Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Influenza vaccine (split virion, inactivated)
AdimFlu-S
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Immunogenicity
Eligibility 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:
-
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AdimFlu-S
Arm Description
Outcomes
Primary Outcome Measures
Immunogenicity endpoint: Seroprotection rate
Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
Immunogenicity endpoint: Seroconversion rate
The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer < 1:10.
Immunogenicity endpoint: Geometric mean folds increase in HAI titer
Secondary Outcome Measures
Safety: Reactogenicity events
Reactogenicity events are pre-specified adverse events systematically 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, headache, muscle aches, 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.
Safety: Serious and non-serious adverse events
Full Information
NCT ID
NCT01752881
First Posted
December 17, 2012
Last Updated
December 17, 2012
Sponsor
Adimmune Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01752881
Brief Title
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Official Title
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (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
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 three weeks 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccine, Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AdimFlu-S
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine (split virion, inactivated)
Other Intervention Name(s)
AdimFlu-S Influenza Vaccine
Intervention Description
AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013
Dosage: 0.5mL/per syringe
Administration route: Intramuscular Injection, once
Intervention Type
Biological
Intervention Name(s)
AdimFlu-S
Primary Outcome Measure Information:
Title
Immunogenicity endpoint: Seroprotection rate
Description
Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
Time Frame
At 3 weeks after vaccination
Title
Immunogenicity endpoint: Seroconversion rate
Description
The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer < 1:10.
Time Frame
At 3 weeks after vaccination
Title
Immunogenicity endpoint: Geometric mean folds increase in HAI titer
Time Frame
At 3 weeks after vaccination
Secondary Outcome Measure Information:
Title
Safety: Reactogenicity events
Description
Reactogenicity events are pre-specified adverse events systematically 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, headache, muscle aches, 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.
Time Frame
7 days after vaccination
Title
Safety: Serious and non-serious adverse events
Time Frame
Through day 21 post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Jen Chang, MD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
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