seasonal influenza vaccine MedDRA version: 9.1 Level: PT Classification code 10022000
Conditions
Interventions
Trade Name: INFLEXAL V
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number
Sponsors
CRUCELL SWITZERLAND AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female children • Aged =6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute respiratory infection or other acute disease • Acute febrile illness (=38.0 ?C) •Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus •Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus) •Known hypersensitivity to any vaccine component •Known history of egg protein allergy or severe atopy •Known blood coagulation disorder •Chronic (longer than 14 days) administration of immunosuppressants or other immune- modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent for =14 days (inhaled or topical steroids are allowed) • Known immunodeficiency (including leukemia, cancer, HIV seropositivity) • Investigational medicinal product received in the past 3 months (90 days) •Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) •Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period • Participation in another clinical trial • Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee • Suspected non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re- registration of the seasonal influenza vaccine in adults (aged =18 - =60 years) as reference;Secondary Objective: To assess the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regimen of Inflexal V in unprimed children separately for the ages 6 - <21 and 21 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged =18 - =60 years) as reference To assess the local and systemic safety and tolerability of the 2 Inflexal V dosing schemes;Primary end point(s): • Seroprotection rate, defined as proportion of subjects with HI antibody titer =1:40 • Seroconversion rate, defined as proportion of subjects with =4-fold increase in HI antibody titer and with a titer of =1:40 • GMT of HI antibodies and fold-increase in GMT | — |
Countries
Italy
Outcome results
None listed