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Phase II/III Study of the AVX/COVID-12 Vaccine Against COVID-19 Applied as a Booster.

NCT05710783 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 4065

Last updated 2025-10-02

No results posted yet for this study

Summary

This is a phase II/III parallel, double-blind, active-controlled, non-inferiority study to evaluate immunogenicity and safety of a booster immunization scheme of a single intramuscular dose of the recombinant vaccine against SARS-CoV-2 (AVX/COVID-12 vaccine) based on live recombinant Newcastle disease virus (rNDV) vector in healthy adults with a history of vaccination against COVID-19. The study is divided into two phases with immuno-bridging and 3000 healthy subjects showing evidence of prior immunity to SARS-CoV-2 are estimated to enrol. To verify non-inferiority in a determined number of subjects an intramuscular dose of the COVID-19 vaccine (ChAdOx-1-S\[recombinant\]) shall be used as active control in originally randomised subjects. The study shall be carried out in several sites of clinical research in Mexico.

Conditions

Interventions

BIOLOGICAL

AVX-COVID/12

Single dose IM administration of a Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

BIOLOGICAL

ChAdOx-1-S[recombinant]

Single dose IM administration of ChAdOx1 nCOV-19 (Astra-Zeneca) adenovirus-vectored vaccine

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Enfermedades Respiratorias

    collaborator OTHER_GOV

  • Laboratorio Avi-Mex, S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Gustavo Peralta · Laboratorio Avi-Mex, S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2022-12-28
Completion
2023-09-10

Countries

  • Mexico

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 NCT05710783 on ClinicalTrials.gov