Influenza (vaccine trial) MedDRA version: 8.1 Level: PT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: FLUAD
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutin strain A/New Caledonia/20/99-like (H1N1)
Concentration unit: µg/ml microgram(s)/millilitre
Concentrati
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy children of 6 months to 36 months of age, whose parents have given written informed consent prior to the study entry, and in good health as determined by: a. medical history, b. physical examination, c. clinical judgment of the investigator. 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: 1) 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). 2) 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) 3) Fever within the 7 days before enrollment 4) 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 5) Known or suspected impairment/alteration of immune function, for example, resulting from: a. receipt of immunosuppressive 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of one 0.25 mL intramuscular (IM) injection of FLUAD influenza vaccine and that of two 0.25 mL IM injections of the conventional influenza vaccine Vaxigrip, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test.;Primary end point(s): To evaluate the immunogenicity of one 0.25 mL intramuscular (IM) injection of FLUAD influenza vaccine and that of two 0.25 mL IM injections of the conventional influenza vaccine Vaxigrip, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test.;Secondary Objective: To evaluate the immunogenicity of two 0.25 mL IM injections of FLUAD influenza vaccine with that of two 0.25 mL IM injections of the conventional influenza vaccine Vaxigrip: -in terms of post-immunization GMTs, as measured by HI test, -in terms of seroprotection, and seroconversion or significant increase, as measured by HI test. -in terms of seroprotection, and seroconversion or significant increase, as measured by HI test. - in terms of post-immunization GMTs, seroprotection, and seroconversion or significant increase, as measured by HI test. | — |
Countries
Finland
Outcome results
None listed