volunteers at high risk for influenza-related complications (protection against influenza) MedDRA version: 14.1 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Optaflu
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: A/ (H1N1)-LIKE VIRUS ANTIGEN
Other descriptive name: A/ (H1N1)-LIKE VIRUS ANTIGEN
Concentra
Sponsors
Novartis Vaccines & Diagnostics AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 3 through 17 years of age at the time of enrollment who are at high risk for influenza-related complications including subjects with confirmed documented medical history of any of the following criteria, as per the WHO recommendations (Weekly Epidemiological Record. 2005;33(80):279-87). 2. Individuals with parents/legal guardians who have given written consent after the nature of the study has been explained according to local regulatory requirements (and where applicable according to local regulations, informed assent for subjects above the specified age). 3. Subjects who, or subjects whose parent/legal guardian, are able to comply with all study procedures and requirements Are the trial subjects under 18? yes Number of subjects for this age range: 504 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. Individuals whose parent(s)/legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 2. Individuals with a history of Guillain-Barré syndrome. 3. Individuals with any fatal prognosis of an underlying medical condition (<12 month life expectancy). 4. Individuals hospitalized at the time of enrolment. 5. Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components. 6. Children of research staff involved with the clinical study at this institution or who are otherwise related to research staff or have household members who are research staff associated with the investigator. 7. Individuals with acute disease and/or fever (ie, body temperature measurement =38°C [=100.4°F]) within 3 days prior to vaccination. 8. Individuals who have received vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment into this study. 9. Individuals who received another investigational agent within 30 days prior to enrollment or before completion of the safety follow-up period or who are unwilling to refuse to participate in another clinical study through the duration of this study. 10. Individuals who have been immunized with any influenza vaccine (licensed or investigational) within 6 months prior to enrolment or with planned influenza vaccination (other than study vaccine) during the study. 11. Individuals who have been given an antipyretic in the past 24 hours prior to vaccination. 12. Individuals with any other condition which, in the opinion of the investigator, prevents the subject’s participation in the study. 13. Individuals whose parent(s)/legal guardian(s) are unwilling to be contacted by the phone for the safety phone calls or active influenza surveillance. 14. Individuals who are pregnant or breastfeeding. 15. If 9-17 years of age and female, “of childbearing potential”, sexually active, and has not used any of the “acceptable contraceptive methods” for at least 2 months prior to study entry and refuses to use an acceptable contraceptive method through the end of the study. 16. Female subjects of childbearing potential with a positive or indeterminate pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of 1 or 2 intramuscular doses (administered 4 weeks apart) of either the cell culture-derived influenza vaccine TIVc or the egg-derived influenza vaccine TIV in children and adolescents 3 to <18 years of age at risk for influenza-related complications.;Secondary Objective: This study has no secondary objectives.;Primary end point(s): The primary endpoint for this study is safety: proportion of subjects reporting solicited AEs (including local and systemic and other solicited AEs); proportion of subjects reporting unsolicited AEs; proportion of subjects reporting SAEs, new onset of chronic diseases, medically attended AEs, and AEs leading to vaccine/study withdrawal;Timepoint(s) of evaluation of this end point: - Solicited adverse events: day of vaccination and the following 6 days (day 1 to day 7 and day 29 to day 35–the latter only for not previously vaccinated subjects); - Unsolicited adverse events: AEs occurring for approximately 3 to 4 weeks after each vaccination (ie, from day 1 to day 28; and from day 29 to day 49–the latter only for not previously vaccinated subjects); - SAEs, new onset of chronic diseases, medically attended AEs, and AEs leading to vaccine/study withdrawal: up to day 213 for “not previously vaccinated” subjects 3 to <9 years or up to day 183 for all other subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no secondary endpoints in this study;Timepoint(s) of evaluation of this end point: There are no secondary endpoints in this study | — |
Countries
Italy, Spain
Contacts
Public ContactLaura Lulli
Novartis Vaccines and Diagnostics s.r.l.
Outcome results
None listed