Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VAC18195RSV1001 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| 2022-001015-14 | EudraCT Number |
Not provided
Not provided
Not provided
Based on recent study data from VAC18193, it was decided to terminate the study. There are no underlying safety concerns to terminate VAC18195RSV1001
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (>=) 60 years in stable health.
RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-based vaccines. Cohort 1 will assess the safety and reactogenicity of different RSV preF-based vaccines. Cohort 2 is an expansion of cohort 1 and will assess both safety and immunogenicity of these different RSV vaccines. based on C1 and 2 data the optimal vaccine composition will be selected and further evaluated in Cohort 3 and 4 including durability and revaccination. Cohort 3 will accumulate safety data on the selected vaccine and optimize its formulation. Cohort 4 is an expansion of several arms in cohort 3, aimed to understand the durability of the immune response induced by the selected vaccine, and to explore the possibility for revaccination.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in cohort (C) 1 (Group [G] 1) and C 2 through intramuscular injection on Day 1. |
|
| Arm 1b: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1. |
|
| Arm 1c: Placebo | Experimental | Participants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1. |
|
| Arm 2: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. |
|
| Arm 3: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV preF-based Vaccine | Biological | RSV preF-based vaccine will be administered as intramuscular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | From Day 1 up to 6 months post vaccination (up to Day 183) |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs. | From Day 1 up to 6 months post vaccination (up to Day 183) |
| Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Number of participants with solicited local and systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). | 7 days post vaccination (Day 8) |
| Number of Participants With Unsolicited Adverse Events (AEs) | Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant were not specifically questioned in the participant diary. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ark Clinical Research | Long Beach | California | 90815 | United States | ||
| Accel Research Sites |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1*10^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2021 | Dec 12, 2023 |
Not provided
Not provided
Not provided
Not provided
|
| Arm 4: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. |
|
| Arm 5: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. |
|
| Arm 6: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. |
|
| Arm 7: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1. |
|
| Arm 8: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1. |
|
| Arm 9: RSV preF Based Vaccine | Experimental | Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 4) and C 2 through intramuscular injection on Day 1. |
|
| Arm 10: RSV preF Based Vaccine | Experimental | Participants will receive a single dose of selected formulation (based on C 1 and 2 results) in C 3 through intramuscular injection on Day 1. |
|
| Arm 11a: RSV preF Based Vaccine and Placebo | Experimental | Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data C1 and 2) plus placebo on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection. |
|
| Arm 11b: RSV preF Based Vaccine and Placebo | Experimental | Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data from C 1 and 2) plus placebo on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection. |
|
| Arm 12: RSV preF Based Vaccine and Placebo | Experimental | Participants in C 3 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection. |
|
| Arm 13: RSV preF Based Vaccine | Experimental | Participants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection. |
|
| Arm 14: RSV preF Based Vaccine | Experimental | Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection. |
|
| Arm 15: RSV preF Based Vaccine and Placebo | Experimental | Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection. |
|
| Arm 16: RSV preF Based Vaccine and Placebo | Experimental | Participants in C 4 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection. |
|
| Placebo | Drug | Placebo will be administered as intramuscular injection. |
|
| 28 days post vaccination (Day 29) |
| DeLand |
| Florida |
| 32720 |
| United States |
| Floridian Clinical Research LLC | Miami Lakes | Florida | 33016 | United States |
| Heartland Research Associates, an AMR Company | Wichita | Kansas | 67207 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| The Center for Pharmaceutical Research (CPR) | Kansas City | Missouri | 64114 | United States |
| CTI Clinical Trial and Consulting Services | Cincinnati | Ohio | 45212 | United States |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45246 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company | Knoxville | Tennessee | 37920 | United States |
| Tekton Research Inc. | Austin | Texas | 78745 | United States |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg |
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1*10^11 vp and RSV-A.preF protein 150 mcg on Day 1. |
| FG002 | Arm 1c (Cohort 1): Pooled Placebo | Participants received a single IM injection of placebo on Day 1. |
| FG003 | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. |
| FG004 | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 2.5*10^10 vp, Ad26.RSV-B.preF2 2.5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| FG005 | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 5*10^10 vp, Ad26.RSV-B.preF2 5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| FG006 | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| FG007 | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| FG008 | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 5*10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| FG009 | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1.5*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| FG010 | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| Treated (Full Analysis Set) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1*10^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1. |
| BG001 | Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1*10^11 vp and RSV-A.preF protein 150 mcg on Day 1. |
| BG002 | Arm 1c (Cohort 1): Pooled Placebo | Participants received a single IM injection of placebo on Day 1. |
| BG003 | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. |
| BG004 | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 2.5*10^10 vp, Ad26.RSV-B.preF2 2.5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| BG005 | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 5*10^10 vp, Ad26.RSV-B.preF2 5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| BG006 | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| BG007 | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| BG008 | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 5*10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| BG009 | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1.5*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| BG010 | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| BG011 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | From Day 1 up to 6 months post vaccination (up to Day 183) |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) | Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs. | The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | From Day 1 up to 6 months post vaccination (up to Day 183) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Number of participants with solicited local and systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). | The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | 7 days post vaccination (Day 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) | Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant were not specifically questioned in the participant diary. | The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | 28 days post vaccination (Day 29) |
|
From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
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 | Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1*10^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG001 | Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1*10^11 vp and RSV-A.preF protein 150 mcg on Day 1. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | Arm 1c (Cohort 1): Pooled Placebo | Participants received a single IM injection of placebo on Day 1. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG003 | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG004 | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 2.5*10^10 vp, Ad26.RSV-B.preF2 2.5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG005 | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 5*10^10 vp, Ad26.RSV-B.preF2 5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG006 | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. | 0 | 11 | 1 | 11 | 8 | 11 |
| EG007 | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 0 | 11 | 1 | 11 | 11 | 11 |
| EG008 | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 5*10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 0 | 11 | 1 | 11 | 10 | 11 |
| EG009 | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1.5*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG010 | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 0 | 12 | 0 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutrophil Count Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2022 | Dec 12, 2023 | SAP_001.pdf |
| 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 |
|
| OG003 | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. |
| OG004 | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 2.5*10^10 vp, Ad26.RSV-B.preF2 2.5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG005 | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 5*10^10 vp, Ad26.RSV-B.preF2 5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG006 | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| OG007 | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG008 | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 5*10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG009 | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1.5*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| OG010 | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
|
|
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1*10^11 vp and RSV-A.preF protein 150 mcg on Day 1.
| OG002 | Arm 1c (Cohort 1): Pooled Placebo | Participants received a single IM injection of placebo on Day 1. |
| OG003 | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. |
| OG004 | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 2.5*10^10 vp, Ad26.RSV-B.preF2 2.5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG005 | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 5*10^10 vp, Ad26.RSV-B.preF2 5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG006 | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| OG007 | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG008 | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 5*10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG009 | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1.5*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| OG010 | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
|
|
Participants received a single IM injection of placebo on Day 1. |
| OG003 | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. |
| OG004 | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 2.5*10^10 vp, Ad26.RSV-B.preF2 2.5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG005 | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 5*10^10 vp, Ad26.RSV-B.preF2 5 *10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG006 | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| OG007 | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG008 | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 5*10^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
| OG009 | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1.5*10^11 vp and RSV-A.preF protein 300 mcg on Day 1. |
| OG010 | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Participants received single IM injections of Ad26.RSV-A.preF 1*10^11 vp, Ad26.RSV-B.preF2 1*10^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. |
|
|