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Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly

NCT04938323 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2022-07-06

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of Bacille Calmette-Guérin (BCG) vaccination compared to placebo against acute respiratory infections in the elderly who are less protected by standard vaccines against influenza than other age groups. The investigators hypothesize that BCG vaccination can reduce incidence of infection and severity of a range of acute respiratory infections. Patients who are residents of participating long-term care facilities (LTCFs), who agree to participate in the study, or with a legal guardian who agrees on their behalf, will be randomly assigned to receive BCG vaccination or a placebo. Participants will be followed for up to six months to assess the incidence of infection and the severity of a range of acute respiratory infections.

Conditions

  • Acute Respiratory Infection

Interventions

DRUG

BCG Vaccine

.1 mL of reconstituted BCG vaccine given intradermally at baseline.

DRUG

Placebo

.1 mL of diluent (saline) given intradermally at baseline

Sponsors & Collaborators

  • Chang-Hua Hospital

    collaborator OTHER_GOV

  • Harvard Medical School (HMS and HSDM)

    lead OTHER

Principal Investigators

  • Megan Murray, ScD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-07-31
Completion
2022-09-30

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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 NCT04938323 on ClinicalTrials.gov