- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411358
Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects
July 10, 2012 updated by: Adimmune Corporation
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan, Taiwan
- National Cheng Kung University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AdimFlu-S 2011-2012
|
one dose of 0.5mL AdimFlu-S
one dose of 0.5mL AdimFlu-S
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
3 weeks post vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gin-Hsiang Wu, MD, National Cheng-Kung University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 5, 2011
First Submitted That Met QC Criteria
August 5, 2011
First Posted (Estimate)
August 8, 2011
Study Record Updates
Last Update Posted (Estimate)
July 12, 2012
Last Update Submitted That Met QC Criteria
July 10, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLU11T12A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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