Clinical trial

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2011-2012, When Administered to Elderly Subjects

Name

V70_32S

Description

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.

Trial arms

Trial start

2011-05-01

Estimated PCD

2011-06-01

Trial end

2011-06-01

Status

Completed

Phase

Early phase I

Treatment

Seasonal Influenza Vaccine

This phase II is performed as a multicenter study in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .

Arms:

Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine

Size

Primary endpoint

Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD

day 22

Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD

day 22

Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD

day 22

Eligibility criteria

Key Inclusion Criteria: * Males and females volunteers of 65 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. * Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. Key Exclusion Criteria: * Individuals with any serious chronic or acute disease. * Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination. * Individuals with known or suspected 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 that in the investigator's opinion would interfere with the safety of the subject. * Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine. * 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 received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines. * Individuals who are part of study personnel or close family members conducting this study. * BMI \> 35 kg/m2.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ACTUAL'}}

Updated at

2023-04-28

1 organization

1 product

1 indication

Organization

Novartis Vaccines

Product

Seasonal Influenza Vaccine

Indication

Seasonal Influenza