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A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers

NCT04773067 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3877

Last updated 2022-08-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

UB-612

Around 3300 adult subjects and 330 adolescent subjects will receive 2 doses of 100 µg UB-612 vaccine. The subjects will be invited to have the 3rd dose after unblinded.

BIOLOGICAL

Placebo

Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%.

Sponsors & Collaborators

  • Vaxxinity, Inc.

    collaborator INDUSTRY

  • United Biomedical Inc., Asia

    lead INDUSTRY

Principal Investigators

  • Chang-Yi Wang, Ph.D. · United Biomedical Inc., Asia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-30
Primary Completion
2022-03-08
Completion
2022-03-08

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04773067 on ClinicalTrials.gov