Clinical Trials List
2017-07-01 - 2018-09-30
Phase II
Terminated5
ICD-10J09.X2
Influenza due to identified novel influenza A virus with other respiratory manifestations
ICD-10J10
Influenza due to other identified influenza virus
A Phase 2, Double-blind, Randomized Controlled Study to Evaluate Immunogenicity and Safety of Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult Volunteers
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Trial Applicant
Clinipace Taiwan Co., Ltd
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Sponsor
Advagene Biopharma.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Un-in Wu Division of General Internal Medicine
- SUNG-CHING PAN Division of General Internal Medicine
- Shan-Chwen Chang Division of General Internal Medicine
- 黃怡嘉 Division of General Internal Medicine
- 陳冠州 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- Tsong-Yih Ou Division of Infectious Disease
- Hsin-Wei Huang Division of Ophthalmology
- Fu-Lun Chen Division of Infectious Disease
The Actual Total Number of Participants Enrolled
77 Completed
Audit
None
Co-Principal Investigator
- 林德宇 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Hsiao-Ting Chang Division of Family Medicine
- 黃怡銘 Division of Ophthalmology
- 劉瑞瑤 Division of Family Medicine
- 周昱百 Division of Ophthalmology
- 呂信邦 Division of Family Medicine
- 黃信彰 Division of Family Medicine
- Shih-Jen Chen Division of Ophthalmology
- YI-TSUNG LIN Division of Infectious Disease
- 陳育群 Division of Family Medicine
- Fu-Der Wang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yen-Chung Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
138 Completed
Audit
CRO
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
22.5µg HA with 45µg AD07010
Endpoints
• Change from pre- to post-vaccination serum Geometric mean titers (GMT) of
hemagglutinin inhibition (HI) antibody at Day 29(±2)
Secondary Endpoints:
Immunogenicity: After 2 doses of AD07030 at Day 29(±2), in terms of:
1) Derived variables: in terms of HI titers for: Seroconversion Rate (SCR), Seroconversion
Factor (SCF), and Seroprotection Rate (SPR)
2) Change from pre- to post-vaccination GMT of mucosal anti-HA IgA antibody
3) Change from pre- to post-vaccination GMT of anti- LTh(αK) antibodies
4) Change from pre- to post-vaccination GMT of virus neutralization titer
Safety: Safety and tolerability with 2 doses of AD07030 in healthy adults for:
• Percentage, intensity and relationship to solicited local and general Adverse Events (AEs)
during a 7-day follow-up period after each IP administration
• Incidence of Adverse Event (AE) and Serious Adverse event (SAE) throughout the study
• Tolerability, defined as proportion of subjects discontinued as result of adverse events
• Changes in clinical and laboratory parameters from baseline (physical examination, vital
signs, nasal examination, ophthalmoscopy, electrocardiogram and clinical laboratory
examination (hematology, blood chemistry and urinalysis)
Inclution Criteria
2.Should be physically and mentally healthy and free of significant medical condition as determined by:
•Medical history;
•Physical examination;
•Clinical judgment of the Investigator
3.Negative urine β–human chorionic gonadotropin in women of childbearing potential (WOCBP; defined as women ≤ 50 years old of age or
history of amenorrhea for ≤12 months) prior to administration of first dose of Investigational Product.
4.WOCBP and male subjects having female partners, who are WOCBP, should be protected by effective contraceptive method (e.g. oral contraceptive and condom, intra-uterine device and condom, diaphragm with spermicide and condom) throughout the study period.
5.Willing and able to give written informed consent prior to Screening and comply with study procedure.
Exclusion Criteria
2.Received any vaccination (other than influenza) within 28 days prior to Screening.
3.Has previously experienced anaphylaxis or a life-threatening reaction; or has history of allergy or hypersensitivity to egg proteins, chicken proteins, any of the components of Investigational Product, or other vaccine containing same substances.
4.History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months prior to administration of first dose of Investigational Product.
5.Had active allergic rhinitis within 28 days prior to administration of first dose of Investigational Product.
6.Has documented history of diarrhea within 28 days prior to administration of first dose of Investigational Product.
7.Have used or been administered any intranasal medication or nasal topical treatment within 7 days prior to Screening.
8.Acute respiratory illness within 7 days prior to administration of first dose of Investigational Product.
9.Had administration of systemic antibiotics or antivirals within 7 days prior to Screening (excluding topical/external use of antibiotics).
10.Acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to administration of first dose of Investigational Product.
11.With acute disease (defined as fever with body temperature >38.0°C), within 3 days prior to administration of first dose of Investigational Product.
12.Having any serious chronic illness, including but not limited to, cardiovascular, pulmonary, hepatic, metabolic, renal or any auto-immune disorders, at a stage that could interfere with trial conduct or completion.
13.Any confirmed or suspected immunosuppressive or immune-deficient condition, based on medical history and physical examination.
14.Documented history of Bell’s palsy or neurological disorder.
15. Receive aspirin (Salicylate) anytime in the study from screening (Visit 1)
16. A positive test for HIV antibody
17. Receipt of any immunoglobulins and/or blood products within 3months of study Screening.
18. Pregnant or breast-feeding women
19. Require extended long-term use of steroids including parenteral steroids or high dose inhaled steroids or have used within 28 days
prior to Screening
20. Participated in any other clinical investigation or use of any investigational therapy other than AD07030, within 4 weeks (28 days) or 5 half-lives, whichever is longer, before Screening.
21. Unable to communicate reliably with the Investigator or unlikely to cooperate with the requirements of the study procedures or
schedule, or other cases judged by the Investigator to be ineligible for participation in the study.
22. Other cases judged by the Investigator to be ineligible for participation in the study.
The Estimated Number of Participants
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Taiwan
354 participants
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Global
0 participants
