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Fourth Dose of mRNA COVID-19 Vaccine in Residents of LTCFs

NCT04978038 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2022-06-30

No results posted yet for this study

Summary

This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).

Conditions

  • SARS-CoV2 Infection
  • Coronavirus Infection

Interventions

DRUG

mRNA- COVID-19

Pfizer-BioNtech mRNA- COVID-19 0.3ml dose administered intramuscularly

DRUG

Prevnar13

Pfizer Prevnar-13 pneumococcal vaccine 0.5ml dose administered intramuscularly

Sponsors & Collaborators

  • Mark Loeb

    lead OTHER

Principal Investigators

  • Mark Loeb, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2022-11-15
Completion
2022-12-31
FDA Drug
Yes

Countries

  • Canada

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 NCT04978038 on ClinicalTrials.gov