres (GMT) to each strain of FLU D-QIV.;Timepoint(s) of evaluation of this end point: At pre-vaccination (Day 0) and 28 days after the last vaccine dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Humoral immune response in terms of haemagglutinin inhibition (HI) antibody global mean titre (GMT), seropositivity, sero-conversion rate (SCR), seroconversion factor (SCF), and sero-protection rate (SPR), to each of the four vaccine strains - Occurrence of solicited local and general symptoms - Occurrence of unsolicited adverse events (AE) - Occurrence of adverse events of specific interest (AESI), and serious adverse events (SAE);Timepoint(s) of evaluation of this end point: - Humoral immune response: On Day 0 and 28 days after last vaccine dose - Solicited local and general symptoms: during a 7-day follow-up period after dose 1 (at Day 0) or dose 2 (at Day 28) - Unsolicited adverse events (AE): During a 28-day follow-up period (i.e., day of vaccination and 27 subsequent days) - Adverse events of specific interest (AESI), and serious adverse events (SAE): During the entire study period (Day 0 to Day 180). | — |
Countries
Mexico
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed