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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.
This study will evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.
Participants will be randomly assigned to one of two groups to receive a single dose of intranasal RSV LID/ΔM2-2/1030s vaccine or placebo at study entry (Day 0). Group 1 (intensive) and Group 2 (less intensive) will differ only in the frequency of study visits and nasal swab collections.
Participants will receive study product between April 1 and October 15, outside of the RSV season, and 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. Participants' total study duration is between 6 and 13 months, depending upon time of enrollment.
Participants will attend several study visits throughout the study, which may include blood collection, nasal swabs, and physical examinations. Some of these visits may be remote if a stay at home order is put in place after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: RSV LID/ΔM2-2/1030s | Experimental | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). |
|
| Group 1: Placebo | Placebo Comparator | Participants will receive a single dose of placebo at study entry (Day 0). |
|
| Group 2: RSV LID/ΔM2-2/1030s | Experimental | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). |
|
| Group 2: Placebo | Placebo Comparator | Participants will receive a single dose of placebo at study entry (Day 0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV LID/ΔM2-2/1030s | Biological | 10^5 plaque-forming units (PFU); administered as nose drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade | Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix III 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 16 and Table 17 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2. | Measured through Day 28 |
| Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade | LRI may include wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi and rales as defined in Appendix III of the protocol document. A participant was only counted once in each LRI 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 16 and Table 17 in the protocol document. | Measured through Day 28 |
| Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity | 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 Who Experienced Serious Adverse Events (SAEs) | 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 listed above. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent 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 swabs collected during illness visits for MAARI events or a > 2.5-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 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 16 and Table 17 in the protocol document. |
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Inclusion Criteria:
≥ 6 months of age and <25 months of age at the time of inoculation
Screening and pre-inoculation serum specimens for respiratory syncytial virus (RSV)-neutralizing antibody are obtained no more than 42 days prior to inoculation
Seronegative for RSV antibody, defined as serum RSV-neutralizing antibody titer <1:40
In good health based on review of the medical record, history, and physical examination 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 World Health Organization (WHO) growth chart, AND
Expected to be available for the duration of the study
Parent/guardian is willing and able to provide written informed consent
Exclusion Criteria:
≤ 6 months of age and > 25 months of age at the time of inoculation
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 before or during pregnancy
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 medically diagnosed 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:
Attends a daycare facility that does not separate children by age and contains an infant <6 months of age at the date of inoculation through the 28th day after inoculation
Receipt of any of the following prior to enrollment:
Scheduled administration of any of the following after planned inoculation
Receipt of any of the following medications within 3 days of study enrollment:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth A. Karron, MD | Johns Hopkins Bloomberg School of Public Health (JHSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States | ||
| University of Rochester Medical Center |
Qualified researchers may request access to IPD that underlie results in a publication. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
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After publication
Qualified researchers
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Of the 111 participants that were screened, 81 met eligibility criteria and the parent agreed to enroll their child. The 81 children were then inoculated with study product.
Participants were recruited from pediatric practices and clinics in the greater Baltimore, MD/Washington, DC, Rochester, NY and Nashville, TN areas based on referral by the primary care provider or the provider's staff; and through electronic patient portals using IRB-approved messages. These recruitment methods targeted age-appropriate children between February, 2022 and March, 2023. The first participant was enrolled on 3/16/22 and the last participant was enrolled on 5/10/23.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| FG001 | Group 1: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Acute Phase (Days 0-28) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2023 |
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| Placebo | Biological | Administered as nose drops |
|
| Measured Day 0 through Day 56 after inoculation and During the RSV Surveillance Season (Date of seasonal pause in enrollment in year of inoculation through March 31) |
| Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer | Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. 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 at Day 0 and Day 56 |
| Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only) | This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by RT-qPCR. Group 1 participants only. Only participants who met the definition of infection with vaccine virus were included. | Measured at Days 5, 7, 10, 12 and additional illness visits between Days 0 and 28. |
| Number of Vaccinees Infected With RSV Vaccine Virus in Group 1 | Defined as shedding vaccine virus, detected by RT-qPCR, and/or ≥4-fold rise in RSV-specific serum antibodies, detected by enzyme-linked immunosorbent assay (ELISA) against the RSV F protein and/or an RSV-PRNT from study entry to Study Day 56 | Measured through Day 56 |
| Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31) |
| Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season | The number of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory illness (MAALRI) 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 swabs collected during illness visits for MAALRI events or a ≥ 2.5-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 LRI 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 16 and Table 17 in the protocol document. | Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31) |
| Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG | Serum RSV preF IgG titers and RSV postF IgG titers were assessed by an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a ≥4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points. | Measured at Day 0 and Day 56 |
| Rochester |
| New York |
| 14642 |
| United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
| FG002 | Group 2: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| FG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| COMPLETED |
|
| NOT COMPLETED |
|
