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 a single 0.25mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 35 months. ·To evaluate the immunogenicity of a single 0.5mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 48 months. ·To overall evaluate the immunogenicity of a single 0.25mL or 0.5mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 48 months.
|
|
E.2.2 | Secondary objectives of the trial |
·To compare the overall immunogenicity of a single 0.25mL or 0.5mL IM injection of FLUAD vs. Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), with regard to all the three strains, as measured by HI test in healthy children aged up to 48 months. ·To evaluate the immunogenicity of a single 0.25mL IM injection of FLUAD or Vaxigrip influenza vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test in healthy children aged up to 35 months. ·To evaluate the immunogenicity of a single 0.5mL IM injection of FLUAD or Vaxigrip influenza vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test in healthy children aged up to 48 months. ·To evaluate the immunogenicity induced by FLUAD or Vaxigrip against strains different from those included in the study vaccine formulation. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-children up to 48 months of age, who received both doses of one of the two study vaccines (FLUAD or Vaxigrip) in the previous V70P2 trial, whose parents/legal guardians have given written informed consent prior to study entry, -Children in good health as determined by: a.medical history, b.physical examination, c.clinical judgment of the investigator. |
|
E.4 | Principal exclusion criteria |
-Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable); -Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); -Fever (defined as axillary temperature ≥ 38.0°C/rectal temperature ≥ 38.5°C) within the 7 days before enrolment; -Any serious disease including, for example: a.cancer, b.autoimmune disease (including rheumatoid arthritis), c.diabetes mellitus, d.chronic pulmonary disease, e.acute or progressive hepatic disease, f.acute or progressive renal disease; -Known or suspected impairment/alteration of immune function, for example, resulting from: a.receipt of immunosuppressive therapy (corticosteroid - except topical or inhaled steroids - or cancer chemotherapy), b.receipt of immunostimulants, c.receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, d.high risk for developing an immunocompromising disease; -Bleeding diathesis; -History of hypersensitivity to any component of the study medication or chemically related substances; -History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component; -Laboratory confirmed influenza disease in the past 6 months; -Surgery planned during the study period; -Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 4 weeks after last vaccination in the respective season) has been concluded; -Participation to another trial of an investigational agent within 90 days of enrolment; -Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
·To overall evaluate the immunogenicity of a single 0.25mL or 0.5mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI test in healthy children aged up to 48 months. ·To evaluate the safety and tolerability of a single 0.25mL or 0.5mL IM injection of FLUAD or Vaxigrip influenza vaccines in healthy children aged up to 48 months |
|
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 | No |
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 |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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
|
The end of trial corresponds to the study termination visit (Extension study day 181 ± 4) |
|
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 | 7 |
E.8.9.1 | In the Member State concerned days | |