Back to resultsA 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
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
AdimFlu-V
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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.
Sites / Locations
- Chang Gung Memorial Hospital at Linkuo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AdimFlu-V
Arm Description
Outcomes
Primary Outcome Measures
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2012-2013 season) of the AdimFlu-V.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01755364
Brief Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
January 28, 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adimmune Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged equal to or over 3 years old and less than 9 years old will received two doses of vaccine (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days). Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events observed since first vaccination to 28 days after the last dose of vaccination, and serious adverse events during the observation. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each 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 subjects will be followed, either by clinical visit or by telephone contact, for 8 weeks after the last vaccination for safety reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AdimFlu-V
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AdimFlu-V
Primary Outcome Measure Information:
Title
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2012-2013 season) of the AdimFlu-V.
Description
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.
Time Frame
Change from baseline for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI) at 28 days post immunization
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
7 days of each vaccination and 8 weeks after last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Chang Gung Memorial Hospital at Linkuo
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
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
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