E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 the immunogenicity of one 0.5mL and two 0.5mL intramuscular (IM) injections of FLUVIRIN® and Agrippal® administered 4 weeks apart |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of one 0.5mL and two 0.5mL intramuscular (IM) injection of FLUVIRIN® and Agrippal® administered 4 weeks apart |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects eligible for enrollment into this Phase IV trial are male and female paediatric subjects who are:
1) children of 3 years to <12 years of age, whose parents or legal guardians have given written informed consent prior to study entry
2) available for all the visits scheduled in the study
3) in good health as determined by: a. medical history, b. physical examination, c. clinical judgment of the investigator.
|
|
E.4 | Principal exclusion criteria |
Individuals are not to be enrolled into the study if:
1) they have any serious disease including, for example: a. cancer (except for benign or localized skin cancer not presently treated with chemotherapy) b. autoimmune disease (including rheumatoid arthritis), c. advanced arteriosclerotic disease or complicated diabetes mellitus, d. chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, e. acute or progressive hepatic disease, f. acute or progressive renal disease g. congestive heart failure
2) they have a history of any anaphylaxis, serious vaccine reactions, they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, thiomersal, neomycin or polymyxin or any other component of the vaccine
3) they have a known or suspected impairment/alteration of immune function, resulting from: a. receipt of immunosuppressive therapy (corticosteroids -except topical or inhaled steroids- or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study b. receipt of immunostimulants c. high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease)
4) receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
5) within the past six months they have had laboratory confirmed influenza disease
6) have ever received influenza vaccine
7) within the past four weeks they have received another vaccine or any investigational agent
8) within the past 7 days, they have experienced: · any acute disease; · infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
9) within the past 3 days they have experienced fever (defined as axillary temperature ≥38°C)
10) any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
11) participation to another clinical trial
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary measure of immunogenicity is the geometric mean titer (GMT) at study day 29 (four weeks after vaccination) for all subjects and study day 50 for subjects aged 3 - <9years, as measured by Hemagglutination Inhibition (HI) test.
The immunogenicity will also be assessed by the measurement of strain-specific HI tests in terms of: · percentage of subjects achieving an HI titer of ≥ 40 on study day 29 and 50 · study day 29/study day 1, study day 50/study day 29 geometric mean titer increase (GMR) · percentage of subjects achieving seroconversion* or significant increase in antibody titer** at study day 29 and 50
* Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥40. ** Significant increase in antibody titer is defined as at least a fourfold increase from non-negative (≥10) baseline.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |