Back to resultsImmunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
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:
- Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination;
- Subject's parent(s) or 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's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
Exclusion Criteria:
- Subjects had received influenza vaccine;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- Personal or family history of Guillain- Barre' Syndrome;
- An acute febrile illness within 1 week prior to vaccination;
- Current upper respiratory illness (URI), 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;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;
- History of wheezing or bronchodilator use within 3 months prior to study vaccine;
- Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- 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.
Sites / Locations
- China Medicine University Hospital
Outcomes
Primary Outcome Measures
HA antibody titers will be determined using the WHO HAI reference technique.
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-S manufactured by Adimmune Corporation.
Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.
The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01355172
Brief Title
Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
Official Title
Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adimmune Corporation
4. Oversight
Data Monitoring Committee
Yes
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 seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.
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
Outcomes Assessor
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
AdimFlu-S
Intervention Description
0.25mL per injection 2 injections at 4 weeks apart
Primary Outcome Measure Information:
Title
HA antibody titers will be determined using the WHO HAI reference technique.
Time Frame
Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.
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-S manufactured by Adimmune Corporation.
Description
Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.
The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
Time Frame
(4 weeks after two doses of study vaccine, 4 weeks apart), Physical examination will be performed at each visit. Reactogenicity will be recorded for 7 days after each vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination;
Subject's parent(s) or 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's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
Exclusion Criteria:
Subjects had received influenza vaccine;
History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
Personal or family history of Guillain- Barre' Syndrome;
An acute febrile illness within 1 week prior to vaccination;
Current upper respiratory illness (URI), 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;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;
History of wheezing or bronchodilator use within 3 months prior to study vaccine;
Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
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.
Facility Information:
Facility Name
China Medicine University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
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