Pandemic Influenza MedDRA version: 18.0 Level: LLT Classification code 10070436 Term: H5N1 influenza System Organ Class: 100000004862
Conditions
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 following inclusion criteria in the “all subjects” section and ALL of the inclusion criteria in the respective section for their underlying health status: All subjects 1. Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; 2. Individuals with a projected life expectancy of 12 months or longer; 3. Individuals who are able to comply with all study procedures and requirements; Subjects with underlying medical conditions only 4. Individuals with at least one of the following medical conditions: a. Documented underlying chronic respiratory medical condition: Chronic pulmonary disease. Classification of severity of COPD will be based on utilization of the 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, including evaluation of force expiratory volume (FEV1) within 3 months prior to enrollment. Eligible subjects must be classified with either GOLD 2 (moderate) or GOLD 3 (severe) impairment for enrollment (GOLD, 2013), b. Underlying cardiovascular medical condition: i. Documented myocardial infarction (confirmed by at least two of the following: symptoms, ECG changes, biochemical markers, (echocardiogram finding) ii. Documented congestive heart failure with New York Heart Association (NYHA) functional classification Class II or III, c. Documented peripheral vascular disease including Rutherford symptom score of 2 (moderate claudication) or higher, d. Documented diabetes mellitus with hemoglobin A1c =7 to =65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: All subjects 1. Individuals who are not able to follow all the required study procedures for the whole period of the study; 2. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject’s ability to participate in the study;Note: Concomitant participation in an observational study (not involving drugs, vaccines, or medical devices) is acceptable; 3. Individuals who are hospitalized or residing in a nursing care facility; 4. Individuals who are planning to change their home address due to relocation during the course of the trial and may become unavailable for follow-up; 5. Individuals with any fatal prognosis of an underlying medical condition (<12 months life expectancy); 6. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome; 7. Individuals with known human immunodeficiency virus (HIV) infection or HIVrelated disease; 8. Individuals who have received other nonstudy vaccines within 7 days of either day 1 or day 22 vaccination; 9. Individuals who have ever received an H5N1 vaccine; 10. Individuals who are receiving another investigational product within 30 days prior to day 1 or before completion of the safety Follow-up Period in another study and who are unwilling to refuse participation in another clinical study at any time during the conduct of this study 11. Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the following: influenza viral proteins, excipient(s) of the study or reference vaccine (see section 5.0), eggs (including ovalbumin), or chicken protein; 12. Individuals with history of (or current) drug or alcohol abuse that, in the Investigator’s opinion, would interfere with the safety of the subject or the evaluation of study objectives; 13. Individuals who will undergo surgery planned during the study period that, in the Investigator’s opinion, would interfere with the study visit schedule; 14. Individual who is a member of the research staff or has relatives who are members of the research staff (research staff are individuals with direct contact with study subjects or study site personnel who have access to any study document containing subject information, including receptionists, persons scheduling appointments or making screening calls, regulatory specialists, or laboratory technicians). Hospital personnel, health care professionals, and their relatives who are not involved in this clinical study are allowed for inclusion; 15. Female subjects of childbearing potential who are sexually active and have not used for at least 2 months prior to study entry one or more of the following acceptable contraceptive methods: - Hormonal contraceptive (oral, injection, transdermal patch, implant, cervical ring), - Barrier (condom with or without spermicide or diaphragm with spermicide) each and every time during intercourse, - Intrauterine device, - Monogamous relationship with vasectomized partner (partner must have been vasectomized for at least 6 months prior to the subject’s study entry), - Abstinence, if not sexually active, at least 2 months before the study entry and at least 2 months after the study entry (through day 60 of study participation); 16. Female subjects of childbearing potential who have a positive pregnancy test prior to study entry, who are nursing (breastfeeding), or who are sex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Immunogenicity Objective: To evaluate homologous antibody responses to aH5N1 vaccine 3 weeks after second vaccination (day 43) according to CHMP immunogenicity criteria1 in adult (18 through 60 years of age) and elderly (=61 years of age) subjects who are healthy or with underlying medical condition, as measured by hemagglutination inhibition (HI) assay. Primary Safety Objective: To evaluate in pooled age groups 18 years of age and older solicited and unsolicited adverse events in adults and elderly subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.;Secondary Objective: Secondary Immunogenicity Objectives: To evaluate homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition, as measured by HI assay. To evaluate homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition, as measured by serial radial haemolysis (SRH) assay. ;Primary end point(s): Primary Immunogenicity Endpoint: ? Percentage of subjects achieving seroconversion (defined as HI =1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer =1:10]) on day 43 ? Geometric mean ratios (GMRs) on day 43/day 1, as determined by HI assay ? Percentage of subjects with an HI titer =1:40 on day 43 Primary Safety Endpoint: ? Percentages of subjects with solicited local, solicited systemic, and other AEs that occur within 7 days following each vaccination and calculated for 4 time intervals after vaccination: 30 minutes, 6 hours through 3 days, 4 days through 7 days, and 6 hours through 7 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Immunogenicity Endpoints: ? Geometric mean titers (GMTs) at the following time points: day 1, day 22 (3 weeks after the first vaccination), day 43 (3 weeks after the second vaccination) as determined by HI and SRH ? GMRs, calculated as follows: day 22/day 1 as determined by HI and day 22/day 1, day 43/day 1 as determined by SRH ? Percentage of subjects achieving seroconversion (defined as HI =1:40 for subjects who were seronegative at baseline [day 1 HI titer 3.997 mm2]) on days 22, 43 ? Percentage of subjects with geometric mean area =25 mm2 on days 1, 22, 43 ;Timepoint(s) of evaluation of this end point: three weeks after first vaccination (day 22) by HI three weeks after first and second vaccinations (day 22 and day 43) by SRH | — |
Countries
Germany
Contacts
Public ContactGlobal Clinical Operations Lead
Novartis Influenza Vaccines
Outcome results
None listed