influenza MedDRA version: 12.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: Fluad
Pharmaceutical Form: Suspension for injection
Trade Name: Agrippal
Pharmaceutical Form: Suspension for injection
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of 6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol can be given after the active trial phase (3 weeks after last vaccination) has been concluded; 2. Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study; 3. Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable); 4. Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 6 days prior to study start; 5. Experience a body temperature ?38.0°C within the 3 days before enrollment. 6. Children with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study 7. Children with known or suspected impairment/alteration of immune function, for example resulting from: a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800µg/day or fluticasone 750µg/day) within 60 days prior to Visit 1, b. receipt of immunostimulants within 60 days prior to Visit 1, c. receipt of parenteral immunoglobulin preparartion, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study, d. known HIV infection or HIV-related disease; 8. Children with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time 9. History of hypersensitivity to any component of the study medication or chemically related substances; 10. History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component; 11. Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1; 12. History of neurological disorder or seizures (febrile seizures allowed). 13. Ever received any influenza vaccine. 14. Major surgery planned during the study period. 15. Children hospitalized 16. Children with any fatal prognosis of an underlying medical condition (<12 month life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the cell mediated immune (CMI) responses to two 0.25 mL IM injections of Fluad or to two 0.25 mL IM injections of Agrippal as determined by the quality and quantity of the antigen-specific T- cells responses after in-vitro restimulation of peripheral blood mononuclear cells in previously unvaccinated healthy children aged 6 to <36 months. To evaluate the safety and tolerability of two 0.25 mL IM injections of Fluad or Agrippal in previously unvaccinated healthy children aged 6 to <36 months.;Secondary Objective: To evaluate the immune responses to two 0.25 mL IM injections of Fluad or Agrippal according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to <36 months for all three strains. Exploratory Objective If enough plasma is available, evaluation of the immune responses to two 0.25 mL IM injections of Fluad or Agrippal according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test from previously unvaccinated healthy children aged 6 to <36 months for heterologous strains. To evaluate descriptively and quantitatively the relationship and correlation between cell mediated and humoral immunity against influenza viruses, as determined from the primary and secondary objectives. ;Primary end point(s): The measures of CMI for the primary objective are collected for all evaluable subjects and are determined by Intracellular staining/FACS (ICS/FACS) after in vitro restimulation of PBMC with vaccine antigens More precisely, ICS/FACS will determine: - Frequency of CD4 T cells specific for the antigen/s present in the vaccine. - Qualitative cytokine profile of the antigen specific CD4 T cells. | — |
Countries
Germany
Outcome results
None listed