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Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes in an Elderly Population

NCT04983537 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-30

No results posted yet for this study

Summary

To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with counterpart regimens currently in use in Argentina among a population of persons aged 66 or above.

Conditions

  • COVID-19 Vaccines

Interventions

DRUG

Gam-COVID-Vac / Gam-COVID-Vac

A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.Comparisons will be made by contrasting the geometric means of antibody levels between each of the study arms. In addition, comparisons will be made as to whether or not the median antibody values of the alternative treatment groups are lower than: a) the 25th percentile of the median antibody value of the Gam COVID combination and b) whether the lower limit of the confidence interval of the differences in the GMC rate is lower than the conventional cut-off point of non-inferiority set at 0.67.

Sponsors & Collaborators

  • Ministerio de Salud de Ciudad Autónoma de Buenos Aires

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
66 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2021-09-26
Completion
2021-09-26

Countries

  • Argentina

Study Locations

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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 NCT04983537 on ClinicalTrials.gov