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Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster

NCT04992182 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2021-08-05

No results posted yet for this study

Summary

Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Placebo

0.3 mL IM saline solution

BIOLOGICAL

Inactivated vaccine booster

0.5 mL IM

BIOLOGICAL

mRNA vaccine booster

0.3 mL IM

DRUG

Viral vector vaccine booster

0.5 mL IM

Sponsors & Collaborators

  • Ministry of Health, Chile

    collaborator OTHER_GOV

  • University of Chile

    collaborator OTHER

  • Pontificia Universidad Catolica de Chile

    collaborator OTHER

  • Universidad del Desarrollo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2021-08-31
Completion
2022-06-30
FDA Drug
Yes

Countries

  • Chile

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 NCT04992182 on ClinicalTrials.gov