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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002388-23 | EudraCT Number | ||
| VAC18193RSV3003 | Other Identifier | Janssen Vaccines & Prevention B.V. |
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The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ad26.RSV.PreF-based Vaccine | Experimental | Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot). |
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| Group 2: Ad26.RSV.PreF-based Vaccine | Experimental | Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1). |
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| Group 3: Ad26.RSV.PreF-based Vaccine | Experimental | Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.RSV.PreF-based Vaccine | Biological | Ad26.RSV.PreF-based Vaccine will be administered as single IM injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination | GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported. | 14 days post vaccination on Day 1 (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units. | 14 days post vaccination on Day 1 (Day 15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama Research Center, LLC | Athens | Alabama | 35611 | United States | ||
| Achieve Clinical Research, LLC |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg | Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0*10^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1. |
| 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 | Yes | No | No | Study Protocol | Nov 26, 2021 | Aug 15, 2023 |
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| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination | Number of participants with solicited local AEs 7 days post vaccination 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 were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). | Up to Day 7 post vaccination on Day 1 (up to Day 8) |
| Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination | Number of participants with solicited systemic AEs 7 days post vaccination 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 systemic events include events such as fatigue, headache, nausea, myalgia, and pyrexia, 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). | Up to Day 7 post vaccination on Day 1 (up to Day 8) |
| Number of Participants With Unsolicited AEs for 28 Days Post Vaccination | Number of participants with unsolicited AEs 28 days post vaccination 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 were all AEs for which the participant was not specifically questioned in the participant diary. | Up to 28 days post vaccination on Day 1 (up to Day 29) |
| Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination | Number of participants with SAEs until 6 months post vaccination 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. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) |
| Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination | Number of participants with AESIs until 6 months post vaccination 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI. | From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) |
| Vestavia Hills |
| Alabama |
| 35216 |
| United States |
| Hope Research Institute | Phoenix | Arizona | 85023 | United States |
| Clinical Research Consulting | Milford | Connecticut | 06460 | United States |
| Accel Research Sites | DeLand | Florida | 32720 | United States |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| Suncoast Research Associates, LLC | Miami | Florida | 33173 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| Be Well Clinical Studies | Lincoln | Nebraska | 68516 | United States |
| American Health Network, LLC | Charlotte | North Carolina | 28277 | United States |
| CTI Clinical Trial and Consulting Services | Cincinnati | Ohio | 45212 | United States |
| FG001 | Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 2.5*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
| FG002 | Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
| Vaccinated (Full Analysis Set [FAS]) |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg | Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0*10^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1. |
| BG001 | Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 2.5*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
| BG002 | Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
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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 | Count of Participants | 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination | GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported. | The per-protocol immunogenicity (PPI) set included all randomized participants who received the study vaccine, and for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | ELISA units per liter (EU/L) | 14 days post vaccination on Day 1 (Day 15) |
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| Secondary | Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units. | The PPI set included all randomized participants who received the study vaccine, and for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 14 days post vaccination on Day 1 (Day 15) |
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| Secondary | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination | Number of participants with solicited local AEs 7 days post vaccination 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 were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). | The full analysis set (FAS) included all participants who received study vaccination, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Day 7 post vaccination on Day 1 (up to Day 8) |
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| Secondary | Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination | Number of participants with solicited systemic AEs 7 days post vaccination 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 systemic events include events such as fatigue, headache, nausea, myalgia, and pyrexia, 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 study vaccination, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to Day 7 post vaccination on Day 1 (up to Day 8) |
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| Secondary | Number of Participants With Unsolicited AEs for 28 Days Post Vaccination | Number of participants with unsolicited AEs 28 days post vaccination 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 were all AEs for which the participant was not specifically questioned in the participant diary. | The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | Up to 28 days post vaccination on Day 1 (up to Day 29) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination | Number of participants with SAEs until 6 months post vaccination 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. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) |
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| Secondary | Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination | Number of participants with AESIs until 6 months post vaccination 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI. | The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) |
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From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
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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: Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg | Participants received adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26. RSV.preF) 1.0*10^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) mixture-based vaccine (Ad26/protein preF RSV) as intramuscular (IM) injection on Day 1. | 1 | 250 | 5 | 250 | 0 | 250 |
| EG001 | Group 2: Ad26.RSV.preF 2.5*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 2.5*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. | 0 | 251 | 4 | 251 | 0 | 251 |
| EG002 | Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. | 1 | 251 | 7 | 251 | 0 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Drug Withdrawal Syndrome | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
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| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Lung Squamous Cell Carcinoma Stage Iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
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| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
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| Focal Dyscognitive Seizures | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Peroneal Nerve Palsy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Alcohol Abuse | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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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 | |
|---|---|---|---|---|
| Director Biomarkers Viral Vaccines | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2022 | Aug 15, 2023 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
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Participants received Ad26.RSV.preF 2.5*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
| OG002 | Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
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|
Participants received Ad26.RSV.preF 2.5*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1.
| OG002 | Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
|
|
| Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg |
Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
|
|
| OG002 | Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg | Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
|
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| Group 3: Ad26.RSV.preF 1.0*10^10 vp + RSV preF Protein 150 mcg |
Participants received Ad26.RSV.preF 1.0*10^10 vp and RSV.preF protein 150 mcg mixture-based vaccine (Ad26/protein preF RSV) as IM injection on Day 1. |
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