Healthy pediatric population from 3-17 years
Conditions
Interventions
Trade Name: Optaflu
Product Code: V58
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/Solomon Islands/3/2006-like (H1N1) Influenza Strain
Concentration unit: µg microgram(s)
Conce
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs; 2. In good health as determined by: a. medical history, b. physical examination, c. clinical judgment of the Investigator; 3. Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any serious disease, such as: a. cancer, b. autoimmune disease (including rheumatoid arthritis), c. diabetes mellitus, d. chronic pulmonary disease, e. acute or progressive hepatic disease, f. acute or progressive renal disease; 2. History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials; 3. Known or suspected impairment/alteration of immune function, including: a. use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1, b. cancer chemotherapy, c. receipt of immunostimulants within 60 days prior to Visit 1, d. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study, e. known HIV infection or HIV-related disease; 4. History of Guillain-Barré syndrome; 5. Bleeding diathesis; 6. Surgery planned during the study period; 7. Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study; 8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1; 9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1; 10. For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season; 11. Receipt of an influenza vaccine within 6 months prior to Visit 1; 12. Experienced a temperature ?38.0°C [?100.4?F]) and/or any acute illness within 3 days prior to Visit 1; 13. Pregnant or nursing mother; 14. Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control; 15. Research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct study subject contact, indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.; 16. Any condition, which in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Co-Primary: To demonstrate non-inferiority of the post-vaccination (Day 50) hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza vaccine to the corresponding GMT of the egg-derived influenza vaccine for all three strains after two doses administered four weeks apart to a subset of children 3 to 8 years of age (Cohort 3, immunogenicity subset). To demonstrate non-inferiority of the percentages of subjects achieving seroconversion or significant increase in antibody titer at Day 50 following administration of the cell culture-derived influenza vaccine to the corresponding percentages of subjects following administration of the egg-derived influenza vaccine for all three strains after two doses administered four weeks apart to a subset of children 3 to 8 years of age (Cohort 3, immunogenicity subset). ;Secondary Objective: To evaluate immunogenicity, measured by seroprotection and by percentage of subjects achieving seroconversion or significant increase, of: - one dose of either the cell culture-derived or the egg-derived influenza vaccine administered to children and adolescents 9 to 17 years of age (Cohort 1) - two doses of either the cell culture-derived or the egg-derived influenza vaccine, administered 4 weeks apart to a subset of children 3 to 8 years of age (Cohort 3, immunogenicity subset) Safety Objectives To evaluate safety and tolerability of one dose of either the cell culture-derived or the egg-derived influenza vaccine in children and adolescents 9 to 17 years of age (Cohorts 1 and 2) and of two doses of either the cell culture-derived or the egg-derived influenza vaccine, administered four weeks apart to children 3 to 8 years of age (Cohort 3). ;Primary end point(s): Non-inferiority of GMTs in Cohort 3, immunogenicity subset: For the demonstration of non-inferiority of the cell culture-derived influenza vaccine when compared to the egg-derived vaccine in terms of post-vaccination GMTs | — |
Countries
Finland, Hungary, Italy, Lithuania
Outcome results
None listed