no medical, condition: healthy,
Conditions
Interventions
Trade Name: Fluad
Pharmaceutical Form: Suspension for injection
Other descriptive name: A/Brisbane/59/2007 (H1N1) - like influenza virus strain
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children of 6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. 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. 3 weeks after last vaccination in the respective season) has been concluded. 2) Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start. 3) Administration of any other investigational agent (other than the study vaccine) throughout the entire study period. 4) 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). 5) Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) 6) Fever (defined as axillary temperature = 38°C/rectal temperature = 38.5°C) within the 2 days before enrollment 7) 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 8) 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 9) Bleeding diathesis 10) History of hypersensitivity to any component of the study medication or chemically related substances 11) History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component 12) Laboratory confirmed influenza disease in the past 6 months 13) History of neurological disorder or seizures (febrile seizures allowed) 14) Ever received any influenza vaccine 15) Major surgery planned during the study period 16) Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: - To demonstrate the safety and tolerability of one or two 0.25mL IM doses of FLUAD in unprimed children aged 6 to <36 months, compared with Agrippal S1 and/or with Influsplit SSW (flu vaccine control), in terms of any solicited local and systemic reactions (combined) reported within 7 days after any vaccination.;Secondary Objective: Safety: • To demonstrate the safety and tolerability of one or two 0.25mL or 0.5mL IM doses of FLUAD in unprimed children aged 6 to <72 months, compared to flu vaccine control, in terms of any solicited local and systemic reactions (combined) reported within 7 days after any vaccination. For the following end points, vaccine’s safety and tolerability will be evaluated both in unprimed children aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months). • To evaluate the safety and tolerability of one or two 0.25mL or 0.5mL IM doses of FLUAD compared to flu vaccine control, in terms of unsolicited adverse events reported after any vaccination. • To evaluate the safety and tolerability of one or two 0.25mL or 0.5mL IM doses of FLUAD, compared to non-flu vaccine control, in terms of solicited local and systemic reactions and unsolicited adverse events reported after any vaccination. Absolute efficacy: ;Primary end point(s): Serum samples will be assessed by means of strain-specific HI tests. The HI tests against A/H1N1, A/H3N2 and B will be performed by Clinical Serology, Novartis Vaccines, Marburg, Germany. The primary measure of immunogenicity is the geometric mean titer (GMT) at study day 50 (3 weeks after the second vaccination), as measured by Hemagglutination Inhibition (HI) test, and possibly by other functional assays. The immunogenicity will also be assessed by the measurement of strain-specific HI tests in terms of: - GMTs at study day 1, study day 29, and study day 181 - Study day 29/study day 1, study day 50/study day 1, and study day 181/study day 1 geometric mean titer | — |
Countries
Belgium, Finland, Germany, Hungary, Italy
Outcome results
None listed