Clinical Trial to evaluate the safety and antibody response of Agrippal flu vaccine for the 2012/2013 flu seaso

• Conditions: Clinical trial on healthy volunteers: prophylaxis of influenza, especially in subjects with a higher risk of flu associated complications.; MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-000063-24-IT
• Lead Sponsor: OVARTIS VACCINES AND DIAGNOSTICS S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-19
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

Individuals with behavioral or cognitive impairment or psychiatric disease. Individuals with any serious chronic or acute disease (in the judgment of the investigator). Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine. Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function. Individuals with known or suspected history of drug or alcohol abuse. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study. Individuals who within the past 6 months have: - had any laboratory confirmed seasonal or pandemic influenza disease; - received any seasonal or pandemic influenza vaccine. Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. Individuals that have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days of intended study vaccination. Individuals 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. Individuals who are part of study personnel or close family members conducting this study. BMI > 35 kg/m2. Females who are pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding). Females of childbearing potential4 who refuse to use an acceptable method of birth control for the whole duration of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified