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A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers
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ClinicalTrials.gov Identifier: NCT04773067 |
Recruitment Status :
Terminated
(Under the limited resources, to re-plan the ongoing clinical trials of this product.)
First Posted : February 26, 2021
Last Update Posted : August 26, 2022
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Sponsor:
United Biomedical Inc., Asia
Collaborator:
Vaxxinity, Inc.
Information provided by (Responsible Party):
United Biomedical Inc., Asia
Tracking Information | |||||
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First Submitted Date ICMJE | February 23, 2021 | ||||
First Posted Date ICMJE | February 26, 2021 | ||||
Last Update Posted Date | August 26, 2022 | ||||
Actual Study Start Date ICMJE | January 30, 2021 | ||||
Actual Primary Completion Date | March 8, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers | ||||
Official Title ICMJE | A Phase II, Placebo-controlled, Randomized, Observer-blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of UB-612 Vaccine Against COVID-19 in Adolescent, Younger and Elderly Adult Volunteers | ||||
Brief Summary | This is a phase II, observer-blind, multiple-centre, randomized, placebo-controlled study to evaluate the immunogenicity, safety, tolerability and lot consistency of 2 doses of UB-612 vaccine in adolescent, younger and elderly adults. Around 3850 adult subjects will be randomized to be composed of the core group, while around 385 adolescents will be randomized to be the supplementary group. Subjects will be unblinded at Visit 5, and subjects in the vaccine group will be encouraged to have 3rd dose of vaccination. | ||||
Detailed Description | This clinical study will be consisted of 7 clinical visits and one long-term follow-up visit. Subjects will also be unblinded at Visit 5, subjects in placebo group will withdraw from the study and subjects in vaccine group will be encouraged to have 3rd dose of vaccination (Day 197~Day 242) at Visit 6. Those who received 3rd dose will have Visit 7 (14 days after Visit 6) to check the booster effect. After Day 197, subjects will enter the long-term follow-up with a safety call bi-monthly. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | COVID-19 | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Wang CY, Hwang KP, Kuo HK, Peng WJ, Shen YH, Kuo BS, Huang JH, Liu H, Ho YH, Lin F, Ding S, Liu Z, Wu HT, Huang CT, Lee YJ, Liu MC, Yang YC, Lu PL, Tsai HC, Lee CH, Shi ZY, Liu CE, Liao CH, Chang FY, Chen HC, Wang FD, Hou KL, Cheng J, Wang MS, Yang YT, Chiu HC, Jiang MH, Shih HY, Shen HY, Chang PY, Lan YR, Chen CT, Lin YL, Liang JJ, Liao CC, Chou YC, Morris MK, Hanson CV, Guirakhoo F, Hellerstein M, Yu HJ, King CC, Kemp T, Heppner DG, Monath TP. A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants. J Clin Invest. 2022 May 16;132(10):e157707. doi: 10.1172/JCI157707. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
3877 | ||||
Original Estimated Enrollment ICMJE |
3850 | ||||
Actual Study Completion Date ICMJE | March 8, 2022 | ||||
Actual Primary Completion Date | March 8, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 85 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Taiwan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04773067 | ||||
Other Study ID Numbers ICMJE | V-205 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | United Biomedical Inc., Asia | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | United Biomedical Inc., Asia | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Vaxxinity, Inc. | ||||
Investigators ICMJE |
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PRS Account | United Biomedical Inc., Asia | ||||
Verification Date | June 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |