Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

Adimmune

Status

Completed

Conditions

Influenza

Treatments

Biological: elderly aged over 60

Biological: non-elderly aged between 18 and 60

Study type

Interventional

Funder types

Industry

Identifiers

NCT01411358

FLU11T12A

Details and patient eligibility

About

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).

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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
Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
Receipt of any blood products, including immunoglobulin in the prior 3 months;
Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine