A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2011-2012, when Administered to Non-elderly Adult and Elderly Subjects. - V71_27S
- Conditions
- Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risk and elderly. Agrippal is a subunit inactivated influenza vaccine,purifeid,registered in Italy since 1986,recommended in the prevention of influenza in subjects from 6 months of age, in particular in subject at high risk for associated complicationsMedDRA version: 13.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2010-024400-98-IT
- Lead Sponsor
- OVARTIS VACCINES AND DIAGNOSTICS S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Males and females volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.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. 2.With any serious chronic or acute disease, including but not limited to:Medically significant Cancer (except for benign or localized skin cancer,cancer in remission for =10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment; Medically significant advanced congestive heart failure(ie. NYHA class III and IV,COPD;Autoimmune disease (including rheumatoid arthritis, except for Hashimoto`s thyroiditis that has been clinically stable for = 5 years); Diabetes mellitus type I; Poorly controlled diabetes mellitus type II;Advanced arteriosclerotic disease;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome);Acute,progressive hepatic disease;Acute,progressive renal disease;Severe neurological (es. Guillain–Barre` syndrome)or psychiatric disorder;Severe asthma. 3.With history of any anaphylactic reaction and/or serious allergic reaction following a vaccination,proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein,feathers,influenza viral protein, kanamycin and neomycin sulphate). 4.With known or suspected(or have high risk of developing)impairment/alteration of immune function (excluding that normally associated with advanced age,resulting, from:receipt of immunosuppressive therapy(any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;receipt of immunostimulants;receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;suspected or known HIV infection or HIV-related disease. 5.With known or suspected history of drug or alcohol abuse. 6.With a bleeding diathesis or conditions associated with prolonged bleeding time would interfere with the safety of the subject. 7.Female who are pregnant or nursing, 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,barrier, intrauterine device, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry. 8.Individuals not able to comprehend and to follow all required study procedures for the whole period. 9.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. 10.Individuals Within the past 6 months,they had any seasonal or pandemic laboratory confirmed influenza disease;received any seasonal or pandemic influenza vaccine. 11.With any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. 12.Individuals that have experienced fever(i.e., axillary temperature = 38?C) within the last 3 days of intended study vaccination. 13.participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 14.Who
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method