Influenza
Conditions
Interventions
Product Name: FCC Vaccine
Product Code: V58
Pharmaceutical Form: Suspension for injection
Trade Name: Agrippal S1
Product Name: Agrippal S1
Product Code: V71
Pharmaceutical Form: Suspension for injec
Sponsors
Chiron S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) 18 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) unwilling or unable to give written informed consent to participate in the study 2) participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study 3) currently experiencing an acute infectious disease 4) any serious disease, such as, for example: a. cancer, b. autoimmune disease (including rheumatoid arthritis), c. advanced arteriosclerotic disease or complicated diabetes mellitus, d. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy, e. acute or progressive hepatic disease, f. acute or progressive renal disease, g. congestive heart failure 5) surgery planned during the study period 6) bleeding diathesis 7) history of hypersensitivity to any component of the study medication or chemically related substances 8) history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component 9) known or suspected impairment/alteration of immune function, for example resulting from: a. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy), b. receipt of immunostimulants, c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study, d. high risk for developing an immunocompromising disease 10) history of drug or alcohol abuse 11) laboratory-confirmed influenza disease within 6 months prior to Visit 1 12) receipt of influenza vaccine within 6 months prior to Visit 1 13) receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination 14) any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature = 38°C) within 5 days prior to Visit 1 15) if female, pregnant or breastfeeding 16) if female, refusal to use a reliable contraceptive method during the three weeks following vaccination 17) planned relocation abroad during the study period 18) any condition that, 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 safety and tolerability of three lots of Chiron’s cell-derived influenza subunit vaccine as compared to a conventional egg-derived control vaccine, three weeks after a single 0.5 mL intramuscular (IM) injection. To collect additional safety data such as serious adverse events, adverse events necessitating a physician’s visit and/or resulting in premature subject’s withdrawal from study for approximately six months after vaccination to be included in an addendum to the final study report. ;Secondary Objective: To evaluate immunogenicity of the two vaccines and of each vaccine lot three weeks after a single 0.5 mL IM injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the current CHMP criteria (CPMP/BWP/214/96), as described below. For the HI test the measures of immunogenicity for each antigen are: - geometric mean titer (GMT) on study day 1 (Visit 1) and on study day 22 (Visit 2) - study day 22/study day 1 GMT ratio (GMR) - percentage of subjects achieving seroconversion* or significant increase in antibody titer** - percentage of subjects achieving an HI titer of = 40 on study day 1 and study day 22 Of Note: *Seroconversion is defined as negative pre-vaccination serum ( 40% - mean geometric increase > 2.5 - proportion of subjects achieving an HI titer = 40 should be > 70% All immunogenicity analyses will be repeated for the subset of subjects who are not protected pre-vaccination (< 40). | — |
Countries
Lithuania
Outcome results
None listed