Clinical Trials List
Protocol NumberADIMQIS20160328
NCT Number(ClinicalTrials.gov Identfier)NCT04101435
2016-12-13 - 2017-10-30
Phase III
Terminated2
ICD-10J10.1
Influenza due to other identified influenza virus with other respiratory manifestations
A Phase III Study of Immunogenicity and Safety Evaluation of AdimFlu-S Quadrivalent Inactivated Influenza Vaccine (QIS) in Healthy Subjects Aged 3 Years Old to 17 Years Old
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Trial Applicant
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Sponsor
Adimmune Corporation
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳俊仁 Division of Pediatrics
- 張羅以 Division of Pediatrics
- Chou-Cheng Lai Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chun-yi Lu Division of Pediatrics
- 蔡幸真 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 楊宗儒 Division of Pediatrics
- 賴貞吟 Division of Pediatrics
- 黃文輝 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Influenza
Objectives
Objectives
The purpose of this study is to evaluate the antibody response to each of the four influenza
vaccine strains included in the study vaccine, as measured by hemagglutination inhibition
(HAI) at 4 weeks after last dose of study vaccine in young subjects aged between 3 years
old and 17 years old.
Test Drug
Quadrivalent inactivated split (QIS) influenza vaccine (AdimFlu-S (QIS)
Active Ingredient
A/California/7/2009 (H1N1)
A/Switzerland/9715293/2013 (H3N2)
B /Phuket/3073/2013
B/Brisbane/60/2008
A/Switzerland/9715293/2013 (H3N2)
B /Phuket/3073/2013
B/Brisbane/60/2008
Dosage Form
Injection
Injection
Injection
Injection
Injection
Injection
Injection
Dosage
30 μg/mL
30 μg/mL
30 μg/mL
30 μg/mL
30 μg/mL
30 μg/mL
30 μg/mL
Endpoints
1. Primary endpoint(s)
The primary endpoint of immunogenicity evaluation will be the seroconversion rate
(SCR, 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) and geometric mean folds increase (GMTR, defined as the ratio of post- to
pre-vaccination in HAI titer.).
2. Secondary endpoints:
The secondary objective is to evaluate the immunogenicity, safety and tolerability
profiles including the seroprotection rate, the presence or absence of the pre-specified
reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S
(QIS) manufactured by Adimmune Corporation.
The secondary endpoint will be the seroprotection rate which is defined as the
proportion of subjects with HAI titer ≥40.
The primary endpoint of immunogenicity evaluation will be the seroconversion rate
(SCR, 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) and geometric mean folds increase (GMTR, defined as the ratio of post- to
pre-vaccination in HAI titer.).
2. Secondary endpoints:
The secondary objective is to evaluate the immunogenicity, safety and tolerability
profiles including the seroprotection rate, the presence or absence of the pre-specified
reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S
(QIS) manufactured by Adimmune Corporation.
The secondary endpoint will be the seroprotection rate which is defined as the
proportion of subjects with HAI titer ≥40.
Inclution Criteria
Main inclusion criteria:
(1) Boys or girls aged 3 years old to 17 years old on the day of first vaccination;
(2) Subject and/or parents(s)/legal guardian(s) must be willing to comply with
planned study procedures and be available for all study visits;
(3) Subject must be in good physical health on the basis of medical history, physical
examination;
(4) Subject and/or parents(s)/legal guardian(s) must read and signed the
study-specific informed consent prior to initiation of any study procedure.
(1) Boys or girls aged 3 years old to 17 years old on the day of first vaccination;
(2) Subject and/or parents(s)/legal guardian(s) must be willing to comply with
planned study procedures and be available for all study visits;
(3) Subject must be in good physical health on the basis of medical history, physical
examination;
(4) Subject and/or parents(s)/legal guardian(s) must read and signed the
study-specific informed consent prior to initiation of any study procedure.
Exclusion Criteria
Main exclusion criteria:
(1) Subjects received influenza vaccine (Trivalent and/or Quadrivalent) within 6
months prior first vaccination.
(2) History of hypersensitivity to eggs or egg protein or similar pharmacological
effects to study medication;
(3) Personal or family history of Guillain-Barré Syndrome;
(4) An acute febrile illness within 1 week prior to first vaccination;
(5) Current upper respiratory illness (URI), including the common cold or nasal
congestion within 72 hours prior to first vaccination;
(6) Subjects with influenza-like illness as defined by the presence of fever
(temperature 38ºC) and at least two of the following four symptoms: headache,
muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
(7) Female subjects who are pregnant;
(8) Treatment with an investigational drug or device, or participation in a clinical
study, within 3 months before consent;
(9) Immunodeficiency, or under immunosuppressive therapies;
(10) Receipt of live virus vaccine within 1 month prior to first vaccination or expected
to receive vaccination before the last blood sampling for immunogenicity
evaluation;
(11) Receipt of any inactivated vaccine within 2 weeks prior to first vaccination or
expected to receive vaccination before the last blood sampling for
immunogenicity evaluation;
(12) Receipt of any blood products, including immunoglobulin from 3 months before
first vaccination to the last blood sampling for immunogenicity evaluation;
(13) Underlying condition in the investigators’ opinion may interfere with evaluation
of the vaccine.
(1) Subjects received influenza vaccine (Trivalent and/or Quadrivalent) within 6
months prior first vaccination.
(2) History of hypersensitivity to eggs or egg protein or similar pharmacological
effects to study medication;
(3) Personal or family history of Guillain-Barré Syndrome;
(4) An acute febrile illness within 1 week prior to first vaccination;
(5) Current upper respiratory illness (URI), including the common cold or nasal
congestion within 72 hours prior to first vaccination;
(6) Subjects with influenza-like illness as defined by the presence of fever
(temperature 38ºC) and at least two of the following four symptoms: headache,
muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
(7) Female subjects who are pregnant;
(8) Treatment with an investigational drug or device, or participation in a clinical
study, within 3 months before consent;
(9) Immunodeficiency, or under immunosuppressive therapies;
(10) Receipt of live virus vaccine within 1 month prior to first vaccination or expected
to receive vaccination before the last blood sampling for immunogenicity
evaluation;
(11) Receipt of any inactivated vaccine within 2 weeks prior to first vaccination or
expected to receive vaccination before the last blood sampling for
immunogenicity evaluation;
(12) Receipt of any blood products, including immunoglobulin from 3 months before
first vaccination to the last blood sampling for immunogenicity evaluation;
(13) Underlying condition in the investigators’ opinion may interfere with evaluation
of the vaccine.
The Estimated Number of Participants
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Taiwan
180 participants
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Global
0 participants
