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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01411358
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : July 12, 2012
Information provided by (Responsible Party):
Adimmune Corporation

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).

Condition or disease Intervention/treatment Phase
Influenza Biological: non-elderly aged between 18 and 60 Biological: elderly aged over 60 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects
Study Start Date : August 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: AdimFlu-S 2011-2012 Biological: non-elderly aged between 18 and 60
one dose of 0.5mL AdimFlu-S

Biological: elderly aged over 60
one dose of 0.5mL AdimFlu-S

Primary Outcome Measures :
  1. The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40. [ Time Frame: 3 weeks post vaccination ]
    Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01411358

National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
Adimmune Corporation
Principal Investigator: Gin-Hsiang Wu, MD National Cheng-Kung University Hospital

Responsible Party: Adimmune Corporation Identifier: NCT01411358     History of Changes
Other Study ID Numbers: FLU11T12A
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Adimmune Corporation:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases