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NDV-HXP-S Vaccine Clinical Trial (COVIVAC)

NCT05940194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2025-01-15

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

COVIVAC vaccine

For prevention Covid-19

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Center for Disease Control of Thai Binh Province, Vietnam

    collaborator OTHER

  • Institute of Vaccines and Medical Biologicals, Vietnam

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2021-10-18
Completion
2022-03-11

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

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 NCT05940194 on ClinicalTrials.gov