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    Clinical Trial Results:
    A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone

    Summary
    EudraCT number
    		 2021-001331-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2023
    First version publication date
    21 May 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC52150EBL2005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03929757
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Newtonweg 1, CP Leiden, Netherlands, 2333
    Public contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to assess the safety and reactogenicity of a heterologous 2-dose regimen utilising adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) (first vaccination; Dose 1) and Modified Vaccinia Ankara Bavarian Nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) (second vaccination; Dose 2) administered intramuscular(ly) (IM) on Days 1 and 57, respectively.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Guinea: 53
    Country: Number of subjects enrolled
    Sierra Leone: 55
    Worldwide total number of subjects
    108
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    108
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 142 subjects were screened in this study, out of which 108 subjects were enrolled in the main study (75 subjects in Ad26.ZEBOV + MVA-BN-Filo and 33 in MenACWY arms). Out of 105 subjects who completed the main study, 26 subjects were rolled over to an extension study, where 25 subjects completed the extension study.

    Period 1
    Period 1 title
    Main Study: Up to Day 365
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
    Arm description
    		 Healthy subjects (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of Ad26.ZEBOV (5*10^10 vp) vaccine was administered as an IM injection on Day 1.

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MenACWY vaccine was administered as an IM injection at 6-months post-dose-2 visit, that is Day 237.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MVA-BN-Filo (1*10^8 Inf U) vaccine was administered as an IM injection on Day 57.

    Arm title
    		 Main Study: MenACWY (Control Arm)
    Arm description
    		 Healthy subjects were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Subjects also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MenACWY vaccine was administered as an IM injection at 6-months post-dose-2 visit, that is Day 237.

    Number of subjects in period 1
    		Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Started
    75
    33
    Completed
    72
    33
    Not completed
    3
    0
         Unspecified
    1
    -
         Withdrawal by parent/guardian
    2
    -
    Period 2
    Period 2 title
    Extension Study: Up to Extension Day 85
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Extension Study: Ad26.ZEBOV + MVA-BN-Filo
    Arm description
    		 Subjects who were originally randomised to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects were also followed-up for safety until 28 days post-dose 2, that is, Day 85.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of MVA-BN-Filo (1*10^8 Inf U) vaccine was administered as an IM injection on Day 57.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of Ad26.ZEBOV (5*10^10 vp) vaccine was administered as an IM injection on Day 1.

    Number of subjects in period 2 [1]
    		Extension Study: Ad26.ZEBOV + MVA-BN-Filo
    Started
    26
    Completed
    25
    Not completed
    1
         Adverse event, non-fatal
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 105 subjects who completed the main study, only 26 subjects rolled-over to extension phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
    Reporting group description
    		 Healthy subjects (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.

    Reporting group title
    Main Study: MenACWY (Control Arm)
    Reporting group description
    		 Healthy subjects were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Subjects also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.

    Reporting group values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm) Total
    Number of subjects
    		 75 33 108
    Title for AgeCategorical
    Units: subjects
        4 to <= 8 months
    		 43 19 62
        >8 to 11 months
    		 32 14 46
    Title for AgeContinuous
    Units: months
        arithmetic mean (standard deviation)
    		 7.7 ( 2.51 ) 7.5 ( 2.66 ) -
    Title for Gender
    Units: subjects
        Female
    		 37 13 50
        Male
    		 38 20 58

    End points

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    End points reporting groups
    Reporting group title
    Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
    Reporting group description
    		 Healthy subjects (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.

    Reporting group title
    Main Study: MenACWY (Control Arm)
    Reporting group description
    		 Healthy subjects were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Subjects also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
    Reporting group title
    Extension Study: Ad26.ZEBOV + MVA-BN-Filo
    Reporting group description
    		 Subjects who were originally randomised to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects were also followed-up for safety until 28 days post-dose 2, that is, Day 85.

