CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 374 enrolled
Drug / intervention
COVIVAC vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05940194
NCT05940194Phase 2Completed
CompareCT.gov

A Phase 1/2 Randomized, Active- Controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults ≥ 18 and ≥ 60 Years Old in Vietnam

Institute of Vaccines and Medical Biologicals, Vietnam·interventional·Posted Jul 11, 2023·Updated Jan 15, 2025

In Brief

A Phase 2 clinical trial evaluating COVIVAC vaccine for COVID-19. Completed, enrolled 374 participants across 1 site.

Detailed Summary

This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts. After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2. In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesVietnam
CollaboratorsNational Institute of Hygiene and Epidemiology, Vietnam, Center for Disease Control of Thai Binh Province, Vietnam

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 11, 2023
Enrollment StartAug 11, 2021
Primary CompletionOct 18, 2021
Study CompletionMar 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.0 years ago

Interventions

COVIVAC vaccinebiological

For prevention Covid-19