Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-attenuated Respiratory Syncytial Virus Vaccine, RSV 6120/∆NS1, Lot RSV#018A, or RSV 6120/F1/G2/∆NS1, Lot RSV#016A, Delivered as Nose Drops to RSV-seropositive Children 12 to 59 Months of Age and RSV-seronegative Infants and Children 6 to 24 Months of Age

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

Study Overview

• Status: Completed
• Conditions: RSV Infection
• Intervention / Treatment: Biological: Placebo; Biological: RSV 6120/∆NS1; Biological: RSV 6120/F1/G2/∆NS1

Detailed Description

This study will evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

The vaccines will be evaluated in a stepwise fashion beginning with RSV-seropositive children (Group 1) and proceeding sequentially in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of RSV 6120/∆NS1, RSV 6120/F1/G2/∆NS1, or placebo at Day 0.

Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 participants will be followed for 28 days after inoculation, and Group 2 participants will remain on the study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. The expected duration of the initial study is 28 days for Group 1 participants and between 6 and 13 months for Group 2 participants, depending upon time of enrollment.

Study visits for all participants may include clinical assessments, blood collection, and nasal washes or nasal swabs. Additionally, participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University Center for Immunization Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

INCLUSION CRITERIA FOR RSV-SEROPOSITIVE CHILDREN

• Greater than or equal to 12 months of age and less than 60 months of age at the time of inoculation
• Screening serum specimen for RSV-neutralizing antibody is obtained within the calendar year of inoculation
• Seropositive for RSV antibody, defined as serum RSV-neutralizing antibody titer greater than or equal to 1:40
• Pre-inoculation serum sample for RSV-neutralizing antibody specimen is obtained no more than 56 days prior to inoculation
• In good health based on review of the medical record, history, and physical examination (PE) at the time of inoculation
• Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
• Growing normally for age as demonstrated on a standard growth chart and has a current height and weight above the 3rd percentile for age
• Expected to be available for the duration of the study
• Parent/guardian is willing and able to provide written informed consent

EXCLUSION CRITERIA FOR RSV-SEROPOSITIVE CHILDREN

• Born at less than 34 weeks gestation
• Maternal history of positive human immunodeficiency virus (HIV) test
• Evidence of chronic disease
• Known or suspected impairment of immune function
• Bone marrow/solid organ transplant recipient
• Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
• Suspected or documented developmental disorder, delay, or other developmental problem
• Cardiac abnormality requiring treatment
• Lung disease or reactive airway disease
• More than one episode of wheezing in the first year of life
• Wheezing episode or received bronchodilator therapy within the past 12 months
• Wheezing episode or received bronchodilator therapy after the age of 12 months
• Previous receipt of supplemental oxygen therapy in a home setting
• Previous receipt of an investigational RSV vaccine
• Previous receipt or planned administration of anti-RSV antibody product including ribavirin, RSV Ig or RSV mAb
• Previous receipt of immunoglobulin or any antibody products within the past 6 months
• Previous receipt of any other blood products within the past 6 months
• Previous anaphylactic reaction
• Previous vaccine-associated adverse reaction that was Grade 3 or above
• Known hypersensitivity to any vaccine component
• Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation

• Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to:

  • a person who is HIV-infected
  • a person who has received chemotherapy within the 12 months prior to enrollment
  • a person receiving immunosuppressant agents
  • a person living with a solid organ or bone marrow transplant
• Will attend a daycare facility that does not separate children by age and contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation

• Receipt of any of the following prior to enrollment:

  • any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
  • any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
  • another investigational vaccine or investigational drug within 28 days prior, or
  • salicylate (aspirin) or salicylate-containing products within the past 28 days

• Scheduled administration of any of the following after planned inoculation:

  • inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
  • any live vaccine other than rotavirus within the 28 days after, or
  • another investigational vaccine or investigational drug within the 28 days after

• Receipt of any of the following medications within 3 days of study enrollment:

  • systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
  • intranasal medications, or
  • other prescription medications except the permitted concomitant medications listed in the protocol

• Any of the following events at the time of enrollment:

  • fever (temporal or rectal temperature of greater than or equal to 100.4°F), or
  • upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
  • nasal congestion significant enough to interfere with successful inoculation, or
  • otitis media

