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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001345-27 | EudraCT Number | ||
| VAC18194RSV2001 | Other Identifier | Janssen Vaccines & Prevention B.V. |
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The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.
The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 0: Adults (Ad26.RSV.preF) | Experimental | Participants aged greater than or equal to (>=) 18 to lesser than or equal to (<=) 50 years will receive vector Ad26.RSV.preF at 1*10^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29. |
|
| Cohort 0: Adults (Placebo) | Placebo Comparator | Participants aged >= 18 to <= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29. |
|
| Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF) | Experimental | RSV seropositive participants aged >=12 to <=24 months will receive Ad26.RSV.preF at 5*10^10 vp via IM route (Group 3) on Day 1 and 29. |
|
| Cohort 1: RSV seropositive Toddlers (Placebo) | Placebo Comparator | RSV seropositive participants aged >= 12 to <= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Biological | Participants will receive two doses of 0.5 milliliter (mL) (1*10^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. 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 included erythema, swelling/induration, and pain/tenderness. | For 7 days after first vaccination on Day 1 (Up to Day 7) |
| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. 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 included erythema, swelling/induration, and pain/tenderness. | For 7 days after second vaccination on Day 29 (Up to Day 35) |
| Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C). | For 7 days after first vaccination on Day 1 (Up to Day 7) |
| Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. | Day 1 (predose), Post-dose on Days 29, 57 and 211 |
| Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 |
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Inclusion Criteria:
Adults Participants:
Pediatric Participants:
Exclusion Criteria:
Adults Participants:
Pediatric Participants:
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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 |
|---|---|---|---|---|---|---|
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States | ||
| Järvenpään rokotetutkimusklinikka |
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 | Cohort 0 (Adults): Ad26.RSV.preF | Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29. |
| 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 | Apr 18, 2019 | Apr 19, 2023 |
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|
| Ad26.RSV.preF (5*10^10 vp) | Biological | RSV seropositive participants will receive two doses of 0.25 mL (5*10^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF. |
|
|
| Placebo | Drug | Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29. |
|
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C).
| For 7 days after second vaccination on Day 29 (Up to Day 35) |
| Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary. | For 28 days after first vaccination on Day 1 (Up to Day 28) |
| Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary. | For 28 days after second vaccination on Day 29 (Up to Day 56) |
| Number of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. 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 (post-vaccination) to end of the study (up to 2 years 4 months) |
GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported. |
| Pre-fusion on Days 1, 29, 57 and 211 |
| Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported. | Post-fusion on Days 1, 29, 57 and 211 |
| Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines. | Day 1 (predose) and Post-dose on Days, 29, and 57 |
| Jarvenpaa |
| 04400 |
| Finland |
| University of Tampere/Vaccine Research Center | Tampere | 33100 | Finland |
| University of Tampere/Vaccine Research Center | Turku | 20520 | Finland |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
| Oxford Vaccine Group | Oxford | OX3 7LE | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO166YD | United Kingdom |
| FG001 |
| Cohort 0 (Adults): Placebo |
Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29. |
| FG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| FG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 0 (Adults): Ad26.RSV.preF | Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29. |
| BG001 | Cohort 0 (Adults): Placebo | Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29. |
| BG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| BG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
| BG004 | 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | 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 | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. 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 included erythema, swelling/induration, and pain/tenderness. | The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. | Posted | Count of Participants | Participants | For 7 days after first vaccination on Day 1 (Up to Day 7) |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. 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 included erythema, swelling/induration, and pain/tenderness. | The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | For 7 days after second vaccination on Day 29 (Up to Day 35) |
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| Primary | Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C). | The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. | Posted | Count of Participants | Participants | For 7 days after first vaccination on Day 1 (Up to Day 7) |
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| Primary | Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature >=38 degree celsius [°C]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature >=38 °C). | The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | For 7 days after second vaccination on Day 29 (Up to Day 35) |
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| Primary | Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary. | The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. | Posted | Count of Participants | Participants | For 28 days after first vaccination on Day 1 (Up to Day 28) |
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| Primary | Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary. | The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | For 28 days after second vaccination on Day 29 (Up to Day 56) |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. 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 safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. | Posted | Count of Participants | Participants | From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months) |
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| Secondary | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. | The Per-protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 1 (predose), Post-dose on Days 29, 57 and 211 |
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| Secondary | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | GMT (ELISA units per liter [EU/L]) of RSV F protein in pre-fusion form as assessed by ELISA was reported. | The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | EU/L | Pre-fusion on Days 1, 29, 57 and 211 |
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| Secondary | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | GMT (ELISA units per liter [EU/L]) of RSV F protein in post-fusion form as assessed by ELISA was reported. | The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | EU/L | Post-fusion on Days 1, 29, 57 and 211 |
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| Secondary | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines. | PPI set: all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact immunogenicity outcomes. 'N' (number of participants analyzed)=number of participants who were evaluable for this outcome measure, 'n' (number analyzed)=number of participants evaluable at specified timepoint and '0' in number analyzed field=none of participants were applicable for evaluation at specified time point. | Posted | Median | Inter-Quartile Range | Percentage of cytokine cell subsets | Day 1 (predose) and Post-dose on Days, 29, and 57 |
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From Day 1 (post-vaccination) up to end of the study (up to 2 years 4 months)
The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
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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 | Cohort 0 (Adults): Ad26.RSV.preF | Adult participants aged greater than or equal to (>=) 18 years to less than or equal to (<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1*10^11 viral particles (vp) on Day 1 and Day 29. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG001 | Cohort 0 (Adults): Placebo | Adult participants aged >=18 years to <=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1*10^11 vp) on Day 1 and Day 29. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. | 0 | 24 | 1 | 24 | 19 | 24 |
| EG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. | 0 | 12 | 2 | 12 | 10 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Allergy to Animal | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Anal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Body Tinea | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Enterovirus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hand-Foot-And-Mouth Disease | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Bacterial Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tinea Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Viral Rash | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Heart Rate Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Influenza B Virus Test Positive | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Lymphocyte Count Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Respiratory Syncytial Virus Test Positive | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Physician | Janssen Vaccines and Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2018 | Apr 19, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| OG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
| OG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
| OG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
| OG002 |
| Cohort 1 (Toddlers): Ad26.RSV.preF |
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
| OG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
|
| OG002 | Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory syncytial virus (RSV) seropositive toddler participants aged >=12 to <=24 months received a single IM injection of Ad26.RSV.preF at dose of 5*10^10 vp on Day 1 and Day 29. |
| OG003 | Cohort 1 (Toddlers): Placebo | RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5*10^10 vp) on Day 1 and Day 29. |
|
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