NCT04977479View on ClinicalTrials.gov

The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 8, 2021

Primary Completion Date

June 17, 2022

Study Completion Date

February 22, 2023

Conditions
Systemic Allergic Reaction
Interventions
BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)

mRNA vaccine for the prevention of COVID-19. Single dose (0.3mL) via IM.

OTHER

Placebo

Commercially available sterile, preservative-free 0.9% Sodium Chloride Injection, USP. Volume to match active vaccine controlling for and delivered as a single dose via IM.

BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine, Bivalent

mRNA vaccine booster bivalent (Original and Omicron BA.4/BA.5) for the prevention of COVID-19. Single dose (0.3mL) via IM.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04977479 - The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose | Biotech Hunter | Biotech Hunter