INCLUSION CRITERIA FOR RSV-SERONEGATIVE INFANTS & CHILDREN

• Greater than or equal to 6 months of age and less than 25 months of age at the time of inoculation
• Screening and pre-inoculation serum specimens for RSV-neutralizing antibody are obtained no more than 42 days prior to inoculation
• Seronegative for RSV antibody, defined as serum RSV-neutralizing antibody titer less than 1:40
• In good health based on review of the medical record, history, and PE at the time of inoculation
• Received routine immunizations appropriate for age based on the ACIP Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger

• Growing normally for age as demonstrated on a standard growth chart, AND

  • If less than 1 year of age: has a current height and weight above the 5th percentile for age
  • If greater than or equal to 1 year of age: has a current height and weight above the 3rd percentile for age
• Expected to be available for the duration of the study
• Parent/guardian is willing and able to provide written informed consent

EXCLUSION CRITERIA FOR RSV-SERONEGATIVE INFANTS & CHILDREN

• Born at less than 34 weeks gestation
• Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age
• Maternal history of a positive HIV test
• Evidence of chronic disease
• Known or suspected infection or impairment of immunological functions
• Bone marrow/solid organ transplant recipient
• Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
• Suspected or documented developmental disorder, delay, or other developmental problem
• Cardiac abnormality requiring treatment
• Lung disease or reactive airway disease
• More than one episode of wheezing in the first year of life
• Wheezing episode or received bronchodilator therapy within the past 12 months
• Wheezing episode or received bronchodilator therapy after the age of 12 months
• Previous receipt of supplemental oxygen therapy in a home setting
• Previous receipt of an investigational RSV vaccine
• Previous receipt or planned administration of anti-RSV antibody product including ribavirin, RSV Ig, or RSV mAb
• Previous receipt of immunoglobulin or any antibody products within the past 6 months
• Previous receipt of any blood products within the past 6 months
• Previous anaphylactic reaction
• Previous vaccine-associated adverse reaction that was Grade 3 or above
• Known hypersensitivity to any study product component
• Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation

• Member of a household that, at the date of inoculation through the 28th day after inoculation, contains an immunocompromised individual including but not limited to:

  • a person who is HIV-infected
  • a person who has received chemotherapy within the 12 months prior to enrollment
  • a person receiving immunosuppressant agents
  • a person living with a solid organ or bone marrow transplant
• Attends a daycare facility that does not separate children by age and contains an infant less than 6 months of age at the date of inoculation through the 28th day after inoculation

• Receipt of any of the following prior to enrollment:

  • any inactivated influenza vaccine within 3 days prior, or
  • any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
  • any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
  • another investigational vaccine or investigational drug within 28 days prior, or
  • salicylate (aspirin) or salicylate-containing products within the past 28 days

• Scheduled administration of any of the following after planned inoculation

  • inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
  • any live vaccine other than rotavirus within the 28 days after, or
  • another investigational vaccine or investigational drug within the 56 days after

• Receipt of any of the following medications within 3 days of study enrollment:

  • systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
  • intranasal medications, or
  • other prescription medications except the permitted concomitant medications listed below
  • Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.

• Any of the following events at the time of enrollment:

