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A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).

Primary Purpose

Healthy Participants

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination [RSVpreF+BNTb162b2]
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
RSVpreF
QIV
Normal Saline Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Participants focused on measuring SARS-CoV-2, COVID-19, Flu, Influenza, Vaccine, RSV, Respiratory Syncytial Virus, Combination vaccine, mRNA vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Substudy A Inclusion Criteria: Male or female participants ≥65 years of age at Visit 1 (Day 1). Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Participants who have received at least 3 prior US authorized mRNA COVID 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before Visit A101 (Day 1). Substudy A Exclusion Criteria: A confirmed diagnosis of COVID 19, RSV infection, or influenza ≤120 days before study intervention administration. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Allergy to egg proteins (egg or egg products) or chicken proteins. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study. Receipt of any influenza vaccine ≤120 days before study enrollment. Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Sites / Locations

  • West Coast Research
  • Marvel Clinical Research
  • Artemis Institute for Clinical Research
  • California Research Foundation
  • Orange County Research Center
  • Diablo Clinical Research, Inc.
  • Clinical Research Consulting
  • Indago Research & Health Center, Inc
  • Wr-Msra.Llc
  • Optimal Research
  • Suncoast Research Group
  • Clinical Site Partners, LLC dba Flourish Research
  • Great Lakes Clinical Trials - Gurnee
  • Optimal Research
  • Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO
  • Las Vegas Clinical Trials
  • Las Vegas Clinical Trials
  • Drug Trials America
  • Accellacare - Wilmington - 1917 Tradd Court
  • Accellacare - Wilmington
  • Centricity Research Columbus Ohio Multispecialty
  • Coastal Carolina Research Center
  • Clinical Research Associates Inc
  • Headlands Research - Brownsville
  • DM Clinical Research - Cy Fair
  • DM Clinical Research - Bellaire
  • SMS Clinical Research
  • Clinical Trials of Texas, LLC
  • DM Clinical Research
  • J. Lewis Research, Inc. / Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Virginia Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Group 7

Arm Description

Combination [RSVpreF+BNT162b2] + Quadrivalent influenza vaccine (QIV)

Combination [RSVpreF+BNT162b2] + placebo

BNT162b2 + placebo

RSVpreF + placebo

QIV + placebo

Coadministration RSVpreF + bivalent BNT162b2 + placebo

Coadministration RSVpreF + bivalent BNT162b2 + QIV

Outcomes

Primary Outcome Measures

Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling
Percentage of participants reporting systemic events
Fever, fatigue, headache, vomiting, diarrhea, chills, new or worsened muscle pain, and new or worsened joint pain
Percentage of participants reporting adverse events
As elicited by investigational site staff
Percentage of participants reporting serious adverse events
As elicited by investigational site staff
Group 1 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
As measured at central laboratory.
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
As measured at central laboratory.
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
As measured at central laboratory.
Group 1 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratios (GMRs) of hemagglutination inhibition (HAI) titers.
As measured at central laboratory.
Group 2 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
As measured at central laboratory.
Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
As measured at central laboratory.
Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers NTs
As measured at central laboratory.

Secondary Outcome Measures

Group 7 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
As measured at central laboratory
Group 7 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
As measured at central laboratory
Group 7 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
As measured at central laboratory
Group 7 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers.
As measured at central laboratory
Group 6 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
As measured at central laboratory
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
As measured at central laboratory
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
As measured at central laboratory

Full Information

First Posted
May 31, 2023
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05886777
Brief Title
A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).
Official Title
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATE(S) AGAINST INFECTIOUS RESPIRATORY ILLNESSES, INCLUDING COVID-19 AND RSV, IN HEALTHY INDIVIDUALS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is tolearn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections. This study is seeking participants who: are 65 years of age or older. are healthy or have well-controlled chronic conditions. in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1). have not had a flu shot in the last 120 days. agree to be present for all study visits, procedures, and blood draws. Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
SARS-CoV-2, COVID-19, Flu, Influenza, Vaccine, RSV, Respiratory Syncytial Virus, Combination vaccine, mRNA vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1079 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Combination [RSVpreF+BNT162b2] + Quadrivalent influenza vaccine (QIV)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Combination [RSVpreF+BNT162b2] + placebo
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
BNT162b2 + placebo
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
RSVpreF + placebo
Arm Title
Group 5
Arm Type
Active Comparator
Arm Description
QIV + placebo
Arm Title
Group 6
Arm Type
Experimental
Arm Description
Coadministration RSVpreF + bivalent BNT162b2 + placebo
Arm Title
Group 7
Arm Type
Experimental
Arm Description
Coadministration RSVpreF + bivalent BNT162b2 + QIV
Intervention Type
Biological
Intervention Name(s)
Combination [RSVpreF+BNTb162b2]
Intervention Description
Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intervention Description
Bivalent BNT162b2 given as an intramuscular injection
Intervention Type
Biological
Intervention Name(s)
RSVpreF
Intervention Description
RSVpreF given as an intramuscular injection
Intervention Type
Biological
Intervention Name(s)
QIV
Intervention Description
Licensed QIV given as an intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Normal Saline Placebo
Intervention Description
Normal saline (0.9% sodium chloride solution for injection)
Primary Outcome Measure Information:
Title
Percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling
Time Frame
For up to 7 days following vaccination (Day 7)
Title
Percentage of participants reporting systemic events
Description
Fever, fatigue, headache, vomiting, diarrhea, chills, new or worsened muscle pain, and new or worsened joint pain
Time Frame
For up to 7 days following vaccination (Day 7)
Title
Percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
Within 1 month following vaccination (Day 28)
Title
Percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
Within 6 months following vaccination (Day 175)
Title
Group 1 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Title
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Title
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Title
Group 1 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratios (GMRs) of hemagglutination inhibition (HAI) titers.
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Title
Group 2 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Title
Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Title
Group 2 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers NTs
Description
As measured at central laboratory.
Time Frame
1 month after vaccination (Day 28)
Secondary Outcome Measure Information:
Title
Group 7 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)
Title
Group 7 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)
Title
Group 7 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)
Title
Group 7 vs Group 5 noninferiority analysis: Influenza strain-specific geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers.
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)
Title
Group 6 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)
Title
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)
Title
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
Description
As measured at central laboratory
Time Frame
1 month after vaccination (Day 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Substudy A Inclusion Criteria: Male or female participants ≥65 years of age at Visit 1 (Day 1). Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Participants who have received at least 3 prior US authorized mRNA COVID 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before Visit A101 (Day 1). Substudy A Exclusion Criteria: A confirmed diagnosis of COVID 19, RSV infection, or influenza ≤120 days before study intervention administration. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Allergy to egg proteins (egg or egg products) or chicken proteins. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study. Receipt of any influenza vaccine ≤120 days before study enrollment. Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
West Coast Research
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research Consulting
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Wr-Msra.Llc
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Optimal Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Clinical Site Partners, LLC dba Flourish Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Great Lakes Clinical Trials - Gurnee
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Las Vegas Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Las Vegas Clinical Trials
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Accellacare - Wilmington - 1917 Tradd Court
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Centricity Research Columbus Ohio Multispecialty
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Clinical Research Associates Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Headlands Research - Brownsville
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Facility Name
DM Clinical Research - Cy Fair
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
DM Clinical Research - Bellaire
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
SMS Clinical Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Virginia Research Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C5481001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).

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