Immunization against influenza of children previously vaccinated with GSK's adjuvanted H1N1 vaccine (Pandemrix) at the age of 6 months - 9 years.
Conditions
Interventions
Trade Name: Fluarix
Pharmaceutical Form: Suspension for injection
Current Sponsor code: A/California/7/2009 (H1N1)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equa
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects having previously been immunized with two 0.25 mL doses of Pandemrix (half dose), given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination. •Subjects having received the last dose of Pandemrix at least six months prior to study enrolment. •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, be available for telephone/fax contacts). •Written informed consent obtained from the parent(s)/LAR(s) of the subjects. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments). Are the trial subjects under 18? yes Number of subjects for this age range: 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: •Active participation in other clinical trials. •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. •Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. •Acute disease and/or fever at the time of enrolment: -Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study. •Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. •History of seizures (subjects who have had a single uncomplicated febrile convulsion in the past could be included) or progressive neurological disease. •Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine. •Child in care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -To evaluate safety and reactogenicity after each flu vaccination. -To assess the vaccine immune response in terms of HI (in all subjects) and neutralising antibodies (in a subset of subjects) against the 3 TIV strains, 28 days after the first dose of TIV vaccine overall and per age strata, in the TIV group. -To assess the immune status at the pre-vaccination time point in terms of HI (in all subjects) and neutralising (in a subset of subjects) antibodies against the 3 TIV strains per age strata in both study groups. -To assess the persistence of antibodies against the 3 TIV strains 6 months after the first TIV vaccine dose in terms of HI (in all subjects) and neutralising (in a subset of subjects) antibodies in the TIV group. -To assess the persistence of the immune response at the month 6 time point in terms of HI (in all subjects) and neutralising (in a subset of subjects) antibodies against the H1N1 strain in the control group. ;Primary end point(s): •For the humoral immune response in terms of HI antibodies against H1N1 (in all subjects in the TIV Group), the following parameters will be calculated with 95% CIs: Observed variable: -H1N1 HI antibody titres on Day 0 and Day 28. Derived variables: -GMTs and seropositivity rates on Day 0 and Day 28; -Seroprotection rates (SPRs) on Day 0 and Day 28. -Seroconversion rate (SCR) on Day 28 -Mean Geometric Increase (MGI) on Day 28 •Solicited local and general adverse events: -Occurrence, intensity and duration of each solicited local and general AE (any and grade 3) within 7 days (Day 0 – Day 6) after each vaccination. •Unsolicited adverse events: -Occurrence, intensity and relationship to vaccination of unsolicited AEs within 28 days (Day 0 – Day 27) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. •MAEs/AESIs/pIMDs/SAEs: and AEs of special interest -Occurrence of MAEs, AESIs/pIMDs, SAEs and AEs of special interest and relati | — |
Countries
Netherlands, Sweden
Outcome results
None listed