  • fever (temporal or rectal temperature of greater than or equal to 100.4°F), or
  • upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
  • nasal congestion significant enough to interfere with successful inoculation, or
  • otitis media
  • contact with a person diagnosed with COVID-19 disease or active SARS-CoV-2 infection within the past 10 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: RSV 6120/∆NS1 Vaccine; Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.	Biological: RSV 6120/∆NS1; Delivered as nose drops
Experimental: Group 1: RSV 6120/F1/G2/∆NS1 Vaccine; Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.	Biological: RSV 6120/F1/G2/∆NS1; Delivered as nose drops
Placebo Comparator: Group 1: Placebo; Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.	Biological: Placebo; Delivered as nose drops
Experimental: Group 2: RSV 6120/∆NS1 Vaccine; Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.	Biological: RSV 6120/∆NS1; Delivered as nose drops
Experimental: Group 2: RSV 6120/F1/G2/∆NS1; Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.	Biological: RSV 6120/F1/G2/∆NS1; Delivered as nose drops
Placebo Comparator: Group 2: Placebo; Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.	Biological: Placebo; Delivered as nose drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)	Solicited adverse events (AE's) include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix IV of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4- life-threatening) following protocol-defined grading system outlined in Table 20 and 21 in the protocol document.	Measured through Day 10
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)	Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix IV of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (grade 1- mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 20 and Table 21 in the protocol document.	Measured through Day 28
Number of Participants With Unsolicited AEs (RSV-seropositive Participants)	Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.	Measured through Day 10
Number of Participants With Unsolicited AEs (RSV-seronegative Participants)	Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.	Measured through Day 28
Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)	A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: Results in death during the period of protocol-defined surveillance;; Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe;; Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting;; Results in a persistent or significant disability/incapacity;; Is a congenital anomaly or birth defect, OR; Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes above.	Measured through Day 28
Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)	A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: Results in death during the period of protocol-defined surveillance;; Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe;; Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting;; Results in a persistent or significant disability/incapacity;; Is a congenital anomaly or birth defect, OR; Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes above.	Measured through Day 56
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Participants)	Defined as 1) vaccine virus identified in nasal wash (a binary outcome based on nasal washes or done throughout the study period; Day 0 nasal wash will be counted as baseline) or 2) a greater than or equal to 4-fold rise in serum RSV neutralizing antibody titer or serum RSV F (IgG) titer from study entry to Study Day 28.	Measured through Day 28
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Participants)	Defined as 1) vaccine virus identified in nasal wash or nasal swab (a binary outcome based on nasal washes or nasal swabs done throughout the study period; Day 0 nasal wash or nasal swabs will be counted as baseline) or 2) a greater than or equal to 4-fold rise in serum RSV neutralizing antibody titer or serum RSV F (IgG) titer from study entry to Study Day 56.	Measured through Day 56
Peak Titer of Vaccine Virus Shed by Culture (RSV-seropositive Participants)	This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.	Measured at Days 0,3,4,5,6,7 and 10.
Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Participants)	This is the mean of the highest value per participant of the titer of vaccine virus (peak titer) shed measured by culture from all samples collected during the acute phase. Only participants who met the definition of infection with vaccine virus were included.	Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28
Duration of Virus Shedding in Nasal Washes (RSV-seropositive Participants)	As determined by a) culture and b) reverse transcription polymerase chain reaction (rRT-PCR)	Measured at Days 0, 3, 4, 5, 6, 7 and 10
Duration of Virus Shedding in Nasal Washes or Nasal Swabs (RSV-seronegative Participants)	As determined by a) culture and/or b) qPCR. Only the participants who met the definition of infection with vaccine virus were included.	Measured at Days 0,3,5,7,10,12,14,17 and 28. Last day positive is reported.
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-Neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein (RSV-seropositive Participants)	Serum RSV-neutralizing antibody titers were assessed through an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.	Measured at Day 0 and Day 28
Number of Participants With a Greater Than or Equal To 4-fold Rise in Serum RSV-Neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein (RSV-seronegative Participants)	As defined as a greater than or equal to 4-fold rise in RSV Neutralizing Antibody Titer and/or Serum Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.	Measured through Day 56
RSV-Neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seropositive Participants)	Serum RSV-neutralizing antibody titers to RSV F glycoprotein were assessed by glycoprotein Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined a a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.	Measured through Day 28
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seronegative Participants)	Serum Antibody Titers to RSV F Glycoprotein were assessed by Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer paired specimens, between pre-inoculation and post-inoculation time points.	Measured through Day 56
The Frequency of Study-related Product Lower Respiratory Tract Illness (LRIs) in RSV-seropositive Participants.	Lower respiratory tract illness (LRI) is a Solicited Adverse Event (AE) as defined in Appendix IV of the protocol document. LRI includes: wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi, rales. The number of participants who experienced LRI was presented.	Day 0 through the 28th day following inoculation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the RSV Season	The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes/swabs collected during illness visits for MAARI- events, or a greater than 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events.	Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the RSV Season.	The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal specimens collected during illness visits for MAARI events or a greater than or equal to 4 fold rise in serum antibodies from pre- to post- RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1- mild to Grade 4- life threatening) following protocol-defined grading system outlined in Table 20 and 21 in the protocol document. Assessed by protocol -determined grading system.	Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study
Serum RSV Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in RSV Seronegative Subjects (Group 2) Infected With Wt-RSV During the RSV Surveillance.	The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators onf natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal specimens collected during illness visits for MAARI events or a greater than or equal to 4-fold rise in serum antibodies from pre-to post-RSV season in the absence of RSV-associated medical events.	Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study
Number of Participants With Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein in RSV-seronegative Subjects (Group 2) Infected With Wt-RSV During the RSV Surveillance	Serum RSV-neutralizing antibody titers and Serum IgG an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-RSV surveillance and post-RSV surveillance time points among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal specimens collected during illness visits for MAARI events or a > 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events	Measured pre-RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Ruth A. Karron, MD, Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: CIR 330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No