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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01411358
First received: August 5, 2011
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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 Intervention
Influenza
Biological: non-elderly aged between 18 and 60
Biological: elderly aged over 60

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Adimmune Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).


Enrollment: 128
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411358

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

No publications provided

Responsible Party: Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01411358     History of Changes
Other Study ID Numbers: FLU11T12A
Study First Received: August 5, 2011
Last Updated: July 10, 2012
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Adimmune Corporation:
influenza
vaccine
immunogenicity

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

ClinicalTrials.gov processed this record on July 24, 2014