Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects

Adimmune Corporation1 site in 1 country128 target enrollmentAugust 2011

ConditionsInfluenza

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Influenza
Sponsor: Adimmune Corporation
Enrollment: 128
Locations: 1
Primary Endpoint: The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

March 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Adimmune Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or non-pregnant females and aged ≥ 18 years;
•Willing and able to adhere to visit schedules and all study requirements;
•Subjects read and signed the study-specific informed consent.

Exclusion Criteria

•Subject or his/her family is employed by the participated hospital;
•Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
•History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication
•Personal or family history of Guillain-Barré Syndrome
•An acute febrile illness within 1 week prior to vaccination;
•Current upper respiratory illness, including the common cold or nasal congestion within 72 hours
•Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough
•Female subjects who are pregnant during the study
•Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
•Immunodeficiency, or under immunosuppressive treatment