A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Non-Elderly Adults 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: NCT01759654
Recruitment Status : Unknown
Verified December 2012 by Adimmune Corporation.
Recruitment status was:  Recruiting
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
Adimmune Corporation

Brief Summary:
This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in non-elderly and elderly subjects. All participates will receive one dose of vaccine (0.5 ml) by intramuscular injection into the upper arm. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events for 28 days, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 28 days after vaccination. Anti-hemagglutinin (HA) antibody titers will be determined using the WHO hemagglutination inhibition reference technique. The central laboratory who is responsible for antibody titrations will not be aware of the background of blood samples (e.g., pre- or post-serum), it is also called observer-blinded. All participates will be followed, either by clinical visit or by telephone contact, for 8 weeks after the vaccination for safety reasons.

Condition or disease Intervention/treatment Phase
Influenza Biological: AdimFlu-V Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: AdimFlu-V Biological: AdimFlu-V

Primary Outcome Measures :
  1. The primary objective is to evaluate the immune response (i.e. HAI titer) in subjects after administration of influenza vaccine for 2012-2013 season. [ Time Frame: Change from baseline for HAI titer at 21 days post immunization ]
    Serum samples will be obtained prior to vaccination, and 3 weeks post vaccination. Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory.

Secondary Outcome Measures :
  1. Number of participants reporting reactogenicity events [ Time Frame: up to 7 days after vaccination ]
    Reactogenicity events are pre-specified adverse events systematically recorded on diary cards (a grid of check boxes for each event and each day) during the immediate post-vaccination period by all participants. In general, reactogenicity events will be recorded for 7 days after vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection including fever (≥38°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions will also be evaluated that include soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.

  2. Number of participants reporting serious and non-serious adverse events [ Time Frame: Up to 8 weeks after vaccination. ]
    In regard to the long term safety of the study vaccine, the significant and/or serious/non-serious adverse event(s) will be recorded during the 8 weeks follow up after vaccination.

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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:

  1. Males and non-pregnant females and aged no less than 18 years;
  2. Willing and able to adhere to visit schedules and all study requirements;
  3. Subjects are willing to provide the signed study-specific informed consent.

Exclusion Criteria:

  1. Subject or his/her family is employed by the participated hospital;
  2. Subjects received influenza vaccine within the previous 6 months;
  3. History of hypersensitivity to eggs or hen's protein, polymyxin B, or neomycin, or similar pharmacological effects to study vaccine;
  4. Personal or family history of Guillain-Barré Syndrome;
  5. An acute febrile illness within 1 week prior to vaccination;
  6. Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
  7. Subjects with influenza-like illness as defined by the presence of fever (temperature no less than 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;
  8. Female subjects who are pregnant, lactating or likely to become pregnant during the study; women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, intrauterine device (IUD), barrier device or abstinence) throughout the study;
  9. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before study vaccination;
  10. Immunodeficiency, or under immunosuppressive treatment;
  11. Receipt of live virus vaccine within 1 month prior to study vaccination or expected receipt within 1 month of study vaccination; receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt within 1 month of study vaccination;
  12. Receipt of any blood products, including immunoglobulin in the prior 3 months;
  13. Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
  14. Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

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): NCT01759654

Contact: Llu Fan

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Kuo-Ching Huang, MD         
Sponsors and Collaborators
Adimmune Corporation

Responsible Party: Adimmune Corporation Identifier: NCT01759654     History of Changes
Other Study ID Numbers: FLUV12T13A
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012

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