Prophylaxis of influenza
Conditions
Interventions
Trade Name: FLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur.
Product Name: FLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur.
Product Code: FLUVIRIN®
Pharmaceutical
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of one 0.5mL and two 0.5mL intramuscular (IM) injections of FLUVIRIN® and Agrippal® administered 4 weeks apart;Secondary Objective: 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;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. | — |
Countries
United Kingdom
Outcome results
None listed