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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: RSV 6120/∆NS1 Vaccine | Experimental | 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. |
|
| Group 1: RSV 6120/F1/G2/∆NS1 Vaccine | Experimental | 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. |
|
| Group 1: Placebo | Placebo Comparator | 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. |
|
| Group 2: RSV 6120/∆NS1 Vaccine | Experimental | 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. |
|
| Group 2: RSV 6120/F1/G2/∆NS1 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV 6120/∆NS1 | Biological | Delivered as nose drops |
|
| 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. |
| 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. |
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INCLUSION CRITERIA FOR RSV-SEROPOSITIVE CHILDREN
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:
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:
Scheduled administration of any of the following after planned inoculation:
Receipt of any of the following medications within 3 days of study enrollment:
Any of the following events at the time of enrollment:
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
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:
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:
Scheduled administration of any of the following after planned inoculation
Receipt of any of the following medications within 3 days of study enrollment:
Any of the following events at the time of enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth A. Karron, MD | Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University Center for Immunization Research | Baltimore | Maryland | 21205 | United States |
Of the 100 participants that were screened, 60 met eligibility criteria, parent agreed to enroll and were inoculated with study product.
Participants were recruited from pediatric practices and clinics in the greater Baltimore/Washington area based on referral by the primary care provider or the provider's staff; and through mailing IRB-approved documents to children of local pediatric practices and clinics, and to households in local zip codes containing age-appropriate children between April 2018 and October 2023. The first participant was enrolled on 06/29/2018 and the last participant was enrolled on 10/20/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. RSV 6120/∆NS1: Delivered as nose drops |
| FG001 | Group 1: RSV 6120/F1/G2/∆NS1 Vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 5, 2023 |
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| Group 2: Placebo | Placebo Comparator | 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. |
|
| RSV 6120/F1/G2/∆NS1 | Biological | Delivered as nose drops |
|
| Placebo | Biological | Delivered as nose drops |
|
| 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:
| 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:
| 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 |
| 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) |
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. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| FG002 | 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. Placebo: Delivered as nose drops |
| FG003 | 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. RSV 6120/∆NS1: Delivered as nose drops |
| FG004 | 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. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| FG005 | 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. Placebo: Delivered as nose drops |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. RSV 6120/∆NS1: Delivered as nose drops |
| BG001 | 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. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| BG002 | 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. Placebo: Delivered as nose drops |
| BG003 | 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. RSV 6120/∆NS1: Delivered as nose drops |
| BG004 | 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. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| BG005 | 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. Placebo: Delivered as nose drops |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||
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| Primary | 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. | Study participants who were immunized were included. | Posted | Count of Participants | Participants | Measured through Day 10 |
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| Primary | 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. | Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured through Day 28 |
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| Primary | 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. | Study participants who were immunized were included. | Posted | Count of Participants | Participants | Measured through Day 10 |
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| Primary | 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. | Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured through Day 28 |
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| Primary | 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:
| Study participants who were immunized were included. | Posted | Count of Participants | Participants | Measured through Day 28 |
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| Primary | 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:
| Study participants who received were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens during the acute phase. | Posted | Count of Participants | Participants | Measured through Day 56 |
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| Primary | 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. | Study participants who were immunized were included. | Posted | Count of Participants | Participants | Measured through Day 28 |
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| Primary | 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. | Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured through Day 56 |
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| Primary | 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. | Study participants who were immunized were included. Only participants who met the definition of infection with vaccine virus were included. | Posted | Measured at Days 0,3,4,5,6,7 and 10. |
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| Primary | 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. | Study participants who were immunized were included. Data from one Group 2 RSV 6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens during the acute phase. | Posted | Mean | Standard Deviation | log 10 PFU/mL | Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28 |
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| Primary | Duration of Virus Shedding in Nasal Washes (RSV-seropositive Participants) | As determined by a) culture and b) reverse transcription polymerase chain reaction (rRT-PCR) | Study participants who were immunized were included. Virus shedding was not detected by culture or qPCR. | Posted | Measured at Days 0, 3, 4, 5, 6, 7 and 10 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Study participants who were immunized were included. Only participants who met the definition of infection with vaccine virus were included. Data from one Group 2 RSV 6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase. | Posted | Mean | Full Range | Days | Measured at Days 0,3,5,7,10,12,14,17 and 28. Last day positive is reported. |
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| Primary | 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. | Study participants who were immunized were included. | Posted | Count of Participants | Participants | Measured at Day 0 and Day 28 |
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| Primary | 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. | Study participants who were immunized were included. Data from one Group2 RSV 6120/DNS1 vaccinee and one placebo recipient excluded from analysis because wild-type (wt) -RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured through Day 56 |
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| Primary | 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. | Study participants who were immunized were included. | Posted | Mean | Standard Deviation | log 2 titers | Measured through Day 28 |
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| Primary | 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. | Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase. | Posted | Mean | Standard Deviation | log 2 titers | Measured through Day 56 |
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| Primary | 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. | Study participants who were immunized were included | Posted | Count of Participants | Participants | Day 0 through the 28th day following inoculation |
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| Secondary | 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. | Participants who had RSV detected in nasal specimens or had > or = to 4-fold rise in serum antibodies pre-to post-RSV season in absence of RSV-associated medical events were included. 6 RSV 6120/∆NS1 vaccinees, 4 6120/F1/G2/∆NS1 vaccinees and 2 placebo recipients were excluded due to SARS-CoV-2 pandemic & no post-surveillance sample.1 Group 2 RSV 6120/DNS1 vaccinee and 1 placebo recipient were excluded from analysis because wt-RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study |
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| Secondary | 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. | Participants who had RSV detected in nasal specimens or had >or= to 4-fold rise in serum antibodies pre-to post-RSV season in absence of RSV-associated medical events were included. 6 RSV 6120/DNS1 vaccinees, 4 RSV 6120/F1/G2/DNS1 vaccinees & 2 placebo recipients were excluded due to SARS-CoV-2 pandemic & no post-surveillance sample. 1 Group 2 RSV 6120/DNS1 vaccinee &1 placebo recipients were excluded from analysis because wt-RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study |
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| Secondary | 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. | Participants who had RSV detected in nasal specimens or had >or= to 4-fold rise in serum antibodies pre-to post- RSV season in the absence of RSV-associated medical events were included. 6 RSV 6120/DNS1, 5 RSV 6120/F1/G2/DNS1 & 2 placebo recipients were excluded due to SARS-CoV-2 pandemic & no post-surveillance sample. 1 Group 2 RSV 6120/DNS1 vaccinee and 1 placebo recipient were excluded from analysis because wt-RSV was detected in nasal specimens collected during the acute phase of the study. | Posted | Mean | Standard Deviation | log 2 titers | Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study |
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| Secondary | 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 | Only participants who had 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 were included. Six RSV 6120/DNS1, 5 RSV 6120/DNS1/F1/G2, 2 placebo recipients were excluded due to no post-surveillance serum sample due to SARS-CoV-2. One Group 2 RSV 6120/DNS1vaccinee and one placebo recipient were excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase. | Posted | Count of Participants | Participants | Measured pre-RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline) |
|
From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1, and between 6 and 10 months for Group 2 depending on time of enrollment.
Group 1 Day 0-28 all SAEs & Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 & 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 & 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
Not provided
| 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 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. RSV 6120/∆NS1: Delivered as nose drops | 0 | 10 | 0 | 10 | 4 | 10 |
| EG001 | 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. RSV 6120/F1/G2/∆NS1: Delivered as nose drops | 0 | 10 | 0 | 10 | 6 | 10 |
| EG002 | 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. Placebo: Delivered as nose drops | 0 | 5 | 0 | 10 | 2 | 5 |
| EG003 | 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. RSV 6120/∆NS1: Delivered as nose drops | 0 | 13 | 0 | 13 | 11 | 13 |
| EG004 | 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. RSV 6120/F1/G2/∆NS1: Delivered as nose drops | 0 | 14 | 0 | 14 | 9 | 14 |
| EG005 | 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. Placebo: Delivered as nose drops | 0 | 6 | 0 | 6 | 4 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Two or more consecutive days of clear or purulent discharge from the nares. Note: Not associated with crying, change of room temperature, or eating and drinking. |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Pharyngeal erythema accompanied by exudate or pharyngeal erythema with enlarged, tender lymph nodes. Note: May be associated with sore throat, or painful or difficult swallowing |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Two or more consecutive days of 3 or more episodes of cough during a 15-minute timed observation period, or cough awakens child from sleep. Note: Not associated with eating, drinking or choking. |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA | Systematic Assessment | Loss of tympanic membrane landmarks, accompanied by erythema and loss of mobility. May or may not be associated with fever or other respiratory symptoms. Confirmed with tympanometry if possible |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment | Temporal or rectal temperatures ≥100.4oF |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Croup | Infections and infestations | MedDRA | Systematic Assessment | Barking cough, hoarseness, and inspiratory stridor. |
|
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth A. Karron, MD | Johns Hopkins Bloomberg School of Public Health (JHSPH) | 410-614-0319 | rkarron@jhu.edu |
| Jan 16, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: RSV-seronegative | Aug 8, 2023 | Jul 7, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: RSV-seropositive | Jun 5, 2018 | Jul 7, 2025 | ICF_002.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
| 1 year of age |
|
| 2 years of age |
|
| 3 years of age |
|
| 4 years of age |
|
| >4 years 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 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Upper Respiratory Illness (URI) |
|
| Lower Respiratory Illness (LRI) with RSV shedding |
|
| LRI in the absence of RSV shedding |
|
| Cough without LRI |
|
| Otitis Media |
|
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
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.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
| OG001 |
| Group 2: RSV 6120/F1/G2/∆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/F1/G2/∆NS1 vaccine at Day 0. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
|
|
| 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. Placebo: Delivered as nose drops |
|
|
|
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.
Placebo: Delivered as nose drops
|
|
| Units | Counts |
|---|---|
| Participants |
|
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.
Placebo: Delivered as nose drops
|
|
|
|
| OG002 |
| 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. Placebo: Delivered as nose drops |
|
|
|
|
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. Placebo: Delivered as nose drops |
|
|
|
|
| OG001 | Group 2: RSV 6120/F1/G2/∆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/F1/G2/∆NS1 vaccine at Day 0. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
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. RSV 6120/∆NS1: Delivered as nose drops |
| OG001 | Group 2: RSV 6120/F1/G2/∆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/F1/G2/∆NS1 vaccine at Day 0. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
| OG001 | Group 2: RSV 6120/F1/G2/∆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/F1/G2/∆NS1 vaccine at Day 0. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
| OG001 | Group 2: RSV 6120/F1/G2/∆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/F1/G2/∆NS1 vaccine at Day 0. RSV 6120/F1/G2/∆NS1: Delivered as nose drops |
| OG002 | 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. Placebo: Delivered as nose drops |
|
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|
| Grade 2* |
|
| Grade 3* |
|
| Grade 4* |
|