- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755364
A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Healthy Subjects Aged Over 3 Years Old to 18 Years Old
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital at Linkuo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Boys or non-pregnant girls and aged ≥ 3 through < 18 years old on the day of first vaccination;
- Subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
- Subject must be in good physical health on the basis of medical history, physical examination;
- Subject and/or parents(s)/legal guardian(s) must provide the signed study-specific informed consent prior to initiation of any study procedure.
Exclusion Criteria:
- Subjects received influenza vaccine within the previous 6 months;
- History of hypersensitivity to eggs or hen's protein, polymyxin B, or neomycin, or similar pharmacological effects to study vaccine;
- 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, 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, IUD, barrier device or abstinence) throughout the study;
- Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before study vaccination;
- Immunodeficiency, or under immunosuppressive treatment;
- Receipt of live virus vaccine within 1 month prior to study vaccination or expect 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;
- 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;
- Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AdimFlu-V
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2012-2013 season) of the AdimFlu-V.
Time Frame: Change from baseline for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI) at 28 days post immunization
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Serum samples will be obtained prior to vaccination, and 4 weeks post each 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.
Subjects will be considered to be seronegative if serum HAI titer < 1:10.
The seroconversion is defined as the post-vaccination serum HAI titer at least 1:40 for whom had negative pre-vaccination or a four-fold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.
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Change from baseline for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI) at 28 days post immunization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-V.
Time Frame: 7 days of each vaccination and 8 weeks after last vaccination
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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 each 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. In regard to the long term safety of the study vaccine, the significant and/or serious adverse event(s) will be recorded during the 8 weeks follow up after the scheduled last vaccination. |
7 days of each vaccination and 8 weeks after last vaccination
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLUV12T13C
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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