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Clinical Trials List

Protocol NumberADIMQIS-2018-01
NCT Number(ClinicalTrials.gov Identfier)NCT

2019-01-01 - 2020-12-31

Others

Recruiting8

ICD-10J09

Influenza due to certain identified influenza viruses

A Phase III Study of Immunogenicity and Safety Evaluation of AdimFlu-S (QIS) Quadrivalent Inactivated Influenza Vaccine in Healthy Subjects Aged 6 Months Old to 35 Months Old

  • Trial Applicant

    T-TOP Clinical Research Co., Ltd.

  • Sponsor

    Adimmune Corporation

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 梁昭鉉 Division of Pediatrics
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kao-Pin Hwang Division of Pediatrics
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Nan-Chang Chiu Division of Pediatrics
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林千裕 Division of Pediatrics
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yhu-Chering Huang Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Chuan Huang Division of Pediatrics
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林嘉玲 Division of Pediatrics
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Li-Min Huang Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Influenza

Objectives

The primary objective of the study is to demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to VaxigripTetra in terms of GMT of HAI antibodies at 28 days after last dose of study vaccines. More details on the endpoints used to assess this objective and how they will be analyzed are provided in Section 9.2.5.2. Criterion for non-inferiority demonstration: immunological non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval from the GMT ratio (VaxigripTetra over AdimFlu-S (QIS)) in terms of HAI antibody titer against each vaccine strain does not exceed 1.5 (3/2).

Test Drug

AdimFlu-S Quadrivalent Inactivated Influenza Vaccine(AdimFlu-S(QIS))

Active Ingredient

A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus
A/Hong Kong/2671/2019 (H3N2)-like virus
B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
B/Washington/02/2019 (B/Victoria lineage)-like virus

Dosage Form

Injection
Injection
Injection
Injection

Dosage

15 ug
15 ug
15 ug
15 ug

Endpoints

Primary endpoint:
The primary endpoint of non-inferiority immunogenicity evaluation will be demonstrated in
GMT between AdimFlu-S (QIS) and VaxigripTetra at 28 days post last vaccination.
2. Secondary endpoints:
(1) Analyze of seroconversion rates for non-inferiority between AdimFlu-S (QIS)
and VaxigripTetra.
(2) Demonstration of immunogenicity including GMT, GMTR, seroconversion rates
and seroprotection rates of AdimFlu-S (QIS) and VaxigripTetra.
(3) Description statistical analysis of proportion of subjects with reactogenicity events
within 7 Days after administration of study vaccines.
(4) Description statistical analysis of proportion of subjects with Adverse Events within 28
Days after administration of study vaccines.
(5) Extended follow-up for 6 months to evaluate the long term safety of subjects after study
vaccines administration.

Inclution Criteria

1. Subjects aged 6 to 35 months old (i.e. <36 months old) on the day of first vaccination;
2. Subject and/or subject’s legal representative(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 according to investigator’s judgment at Visit 1;
4. Subject’s legal representative(s) must read and sign the studyspecific informed consent prior to initiation of any study procedure.

Exclusion Criteria

1. Subjects received seasonal influenza vaccine or diagnosed with influenza infection
within 6 months prior to first vaccination;
2. History of severe hypersensitivity to study medication;
3. Personal or family history of Guillain-Barré Syndrome;
4. An acute febrile illness within 3 days prior to vaccination;
5. Acute disease and/or fever at the time of enrollment. Fever is defined as ear
temperature ≥38.0°C;
6. Treatment with an investigational drug or device within 30 days before consent;
7. Subject has immunodeficiency, or subject has Chronic administration (defined as
more than 14 consecutive days) of immunosuppressants or other immune-modifying
drugs within 3 months prior to the first vaccine dose. For corticosteroids, this will
mean a dose equivalent to either > 2 mg/kg/day of body weight, or to ≥ 20 mg/day of
prednisone for persons who weigh ≥ 10 kg, when administered for more than 2 weeks.
Inhaled and topical steroids are allowed;
8. Administration of any vaccine within 14 days prior to randomization;
9. Receipt of any blood products, including immunoglobulin from 3 months before first
vaccination to the last blood sampling for immunogenicity evaluation;
10. Subject under 1 year old with a birth weight <2500g;
11. Underlying condition in the investigators’ opinion may interfere with evaluation of
the vaccine.

The Estimated Number of Participants

  • Taiwan

    800 participants

  • Global

    800 participants

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