NCT04978038

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

Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Mark Loeb · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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).

Detailed description

The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine as compared to control (PCV13) leads to an increase in detectable neutralizing antibodies. Participants will be randomized to receive either the Pfizer COVID-19 vaccine or the Pnemoccocal Prevnar-13 vaccine at baseline after bloodwork is drawn. Another blood sample will be taken 28 days later. After completion of the study, participants in the control group (pneumococcal Prevnar-13 vaccine) will be given a fourth dose of mRNA COVID-19 vaccine and will have their blood drawn 28 days post-vaccination.

Conditions

• SARS-CoV2 Infection
• Coronavirus Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-11-15
• Completion: 2022-12-31
• First posted: 2021-07-27
• Last updated: 2022-06-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study