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    Summary
    EudraCT Number:2019-000691-42
    Sponsor's Protocol Code Number:VAC52150EBL3001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-000691-42
    A.3Full title of the trial
    A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola
    A.4.1Sponsor's protocol code numberVAC52150EBL3001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02509494
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/116/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportLondon School of Hygiene and Tropical Medicine
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportCollege of Medicine and Allied Health Sciences
    B.4.2CountrySierra Leone
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAd26.ZEBOV
    D.3.2Product code JNJ-61210474
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeJNJ-61210474
    D.3.9.3Other descriptive nameAD26.ZEBOV
    D.3.9.4EV Substance CodeSUB169588
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMVA-BN-Filo
    D.3.2Product code JNJ-63839880
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeMVA-mBN226B; JNJ-63839880
    D.3.9.3Other descriptive nameMVA-BN-FILO
    D.3.9.4EV Substance CodeSUB169589
    D.3.10 Strength
    D.3.10.1Concentration unit titre titre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMenACWY
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenACWY
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP A, C, W135 AND Y CONJUGATE VACCINE
    D.3.9.4EV Substance CodeSUB31085
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Ebola virus disease
    E.1.1.1Medical condition in easily understood language
    Prevention of Ebola virus disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014071
    E.1.2Term Ebola disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Stage 1 is:
    • To evaluate the safety of a heterologous prime-boost regimen utilizing Ad26.ZEBOV and MVA-BN-Filo given at a 56-day interval.

    The primary objective of Stage 2 is:
    • To evaluate the safety of a heterologous prime-boost regimen utilizing Ad26.ZEBOV and MVA-BN-Filo given at a 56-day interval compared to an active control vaccine.
    E.2.2Secondary objectives of the trial
    The secondary objective of Stage 1 is:
    • To assess humoral immune responses to a heterologous prime-boost regimen utilizing Ad26.ZEBOV and MVA-BN-Filo as measured by an enzyme-linked immunosorbent assay (ELISA) at 21 days post-boost vaccination.
    • To assess the safety and tolerability of a third vaccination using Ad26.ZEBOV administered at least 2 years post prime.

    The secondary objective of Stage 2 is:
    • To assess humoral immune responses to a heterologous prime-boost regimen utilizing Ad26.ZEBOV and MVA-BN-Filo as measured by an ELISA at 21 days post boost vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stage 1
    1. Documented community engagement by a community leader must be available. At the individual level, each subject must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. In case the subject cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved in the conduct of the study.
    2. Must be a male or female subject aged 18 years or older at screening.
    3. Must be resident in the selected study community, with no intention to move from the study area within the next 5 months.
    4. Must be healthy on the basis of physical examination and clinical laboratory tests performed at screening. Subjects must meet the following laboratory criteria within 28 days before Day 1:
    • Hemoglobin: women: ≥12.5 g/dL; men ≥13.0 g/dL
    • Hematocrit: ≥36%
    • Red blood cell (RBC) count: ≥4,500,000/mm^3
    • White blood cell (WBC) count: ≥4,000/mm^3
    • Platelets: ≥150,000/mm^3
    • Alanine aminotransferase (ALT): ≤69 U/L
    • Aspartate aminotransferase (AST): ≤46 U/L
    • Creatinine: <109 µmol/L
    5. Female subjects of childbearing potential must use adequate birth control measures consistent with local regulations regarding the use of birth control for subjects participating in clinical studies from at least 14 days before the prime vaccination, with a negative urine β-hCG pregnancy test at screening and immediately prior to the prime vaccination, which shall occur no earlier than 14 days after the screening visit.
    6. Male subjects who are sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment.
    7. Must pass the test of understanding (TOU).

    Stage 2
    8. Documented community engagement by a community leader must be available. At the individual level, adult subjects (aged 18 years and older at screening) must sign an ICF indicating that he or she understands the purpose of the study and the procedures required for the study and is willing to participate in the study. In case the subject cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved in the conduct of the study. In case the subject’s age is below the legal cut-off age for consent (according to local regulations), the parent/legal guardian will be asked to give consent, and the subject will be informed about the study. Subjects aged 7 years and older will be asked to give positive assent. The assent procedure must be witnessed by an adult literate parent/legal guardian/third party not involved in the conduct of the study, and documented.
    9. Must be a male or female subject aged 1 year or older at screening.
    10. Must be resident in the selected study community, with no intention to move from the study area during the subject's participation in the study.
    11. Must be healthy on the basis of physical examination and clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the institutional normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
    12. Sexually active female subjects of childbearing potential must use adequate birth control measures consistent with the local standards regarding the use of birth control for subjects participating in clinical studies and what is available from at least 14 days before the prime vaccination, with a negative urine β-hCG pregnancy test at screening and immediately prior to the prime vaccination, which shall occur no earlier than 14 days after the screening visit.
    13. Male subjects who are sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment.
    14. Subjects or the parent/legal guardian (for children) must pass the TOU.
    E.4Principal exclusion criteria
    Stage 1
    1. Women who are breast-feeding or known to be pregnant. A pregnancy test will be performed at screening in women of childbearing potential.
    2. Subjects who have an illness prior to vaccination. This does not include acute illnesses such as diarrhea or mild upper respiratory tract infection unless accompanied by body temperature >37.5°C.
    3. Subjects with any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation. Subjects who identify themselves as being HIV-positive can be included as long as their general condition is good, ie, they are on antiretroviral treatment or have no signs or symptoms of immune incompetence.
    4. Subjects with anemia (defined as hemoglobin <10 g/dL).
    5. Subjects who have had a previous adverse reaction to vaccination excluding mild non-systemic adverse reactions.
    6. Subjects who are being treated with an immunosuppressive drug at the time of screening.
    7. Subjects who have received a blood transfusion or other blood products within 8 weeks of vaccination.
    8. Subjects who have been vaccinated with a candidate Ebola vaccine or have participated in another Ebola preventative or therapeutic biomedical intervention study.
    9. Subjects who have been vaccinated with live-attenuated vaccines within 30 days before the prime vaccination, and with inactivated vaccines within 15 days before the prime vaccination.
    10. Subjects who are known to have received any Ad26- or MVA-based candidate vaccine in the past.
    11. Subjects who have been diagnosed with EVD or are under quarantine/have been exposed to Ebola.
    12. Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the full course of vaccination and observation.
    13. Fever (body temperature ≥38.0°C). Temperature will be taken according to standardized temperature monitoring as per Ebola response regulations. Subjects with a fever of ≥38.0°C will be referred to the EVD assessment services.

    Stage 2
    1. Women who are breast-feeding or known to be pregnant. A pregnancy test will be performed at screening in women of childbearing potential.
    2. Subjects who have an illness prior to vaccination. This does not include acute illnesses such as diarrhea or mild upper respiratory tract infection unless accompanied by body temperature ≥38.0° C.
    3. Subjects with any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation. Subjects who identify themselves as being HIV positive can be included as long as their general condition is good, ie, they are on antiretroviral treatment or have no signs or symptoms of immune incompetence, diagnosed on the basis of physical examination, medical history, and the investigator’s clinical judgment.
    4. Subjects with anemia (defined as hemoglobin <8 g/dL for children aged ≥1 to <5 years, <9 g/dL for children aged ≥5 to <15 years, and <10 g/dL for subjects aged ≥15 years).
    5. Subjects who have had a previous adverse reaction to vaccination excluding mild nonsystemic adverse reactions.
    6. Subjects who are being treated with an immunosuppressive drug at the time of screening.
    7. Subjects who have received a blood transfusion or other blood products within 8 weeks of vaccination.
    8. Subjects who have been vaccinated with a candidate Ebola vaccine or have participated in another Ebola preventative or therapeutic biomedical intervention study.
    9. Subjects who have been vaccinated with live-attenuated vaccines within 30 days before the prime vaccination, and with inactivated vaccines within 15 days before the prime vaccination.
    10. Subjects who are known to have received any Ad26- or MVA-based candidate vaccine in the past.
    11. Subjects who have been diagnosed with EVD or are under quarantine/have been exposed to Ebola.
    12. Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the full course of vaccination and observation.
    13. Children with weight-per-height below 10th percentile according to the WHO (1- and 2- year-olds) and Centers for Disease Control and Prevention (CDC) growth charts (3- to 11-year-olds).
    14. Fever (body temperature ≥38.0° C). Temperature will be taken according to standardized temperature monitoring as per Ebola local response regulations. Subjects with a fever of ≥38.0° C will be referred to routine medical follow-up.
    15. Subjects who have received a meningitis vaccine in the past.
    E.5 End points
    E.5.1Primary end point(s)
    1. Solicited local and systemic adverse events (reactogenicity), collected until 7 days after the prime and boost vaccination (Stage 1 and Stage 2) and the third vaccination (Stage 1) as recorded by the subjects (or, when appropriate, by a project field worker, a caregiver, surrogate, or the subject's legally acceptable representative) in a diary during daily home contacts with a project field worker.
    2. Solicited local and systemic adverse events (reactogenicity), collected until 60 minutes after the prime and boost vaccination and until 30 minutes after the third vaccination in all subjects from Stage 1, and until 30 minutes after each vaccine administration in all subjects from Stage 2.
    3. Unsolicited adverse events, collected by the investigator or the clinical designee from provision of informed consent onwards until 56 days after the boost vaccination in Stage 1 and then again from the day of the third vaccination until 28 days after the third vaccination, and from provision of informed consent onwards until 28 days after the prime vaccination in Stage 2 and then again until 28 days after the boost vaccination.
    4. Serious adverse events, including deaths, and immediate reportable events (IREs) collected in all subjects from Stage 1 and Stage 2 from provision of informed consent onwards until the subject’s last study visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Until 7 days after the prime and boost vaccination (Stage 1 and Stage 2) and the third vaccination (Stage 1)
    2. Until 60 minutes after the prime and boost vaccination and until 30 minutes after the third vaccination in all subjects from Stage 1, and until 30 minutes after each vaccine administration in all subjects from Stage 2
    3. Until 56 days after the boost vaccination in Stage 1 and then again from the day of the third vaccination until 28 days after the third vaccination, and from provision of informed consent onwards until 28 days after the prime vaccination in Stage 2 and then again until 28 days after the boost vaccination
    4. From Stage 1 and Stage 2 from provision of informed consent onwards until the subject’s last study visit
    E.5.2Secondary end point(s)
    Evaluation of antibody responses depending on assay and/or sample availability any of the following assays
    • EBOV GP ELISA: to determine the binding antibody levels elicited by vaccination.
    • VNA: neutralizing antibody reactivity against the EBOV GP defined as the serum titer that is able to inhibit viral infection by a certain percentage (IC50,IC80 or IC90).
    • ELISA, VNA, and/or PRNT: to explore the binding and/or neutralizing antibody responses against the adenovirus and/or MVA vector.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Staged study with an open-label uncontrolled Stage 1 and a double-blinded controlled Stage 2
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Sierra Leone
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 577
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 66
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 319
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 192
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 441
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1022
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Upon completion of the study, sites may offer MenACWY to the Ad26.ZEBOV/MVA-BN-Filo arm and the Ad26.ZEBOV/MVA-BN-Filo vaccine (if licensed and/or WHO-prequalified) to the control arm upon consultation with the health authorities.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Sierra Leone
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