Influenza
Conditions
Interventions
Trade Name: Fluad
Pharmaceutical Form: Suspension for injection
Trade Name: Fluzone
Pharmaceutical Form: Suspension for injection
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Individuals of >6 months through =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Each subject must not have: 1. Progressive, unstable or uncontrolled clinical conditions. 2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 3. History of progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome. 4. Surgery planned during the study period that in the Investigator’s opinion would interfere with the study visits schedule. 5. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 6. Any fatal prognosis of an underlying medical condition (<12 month life expectancy). 7. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 8. Abnormal function of the immune system resulting from: a. Clinical conditions. b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 9. Received immunoglobulins or any blood products within 180 days prior to informed consent. 10. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. 11. Study personnel as an immediate family or household member. 12. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 13. Received any influenza vaccine (licensed or investigational) or with laboratory confirmed influenza within 6 months prior enrollment. 14. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the safety of aTIV and TIV vaccines administered to healthy subjects 6 to 330 in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. 3. If non-inferiority will be established, to evaluate the GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, using margins greater than the non-inferiority cutoff of 0.67.;Primary end point(s): 1. Percentage of subjects reporting solicited local and systemic AEs from day 1 to day 7 following each vaccination; 2. Percentage of subjects reporting all unsolicited AEs from day 1 to day 50 (vaccine naïve subjects), from day 1 to day 22 (non-naïve subjects); 3. Percentage of subjects reporting medically attended AEs (MAAEs), AEs leading to study withdrawal and SAEs from day 1 to day 50 (naïve subjects), from day 1 to day 22 (non-naïve subjects). 4. GMTs on day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects), as applicable.;Timepoint(s) of evaluation of this end point: 1. from day 1 to day 7 following each vaccination; 2. from day 1 to day 50 (vaccine naïve subjects), from day 1 to day 22 (non-naïve subjects); 3. from day 1 to day 50 (naïve subjects), from day 1 to day 22 (non-naïve subjects). 4. day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects), | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of subjects achieving seroconversion defined as: HI = 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer =10, on day 22 (non-naïve subjects) or day 50 (naïve subjects), as applicable; 2. Day 22/day 1 (non-naïve subjects) or day 50/day 1 (naïve subjects) GMRs of HI, as applicable; 3. Percentage of subjects with a HI titer = 40, =110 and =330 on day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects), as applicable.;Timepoint(s) of evaluation of this end point: 1. day 22 (non-naïve subjects) or day 50 (naïve subjects); 2. day 1 and day 22 (non-naïve subjects) or day 50 (naïve subjects); 3. day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects). | — |
Countries
Mexico
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services AG
Outcome results
None listed