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Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

NCT05378191 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2022-05-18

No results posted yet for this study

Summary

CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.

Conditions

  • Covid19

Interventions

DRUG

COMIRNATY

One dose of COMIRNATY

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Cristobal Belda Iniesta, MD, PhD · Instituto de Salud Carlos III

  • Jesús Frías Iniesta, MD, PhD · Spanish Clinical Research Network - SCReN

  • Jose R Arribas, MD, PhD · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2022-08-22
Completion
2022-12-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT05378191 on ClinicalTrials.gov