    Primary: Percentage of Subjects with Solicited Local and Systemic Adverse Events (AEs) at 7 Days Post-dose 1

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    End point title
    		 Percentage of Subjects with Solicited Local and Systemic Adverse Events (AEs) at 7 Days Post-dose 1 [1]
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which subject were specifically questioned and which were noted by subject in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. The full analysis set included all subjects with at least one study intervention administration documented.
    End point type
    Primary
    End point timeframe
    From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this study.
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    75
    33
    Units: Percentage of subjects
        number (not applicable)
    45.3
    30.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Solicited Local and Systemic AEs at 7 Days Post-dose 2

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    End point title
    		 Percentage of Subjects with Solicited Local and Systemic AEs at 7 Days Post-dose 2 [2]
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which subject were specifically questioned and which were noted by subject in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. The full analysis set included all subjects with at least one study intervention administration documented.
    End point type
    Primary
    End point timeframe
    From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this study.
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    75
    33
    Units: Percentage of Subjects
        number (not applicable)
    33.3
    36.4
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Unsolicited AEs at 28 Days Post-dose 1

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    End point title
    		 Percentage of Subjects with Unsolicited AEs at 28 Days Post-dose 1 [3]
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the subject voluntarily or obtained by means of interviewing the subject in a nondirected manner at study visits. The full analysis set included all subjects with at least one study intervention administration documented.
    End point type
    Primary
    End point timeframe
    From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this study.
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    75
    33
    Units: Percentage of Subjects
        number (not applicable)
    61.3
    66.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Unsolicited AEs at 28 Days Post-dose 2

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    End point title
    		 Percentage of Subjects with Unsolicited AEs at 28 Days Post-dose 2 [4]
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the subject voluntarily or obtained by means of interviewing the subject in a nondirected manner at study visits. The full analysis set included all subjects with at least one study intervention administration documented.
    End point type
    Primary
    End point timeframe
    From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this study.
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    75
    33
    Units: Percentage of Subjects
        number (not applicable)
    57.3
    72.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Subjects with Serious Adverse Events (SAEs) [5]
    End point description
    A SAE is an adverse event 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. The full analysis set included all subjects with at least one study intervention administration documented.
    End point type
    Primary
    End point timeframe
    Up to 6 months post dose-2 on Day 57 (Up to 8 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this study.
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    75
    33
    Units: Percentage of Subjects
        number (not applicable)
    13.3
    12.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects with SAEs Related to Study Intervention

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    End point title
    		 Percentage of Subjects with SAEs Related to Study Intervention [6]
    End point description
    Percentage of subjects with SAEs related to study intervention were reported. A SAE is an adverse event 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. The full analysis set included all subjects with at least one study intervention administration documented.
    End point type
    Primary
    End point timeframe
    Up to Day 365
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this study.
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    75
    33
    Units: Percentage of Subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP)

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    End point title
    		 Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP)
    End point description
    Geometric mean of binding antibody levels against the EBOV GP were reported. The per-protocol immunogenicity population included all randomised and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes (for example, missed Dose 2 vaccination, natural infections, etc.). Here, 99999 stands for data not available for geometric mean and confidence interval (CI) as the value was below lower limit of quantification (LLOQ) of 36.11 EU/mL.
    End point type
    Secondary
    End point timeframe
    21 days post-dose 2 (Day 78)
    End point values
    		 Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY Main Study: MenACWY (Control Arm)
    Number of subjects analysed
    74
    33
    Units: ELISA Units/millilitre (EU/mL)
        geometric mean (confidence interval 95%)
    24309 (19695 to 30005)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Main study: Up to Day 365 ; Extension study: Up to extension Day 85
    Adverse event reporting additional description
    The full analysis set included all subjects with at least one study intervention administration documented.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY
    Reporting group description
    		 Healthy subjects (infants) aged 4-11 months, were administered with 0.5 millilitre (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.

