Influenza MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Aggripal
Pharmaceutical Form: Suspension for injection
Trade Name: Fluvirin
Pharmaceutical Form: Suspension for injection
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females aged 50 years and above, mentally competent, willing and able to give written informed consent prior to study entry and after the nature of the study has been explained according to local regulatory requirements. Individuals able to comply with all the study requirements. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1350
Exclusion criteria
Exclusion criteria: 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. Individuals with any progressive or severe neurologic disorder, seizure disorder or Guillan-Barré syndrome. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. Individuals who have received any seasonal or pandemic influenza vaccine or have had a laboratory confirmed seasonal or pandemic influenza disease within the past 6 months. Individuals 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. Individuals with suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy within 6 months or use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). Individuals who have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. Individuals with history of any anaphylactic adverse event and/or serious allergic adverse event following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate). Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. Receipt of non study vaccines (with the exception of post-exposure vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1. Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. Individuals who have received antibiotics within 6 days before vaccination. Individuals with body temperature (axillary temperature) =38 degrees Celsius (= 100.4° F) within the last 3 days of intended study vaccination. BMI > 35 kg/m2. Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures, for the whole duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry; Abstinence. Individuals who are part of study personnel or close family members conducting this study. Individuals with history of substance or alcohol abuse within the past 2 years. There may be instances when individuals meet all entr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of the post-vaccination (Day 22) hemagglutination inhibition (HI) geometric mean titers (GMTs) of AGRIFLU over the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults aged 50 years and above. To demonstrate non-inferiority of the percentages of subjects achieving seroconversion in antibody titers at Day 22 in the AGRIFLU group over the corresponding percentages of subjects in the comparator group for all three strains, in healthy adults aged 50 years and above. Safety Objectives To evaluate the safety and tolerability of of AGRIFLU or comparator vaccines in healthy adults aged 50 years and above. ;Secondary Objective: To evaluate immunogenicity in terms of percentage of subject with HI titer =1:40 and seroconversion rates and GMTs ratio of AGRIFLU or comparator, in healthy adults aged 50 years and above.;Timepoint(s) of evaluation of this end point: Day 1 and Day 22 - Primary Objective assessed at Day 22 Safety: • solicited adverse events: 30 minutes, Day 1-3 (without 30 min), Day 4-7 (without 30 min), Day 1-7 (without 30 min) after vaccination • unsolicited adverse events: Day 1-22 after vaccination ;Primary end point(s): The immunogenicity, for all 3 strains at Day 22, as determined by the HI assays, in terms of the ratio of the GMTs (GMT comparator/GMT AGRIFLU) and the difference between the seroconversion rates (Seroconversion comparator- Seroconversion AGRIFLU). Safety Endpoints The measures for assessing safety and tolerability are as follows: 1.Percentages of subjects with solicited local, solicited systemic and other adverse events as measured for 7 days following vaccination and calculated for four time intervals after vaccination: 30 minutes, Day 1-3 (without 30 min), Day 4-7 (without 30 min), Day 1-7 (without 30 min) 2.Percentages of subjects with any unsolicited AEs reported through 22 days after vaccination 3.Percentages of subjects reporting SAEs, AEs l | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The immunogenicity of each vaccine formulation (AGRIFLU and comparator) will be evaluated in terms of percentage of subject achieving a HI titer = 1:40, seroconversion, and geometric mean increase. ;Timepoint(s) of evaluation of this end point: Day 1 and Day 22 | — |
Countries
Czech Republic, Philippines, South Africa, Thailand
Contacts
Public ContactLucie Cerná Hlavatá
Novartis s.r.o.
Outcome results
None listed