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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Johns Hopkins University | OTHER |
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The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/FLUAD® or RZV/Fluzone® High-Dose vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.
Intention-to-Treat (ITT) Population: Defined as all subjects who are randomized and vaccinated.
Modified Intention-to-Treat (mITT) Population: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine (FLUAD®) | Active Comparator | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. |
|
| Zoster Vaccine Recombinant (RZV) and High-Dose Quadrivalent Influenza Vaccine (Fluzone®) | Active Comparator | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLUAD® Quadrivalent | Biological | Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Modified Intention-to-Treat (mITT) Population | Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 65-69 | Modified Intention-to-Treat (mITT) Population | Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older | Modified Intention-to-Treat (mITT) Population | Up to 8 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Modified Intention-to-Treat (mITT) Population | Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®)in Each Study Group - Ages 65-69 |
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Inclusion Criteria:
Exclusion Criteria:
IIV or recombinant influenza vaccine (RIV) receipt during the respective 2021-2022 or 2022-2023 influenza season prior to study enrollment
Prior receipt of recombinant zoster vaccine (SHINGRIX®)
For non-COVID-19 Vaccines:
For COVID-19 Vaccines:
Have acute illness or exacerbation of chronic illness within 72 hours of study vaccination
Hospitalization within the last 30 days for any reason
History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration
Has immunosuppression as a result of an underlying illness or treatment, or use of chemotherapy or radiation therapy within the preceding 12 months
Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) *Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure
A history of autoimmune disease, that requires immunosuppressive agents or any other chronic medical condition considered clinically significant by the investigator
Use of chronic oral or intravenous administration (≥14 days) of immunosuppressive doses of steroids, i.e., prednisone >10 mg per day, immunosuppressants or other immune-modifying drugs within 30 days of starting this study. (Use of topical, nasal, or inhaled steroids is permitted)
Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable)
Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein
Contraindication to RZV including history of a severe allergic reaction to any component of the RZV vaccine (including saponin or polysorbate 80) or to dose 2 of RZV
History of Guillain-Barré syndrome
History of Hepatitis C or active Hepatitis B
Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
Dementia, any cognitive condition, or substance abuse that could interfere with study compliance
Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 28 days of vaccine receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 28 days following vaccine receipt
Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives
Anyone who is a relative of any research study personnel
Anyone who is an employee of any research study personnel
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Schmader, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39446325 | Derived | Schmader KE, Walter EB, Talaat KR, Rountree W, Poniewierski M, Randolph E, Leng SX, Wunderlich B, McNeil MM, Museru O, Broder KR. Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2440817. doi: 10.1001/jamanetworkopen.2024.40817. | |
| 37781954 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the quadrivalent adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. FLUAD® Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
| FG001 | Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. Fluzone® HD Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the quadrivalent adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. FLUAD® Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Modified Intention-to-Treat (mITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the quadrivalent adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. FLUAD® Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular Accident (CVA), Unspecified Mechanism | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Schmader | Duke University | 919-660-7572 | kenneth.schmader@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2024 | Jun 28, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2024 | Jun 28, 2024 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2022 | Mar 10, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000075662 | Injection Site Reaction |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005119 | Extravasation of Diagnostic and Therapeutic Materials |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Subjects, study coordinators, and investigators will be blinded to the type of influenza vaccine administered in conjunction with the Recombinant Zoster Vaccine, Adjuvanted.
|
| Fluzone® High-Dose Quadrivalent | Biological | Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
|
|
| SHINGRIX® | Biological | Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
|
|
Modified Intention-to-Treat (mITT) Population |
| Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older | Modified Intention-to-Treat (mITT) Population | Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events | Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 65-69 | Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events | Up to 8 days post-vaccination |
| Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older | Modified Intention-to-Treat (ITT) Population | Up to 8 days post-vaccination |
| Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Intention-to-Treat (ITT) Population | Up 43 days post-vaccination |
| Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Intention-to-Treat (ITT) Population | Up 43 days post-vaccination |
| Durham |
| North Carolina |
| 27710 |
| United States |
| de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
| BG001 | Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. Fluzone® HD Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. Fluzone® HD Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine |
|
|
|
| Primary | Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 65-69 | Modified Intention-to-Treat (mITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects ages 65-69 who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Primary | Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older | Modified Intention-to-Treat (mITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects ages 70 or older who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Modified Intention-to-Treat (mITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®)in Each Study Group - Ages 65-69 | Modified Intention-to-Treat (mITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older | Modified Intention-to-Treat (mITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects ages 70 or older who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events | Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 65-69 | Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events | Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older | Modified Intention-to-Treat (ITT) Population | Modified Intention-to-Treat (mITT) Population: All subjects ages 70 or older who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary. | Posted | Count of Participants | Participants | Up to 8 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Intention-to-Treat (ITT) Population | ITT Population: All subjects who are randomized and vaccinated (received at least one study vaccine). | Posted | Count of Participants | Participants | Up 43 days post-vaccination |
|
|
|
|
| Secondary | Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Intention-to-Treat (ITT) Population | ITT Population: All subjects who are randomized and vaccinated (received at least one study vaccine). | Posted | Count of Participants | Participants | Up 43 days post-vaccination |
|
|
|
|
| 0 |
| 130 |
| 4 |
| 130 |
| 32 |
| 130 |
| EG001 | Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine | In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6. Fluzone® HD Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine | 0 | 137 | 5 | 137 | 21 | 137 |
| Hepatocellular Carcinoma | Hepatobiliary disorders | Systematic Assessment |
|
| Acute Hyperkalemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute pulmonary embolism and acute deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Left partial cranial nerve III palsy | Nervous system disorders | Systematic Assessment |
|
| Revision of right shoulder rotator cuff surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalization for pacemaker due to arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease (COPD) exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D064419 | Chemically-Induced Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |