| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004139-11 | EudraCT Number | ||
| VAC52150EBL4001 | Other Identifier | Janssen Vaccines & Prevention B.V. |
Not provided
Not provided
Not provided
Due to the pandemic with only one participant in follow up, as the impact on the safety was determined to be negligible, the study was terminated early.
Not provided
| Name | Class |
|---|---|
| Bavarian Nordic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.
This is a multi-country, prospective, long-term clinical safety study for collection of serious adverse events and pregnancy outcomes following administration of Ad26.ZEBOV and/or MVA-BN-Filo vaccines among participants who were enrolled in Phase 1, 2 or 3 clinical studies. The safety data will be collected in 3 cohorts; Cohort 1- adult and pediatric participants that received Ad26.ZEBOV and/or MVA-BN-Filo in Phase 1, 2 or 3 clinical studies (adults, adolescents and children), Cohort 2- Female participants who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV will be followed to the end of their pregnancy for pregnancy outcomes (Cohort 2). After the end of pregnancy, female participants will continue to be followed in Cohort 1. Cohort 3 - children born to female participants exposed to Ad26.ZEBOV and/or MVA-BN-Filo who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV. Safety data will be collected on all consenting participants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed to Ad26.ZEBOV and/or MVA-BN Filo | Experimental | Safety Data will be collected from participants who received Ad26.ZEBOV and/or MVA-BN-Filo in Phase 1, 2 or 3 clinical studies in 6-month intervals up to 60 months after prime vaccination, including the duration in the participant's original study (Cohort 1). Female participants who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV will be followed to the end of their pregnancy for pregnancy outcomes (Cohort 2). After the end of pregnancy, female participants will continue to be followed in Cohort 1. Safety Data for live born children to female participants will be followed up to 60 months after birth (Cohort 3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.ZEBOV | Biological | No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to Ad26.ZEBOV vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs) | An adverse event (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 the intervention. 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. | Up to 60 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Rockville | Maryland | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38400193 | Derived | Puri A, Pollard AJ, Schmidt-Mutter C, Laine F, PrayGod G, Kibuuka H, Barry H, Nicolas JF, Lelievre JD, Sirima SB, Kamala B, Manno D, Watson-Jones D, Gaddah A, Keshinro B, Luhn K, Robinson C, Douoguih M; EBL4001 Study Group. Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study. Vaccines (Basel). 2024 Feb 17;12(2):210. doi: 10.3390/vaccines12020210. |
Not provided
Not provided
As none of the participants met Cohort 2 eligibility criteria pre-specified in the protocol, therefore no participants were enrolled in Cohort 2. So the results were only presented for Cohorts 1 and 3.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Ad26.ZEBOV + MVA-BN-Filo | Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration). |
| 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 | Mar 2, 2017 | Dec 14, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MVA-BN-Filo | Biological | No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to MVA-BN-Filo vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth. |
|
| BoboDioulasso |
| Burkina Faso |
| Ouagadougou | Burkina Faso |
| Créteil | France |
| Paris | France |
| Pierre-Bénite | France |
| Rennes | France |
| Saint-Etienne | France |
| Strasbourg | France |
| Tours | France |
| Nairobi | Kenya |
| Mwanza | Tanzania |
| Entebbe | Uganda |
| Kampala | Uganda |
| London | United Kingdom |
| Oxford | United Kingdom |
| FG001 | Cohort 1: Placebo | Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration). |
| FG002 | Cohort 3: Ad26.ZEBOV + MVA-BN-Filo | Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth. |
| FG003 | Cohort 3: Placebo | Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth. |
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all participants who were enrolled in this study and had at least one post-baseline visit, regardless of the occurrence of protocol deviations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Ad26.ZEBOV + MVA-BN-Filo | Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration). |
| BG001 | Cohort 1: Placebo | Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration). |
| BG002 | Cohort 3: Ad26.ZEBOV + MVA-BN-Filo | Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth. |
| BG003 | Cohort 3: Placebo | Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, 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 | Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs) | An adverse event (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 the intervention. 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. | Full analysis set (FAS) included all participants who were enrolled in this study and had at least one post-baseline visit, regardless of the occurrence of protocol deviations. | Posted | Count of Participants | Participants | Up to 60 months |
|
|
|
Cohorts 1 and 3: Up to 60 months
FAS included all participants who were enrolled in this study and had at least one post-baseline visit, regardless of the occurrence of protocol deviations. As per planned analysis of this study, the objective of this study was to collect only serious adverse events (SAEs) and other adverse events (Non-serious AEs) were not collected and analyzed in this study, hence only SAEs have been reported and presented in this study.
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 | Cohort 1: Ad26.ZEBOV + MVA-BN-Filo | Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration). | 0 | 614 | 49 | 614 | 0 | 0 |
| EG001 | Cohort 1: Placebo | Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration). | 0 | 53 | 1 | 53 | 0 | 0 |
| EG002 | Cohort 3: Ad26.ZEBOV + MVA-BN-Filo | Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth. | 0 | 2 | 2 | 2 | 0 | 0 |
| EG003 | Cohort 3: Placebo | Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth. | 0 | 1 | 1 | 1 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Medical Device Discomfort | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Chronic Sinusitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Typhoid Fever | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Extradural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skull Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Parathyroid Tumour Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Carotid Artery Dissection | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cerebral Venous Thrombosis | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cervicobrachial Syndrome | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Meningism | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Miller Fisher Syndrome | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Small Fibre Neuropathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blighted Ovum | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Caesarean Section | Surgical and medical procedures | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
Not provided
As none of the participants met Cohort 2 eligibility criteria pre-specified in the protocol, therefore no participants were enrolled in Cohort 2. So the results were only presented for Cohorts 1 and 3.
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. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| 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 | Feb 21, 2022 | Dec 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| D006482 | Hemorrhagic Fevers, Viral |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018702 | Filoviridae Infections |
| D018701 | Mononegavirales Infections |
Not provided
Not provided
| 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 |
|
| FRANCE |
|
| KENYA |
|
| TANZANIA, UNITED REPUBLIC OF |
|
| UGANDA |
|
| UNITED KINGDOM |
|
| UNITED STATES OF AMERICA |
|