Influenza
Conditions
Interventions
Trade Name: Agrippal
Product Name: Agrippal
Product Code: N/A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hemaglutinin strain A/New Caledonia/20/99(H1N1)
Concentration unit: µg/
Sponsors
Chiron S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) children of 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) participation to another trial of an investigational agent within 90 days of enrollment 2) any current acute infectious disease. Experience of a severe acute infectious disease in the month prior to study start or a mild acute infectious disease in the week prior to study start (untreated common cold is acceptable) 3) any severe acute respiratory disease and infections 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) 4) experienced fever (defined as axillary temperature = 38°C/rectal temperature = 38.5°C) within the past 7 days 5) 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 6) surgery planned during the study period 7) bleeding diathesis 8) history of hypersensitivity to any component of the study medication or chemically related substances 9) history of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component 10) known or suspected impairment/alteration of immune function, for example, resulting from: a. receipt of immunosuppressive therapy (any corticosteroid 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 11) laboratory confirmed influenza disease in the past 6 months 12) ever received any influenza vaccine 13) receipt of another vaccine or any investigational agent within 60 days prior to study start and throughout the entire study 14) 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: To evaluate the immunogenicity of two 0.25 intramuscular (IM) injections of Agrippal™ S1, Influvac™, and Vaxigrip™ administered 4 weeks apart.;Secondary Objective: To evaluate safety and tolerability of two 0.25 mL intramuscular injections of Agrippal™ S1, Influvac™, and Vaxigrip™ administered 4 weeks apart.;Primary end point(s): There are no standard CHMP criteria for assessing immunogenicity in the age groups under evaluation. Therefore, the immunogenicity of the three vaccines will be determined based on the evaluation pre- and post-immunization GMTs and of other immunogenicity measures, such as sero-protection rate and sero-conversion rate after vaccination. | — |
Countries
Finland
Outcome results
None listed