    Reporting group title
    Extension Study: Ad26.ZEBOV+MVA-BN-Filo
    Reporting group description
    		 Subjects who were originally randomised to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Subjects were also followed-up for safety until 28 days post-dose 2, that is, Day 85.

    Reporting group title
    Main Study: MenACWY (Control Arm)
    Reporting group description
    		 Healthy subjects were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Subjects also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.

    Serious adverse events
    		 Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY Extension Study: Ad26.ZEBOV+MVA-BN-Filo Main Study: MenACWY (Control Arm)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 75 (13.33%)
    0 / 26 (0.00%)
    4 / 33 (12.12%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypovolaemic Shock
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 75 (6.67%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Candidiasis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY Extension Study: Ad26.ZEBOV+MVA-BN-Filo Main Study: MenACWY (Control Arm)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 75 (77.33%)
    9 / 26 (34.62%)
    26 / 33 (78.79%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 26 (7.69%)
    0 / 33 (0.00%)
         occurrences all number
    2
    2
    0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 26 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis Allergic
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 26 (7.69%)
    0 / 33 (0.00%)
         occurrences all number
    1
    3
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 26 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    2
    Dermatitis Diaper
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    5
    0
    2
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    6 / 75 (8.00%)
    0 / 26 (0.00%)
    4 / 33 (12.12%)
         occurrences all number
    8
    0
    4
    Bronchitis
         subjects affected / exposed
    9 / 75 (12.00%)
    1 / 26 (3.85%)
    7 / 33 (21.21%)
         occurrences all number
    10
    1
    8
    Conjunctivitis Bacterial
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 26 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    3
    0
    2
    Gastrointestinal Candidiasis
         subjects affected / exposed
    5 / 75 (6.67%)
    0 / 26 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    5
    0
    1
    Gastroenteritis
         subjects affected / exposed
    6 / 75 (8.00%)
    0 / 26 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    6
    0
    2
    Furuncle
         subjects affected / exposed
    6 / 75 (8.00%)
    1 / 26 (3.85%)
    3 / 33 (9.09%)
         occurrences all number
    6
    1
    3
    Helminthic Infection
         subjects affected / exposed
    1 / 75 (1.33%)
    3 / 26 (11.54%)
    0 / 33 (0.00%)
         occurrences all number
    1
    3
    0
    Malaria
         subjects affected / exposed
    13 / 75 (17.33%)
    6 / 26 (23.08%)
    9 / 33 (27.27%)
         occurrences all number
    16
    10
    10
    Nasopharyngitis
         subjects affected / exposed
    12 / 75 (16.00%)
    0 / 26 (0.00%)
    6 / 33 (18.18%)
         occurrences all number
    13
    0
    10
    Oral Candidiasis
         subjects affected / exposed
    7 / 75 (9.33%)
    0 / 26 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    7
    0
    4
    Respiratory Tract Infection
         subjects affected / exposed
    15 / 75 (20.00%)
    1 / 26 (3.85%)
    9 / 33 (27.27%)
         occurrences all number
    19
    2
    12
    Rhinitis
         subjects affected / exposed
    10 / 75 (13.33%)
    0 / 26 (0.00%)
    5 / 33 (15.15%)
         occurrences all number
    12
    0
    5
    Upper Respiratory Tract Infection
         subjects affected / exposed
    8 / 75 (10.67%)
    3 / 26 (11.54%)
    6 / 33 (18.18%)
         occurrences all number
    8
    4
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Mar 2019
    The overall reason for the amendment was to allow flexibility in the amount of blood to be drawn for immunogenicity assessments and to clarify the intended study population age range.
    01 Oct 2019
    This amendment was written in response to the questions received from Food and Drug Administration (FDA) on 21-May-2019.
    06 Aug 2020
    The overall reason for the amendment was to ensure that final analysis Clinical Study Report (CSR) was completed within 6 months of study completion, in line with European Medicines Agency (EMA) Article 46.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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