E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against influenza of children previously vaccinated with GSK's adjuvanted H1N1 vaccine (Pandemrix) at the age of 6 months - 9 years. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate HI immune response against the H1N1 strain 28 days following vaccination with the first dose of trivalent inactivated influenza virus (TIV) vaccine (Fluarix) in subjects previously vaccinated with 2 doses of H1N1 adjuvanted vaccine (Pandemrix). |
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E.2.2 | Secondary objectives of the trial |
-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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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 relationship to additional vaccination during the entire study period. •For the humoral immune response in terms of HI antibodies against all TIV strains in all subjects and per age strata, the following parameters will be calculated with 95% CIs: Observed variable: -HI antibodies on Day 0, Day 28*, and Month 6**. Derived variables: -GMTs and seropositivity rates on Day 0, Day 28*, and Month 6**; -SCRs on Day 28*, and Month 6**; -SPRs on Day 0, Day 28*, and Month 6**; -MGIs on Day 28*, and Month 6**. •For the humoral immune response in terms of neutralising antibodies against all TIV strains, the following parameters will be calculated with 95% CI (in a subset of subjects): Observed variable: -Serum neutralising antibody titres on Day 0, Day 28*, and Month 6**. -Derived variables: -GMTs of serum neutralising antibody titres and seropositivity rates; -SCRs. *TIV Group only **only H1N1 in the Control group
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |