Healthy volunteers (immunisation against influenza in male and female subjects 6 to 35 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) (IVR-148)
Other descriptive name: TRIVALENT INACTIVATED INFLUE
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 were acceptable. •Subjects having a parent/LAR (Legally Appointed Repre-sentative) who the investigator believed could and would comply with the requirements of the protocol (e.g., return their child for follow-up visit and completion of diary cards) were to be enrolled in the study. •Written informed consent obtained from the subject’s parent/LAR. Are the trial subjects under 18? yes Number of subjects for this age range: 3318 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) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations were 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 including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium deoxycholate. •Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines could be administered 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 an influenza vaccine outside of this study, during current (2008-09) flu season. •Administration of immunoglobulins and/or blood products within the 3 month period preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At pre-vaccination (Day 0) and at post-vaccination (Day 28 for primed or Day 56 for unprimed subjects);Main Objective: •To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.5mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination. •To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.25mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination ;Secondary Objective: •To compare local and general solicited AEs, unsolicited AEs, and serious AEs in subjects vaccinated with TF Fluarix (0.5mL) or TF Fluarix (0.25mL) or Fluzone, by dose for solicited AEs only and overall for all AE types. •To compare the immunogenicity of TF Fluarix (0.5mL) to TF Fluarix (0.25mL) and Fluzone pre- and post-vaccination at approximately 28 or 56 days (GMTs, seroconversion rate, seroprotection and seroconversion factor). •To detect rare events, defined as serious adverse events with an occurrence rate of 1/300, in subjects (6 to 35 months of age) vaccinated with each administered volume of TF Fluarix ;Primary end point(s): Serum anti-HA antibody titer against each of the three vaccine strains. The following parameters (with 95% CI) were to be calculated for each treatment group: •Geometric Mean Titre (GMT) at post-vaccination timepoint •Seroconversion rate (SCR), defined as the proportion of subjects with either a pre-vaccination HI titer or = 1:40, or a pre-vaccination titer > or = 1:10 and a minimum 4-fold increase at post-vaccination titer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Serum anti-HA antibody titer against each of the three vaccine strains. The following parameters (with 95% CI) were to be calculated for each treatment group: • Seroprotection rate (SPR) at pre and post-vaccination time-points • Seroconversion factor (SCF) 2) Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms 3) Percentage, intensity and relationship to vaccination of unsolicited symptoms 4) Occurrence of serious adverse events and new onset of chronic illnesses 5) Occurrence of rare serious events (an occurrence rate of 1/300);Timepoint(s) of evaluation of this end point: For 1): At pre-vaccination (Day 0) and at post-vaccination (Day 28 for primed or Day 56 for unprimed subjects) For 2): During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination For 3): During the 28-day follow-up period(s) after each vaccination For 4): During the entire study period For 5): During the entire study period | — |
Countries
Hong Kong, Mexico, Taiwan, Thailand, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed