Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults

February 9, 2022 updated by: Janssen Vaccines & Prevention B.V.

A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa

The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in healthy children in 2 age strata. The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a post-vaccination phase and long-term follow-up phase until Day 365. Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study. This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1075

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • BoboDioulasso, Burkina Faso
      • Ouagadougou, Burkina Faso
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
      • Toupah/Ousrou, Côte D'Ivoire
  • Kenya
      • Nairobi, Kenya
  • Uganda
      • Entebbe, Uganda
      • Kampala, Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Criteria for healthy adults and elderly participants:

  • Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the hemoglobin is above the age/gender specific limits
  • Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening and immediately prior to each study vaccination
  • A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening
  • Participant must pass the test of understanding (TOU)
  • Participant must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants
  • Participant must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening
  • Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening and having a CD4 positive cell count of >350 cells/microliter. Also participant must be in an otherwise reasonable good medical condition Additional Inclusion Criteria Children Participants
  • Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents and older children, depending on local regulations and practice
  • Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive)
  • Pediatric participants must have received all routine immunizations appropriate for his or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules

Exclusion criteria:

  • Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening
  • Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past
  • Having HIV type 1 or type 2 infection (for healthy adults/elderly/children)
  • Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds)
  • A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination
  • For HIV+ adults, no AIDS-defining illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
Biological: Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
Biological: MVA-BN-Filo
One 0.5 mL IM injection of (1x10*8 infectious units)
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline
Experimental: Group 2
Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 57) or placebo (Day 1/Day 57) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
Biological: Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
Biological: MVA-BN-Filo
One 0.5 mL IM injection of (1x10*8 infectious units)
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline
Experimental: Group 3
Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 85) or placebo (Day 1/Day 85)
Biological: Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
Biological: MVA-BN-Filo
One 0.5 mL IM injection of (1x10*8 infectious units)
Biological: Placebo
One 0.5 mL IM injection of 0.9% saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (Day 29)
Time Frame: Up to 28 days post-dose 1 (Day 29)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up to 28 days post-dose 1 (Day 29)
Number of Participants With Adverse Events (AEs) (28-Day Interval)
Time Frame: Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Adverse Events (56-day Interval)
Time Frame: Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Adverse Events (84-day Interval)
Time Frame: Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
Number of Participants With Adverse Events Post-dose 3 (Day 393)
Time Frame: Up 28 days post-dose 3 (Day 393)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up 28 days post-dose 3 (Day 393)
Number of Participants With Serious Adverse Events
Time Frame: Up to 3 years and 3 months
A serious adverse event (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.
Up to 3 years and 3 months
Number of Participants With Immediate Reportable Events (IREs)
Time Frame: Up to 3 years and 3 months
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Up to 3 years and 3 months
Number of Participants With Solicited Local Adverse Events (Day 8)
Time Frame: 7 days post-dose 1 (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
7 days post-dose 1 (Day 8)
Number of Participants With Solicited Local Adverse Events (28-day Interval)
Time Frame: Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
Time Frame: Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Solicited Local Adverse Events (84-day Interval)
Time Frame: Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Number of Participants With Solicited Local Adverse Events (Day 372)
Time Frame: Up 7 days post-dose 3 (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up 7 days post-dose 3 (Day 372)
Number of Participants With Solicited Systemic Adverse Events (Day 8)
Time Frame: Up to 7 days post-dose 1 (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up to 7 days post-dose 1 (Day 8)
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
Time Frame: Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
Time Frame: Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
Time Frame: Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (Day 372)
Time Frame: Up to 7 days post-dose 3 (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up to 7 days post-dose 3 (Day 372)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay
Time Frame: 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL).
21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Number of Participants With Serious Adverse Events Post-dose 3
Time Frame: Up 28 days post-dose 3 (Day 393)
A serious adverse event (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.
Up 28 days post-dose 3 (Day 393)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Vaccines & Prevention B.V.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Centre Muraz
EBOVAC2 Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR107249
  • VAC52150EBL2002 (Other Identifier: Janssen Vaccines & Prevention B.V.)
  • 2019-000690-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings