Clinical trial on healthy volunteers: prophylaxis of influenza, especially in subjects with a higher risk of flu associated complications. MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AGRIPPAL S1*1SIR S/A 0,5ML 11-
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED)
CAS Number: NA
Other descriptive name: NA
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of a single intramuscular (IM) injection of Agrippal in adult and elderly subjects. in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at approximately 21 days post-immunization in adult and elderly subjects.;Secondary Objective: Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997).;Timepoint(s) of evaluation of this end point: 21 days after vaccination;Primary end point(s): Safety will be assessed in accordance with available safety data on influenza vaccines: -Local and systemic reactions will be assessed for 3 days post the day of vaccination - AEs Days 1 to 4. From Day 5 to study end AEs necessitating a physician’s visit or consultation and/or leading to premature study discontinuation and SAEs The following serological assessments will be considered for each strain in non-elderly adult subjects, aged between 18 and 60, and at least one of the assessments should meet the indicated requirements: - The proportion of subjects achieving seroconversion or significant increase in HI titer or SRH area >40% - Mean geometric increase >2.5 - The proportion of subjects achieving an HI titer =40 or SRH area =25 mm2 should be >70% The following serological assessments will be considered for each strain in elderly subjects, aged 60 years and over, and at least one of the assessments should meet the indicated requirements: - Proportion of seroconversion or significant increase in HI titer or SRH area >30% - Mean geometric increase >2.0 - The proportion of subjects achieving an HI titer =40 or SRH area =25 mm2 should be > 60% Circulating | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium, Italy
Contacts
Public ContactClinical Research Development SE
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Outcome results
None listed