| RSV Surveillance Phase Oct. 16-March 31 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| BG001 | Group 1: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| BG002 | Group 2: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| BG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade | Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix III 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 16 and Table 17 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2. | Study participants who received inoculation and were followed on study past Day 0 were included. | Posted | Count of Participants | Participants | Measured through Day 28 |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade | LRI may include wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi and rales as defined in Appendix III of the protocol document. A participant was only counted once in each LRI 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 16 and Table 17 in the protocol document. | Study participants who received inoculation and were followed on study past Day 0 were included. | Posted | Count of Participants | Participants | Measured through Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity | Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented. | Study participants who received inoculation and were followed on study past Day 0 were included. | Posted | Count of Participants | Participants | Measured through Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Serious Adverse Events (SAEs) | 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 listed above. | Study participants who received inoculation and were followed on study past Day 0 were included. | Posted | Count of Participants | Participants | Measured Day 0 through Day 56 after inoculation and During the RSV Surveillance Season (Date of seasonal pause in enrollment in year of inoculation through March 31) |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer | Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. 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. | Study participants who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included. One study participant in Group 2 withdrew prior to the Day 56 serum collection and is not included in this analysis. | Posted | Count of Participants | Participants | Measured at Day 0 and Day 56 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only) | This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by RT-qPCR. Group 1 participants only. Only participants who met the definition of infection with vaccine virus were included. | Only participants who met the definition of infection with vaccine virus were included. | Posted | Mean | Standard Deviation | log 10 copies/mL | Measured at Days 5, 7, 10, 12 and additional illness visits between Days 0 and 28. |
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Vaccinees Infected With RSV Vaccine Virus in Group 1 | Defined as shedding vaccine virus, detected by RT-qPCR, and/or ≥4-fold rise in RSV-specific serum antibodies, detected by enzyme-linked immunosorbent assay (ELISA) against the RSV F protein and/or an RSV-PRNT from study entry to Study Day 56 | Study participants in Group 1 who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included. | Posted | Count of Participants | Participants | Measured through Day 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent 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 swabs collected during illness visits for MAARI events or a > 2.5-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 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 16 and Table 17 in the protocol document. | Only participants who had RSV detected in nasal swabs or had > 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Two vaccinees were excluded due to withdrawing prior to the completing the RSV surveillance period, and one placebo recipient was excluded due to parent refused to allow collection of the post-surveillance serum sample. Medically Attended Lower Respiratory Illness will be detailed in Secondary Outcome #9 | Posted | Count of Participants | Participants | Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season | The number of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory illness (MAALRI) 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 swabs collected during illness visits for MAALRI events or a ≥ 2.5-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 LRI 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 16 and Table 17 in the protocol document. | Only participants who had RSV detected in nasal swabs or had > 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Two vaccinees were excluded due to withdrawing prior to the completing the RSV surveillance period, and one placebo recipient was excluded due to parent refused to allow collection of the post-surveillance serum sample. | Posted | Count of Participants | Participants | Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG | Serum RSV preF IgG titers and RSV postF IgG titers were assessed by an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a ≥4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points. | Study participants who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included. One study participant in Group 2 withdrew prior to the Day 56 serum collection and is not included in this analysis. | Posted | Count of Participants | Participants | Measured at Day 0 and Day 56 |
|
From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 & 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
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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 | Group 1: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops | 0 | 14 | 1 | 14 | 11 | 14 |
| EG001 | Group 1: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops | 0 | 7 | 0 | 7 | 4 | 7 |
| EG002 | Group 2: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops | 0 | 40 | 0 | 60 | 29 | 40 |
| EG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops | 0 | 20 | 0 | 20 | 14 | 20 |
| EG004 | Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops | 0 | 54 | 1 | 74 | 40 | 54 |
| EG005 | Groups 1 and 2 Combined: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops | 0 | 27 | 0 | 27 | 18 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | During RSV Surveillance Period, wheezing started on Study Day 206. Child hospitalized for 25 hours and diagnosed with RSV. Symptom resolved on Study Day 212. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Croup | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Woods, CRNP-P, CCRP, Manager, RSVPeds Team | Johns Hopkins University Bloomberg School of Public Health | (443) 813-0697 | swoods12@jhu.edu |
| May 12, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Group 1 | Aug 31, 2021 | May 12, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Group 2 | Aug 31, 2021 | May 12, 2025 | ICF_003.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| 6-12 months of age |
|
| 13-18 months of age |
|
| 19-24 months of age |
|
| > 24 months of age |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Upper Respiratory |
|
| Lower Respiratory Illness (LRI) with RSV shedding |
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| LRI in the absence of RSV shedding |
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| Cough without LRI |
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| Otitis media |
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| OG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG004 | Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG005 | Groups 1 and 2 Combined: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
|
|
Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG004 | Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG005 | Groups 1 and 2 Combined: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
|
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| Group 1: Placebo |
Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG002 | Group 2: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG004 | Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG005 | Groups 1 and 2 Combined: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
|
|
|
|
|
|
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops
| OG001 | Group 1: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG002 | Group 2: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG004 | Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG005 | Groups 1 and 2 Combined: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
|
|
| OG001 | Group 1: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG002 | Group 2: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG003 | Group 2: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
| OG004 | Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s | Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10^5 plaque-forming units (PFU); administered as nose drops |
| OG005 | Groups 1 and 2 Combined: Placebo | Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops |
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