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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2019-000691-42
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    03 Jul 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Jan 2020
    First version publication date
    11 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC52150EBL3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02509494
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Archimedesweg 4-6, Leiden, Netherlands, 2333 CN
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002573-PIP01-19
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study during stage 1 was to evaluate the safety of a 2-dose heterologous vaccination regimen utilizing adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as dose 1 and Modified Vaccinia Ankara - Bavarian Nordic-multivalent filovirus vector (MVA-BN-Filo) as dose 2, administered at a 56-day interval and during stage 2 was to evaluate the safety of a 2-dose heterologous vaccination regimen utilizing Ad26.ZEBOV as dose 1 and MVA-BN-Filo as dose 2, administered at a 56-day interval, compared to an active control vaccine.
    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 and applicable regulatory requirements. Safety evaluations included measurement of vital signs, clinical laboratory tests (Hematology, serum chemistry and urinalysis), physical examinations, assessment of adverse events (AEs).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Sep 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    36 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sierra Leone: 1020
    Worldwide total number of subjects
    1020
    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)
    70
    Children (2-11 years)
    314
    Adolescents (12-17 years)
    192
    Adults (18-64 years)
    440
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1020 subjects were enrolled in the study. Of the 1020 subjects, 443 (adult) subjects were enrolled in Stages 1 and 2 and 577 (adolescents and children) subjects in Stage 2.

    Period 1
    Period 1 title
    REGIMEN (overall period)
    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
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV
    Arm description
    Subjects received 0.5 milliliter (mL) of adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) (5*10^10 viral particles [vp]) intramuscular (IM) injection as Dose 1 on Day 1 followed by 0.5 mL of Modified Vaccinia Ankara - Bavarian Nordic-multivalent filovirus vector (MVA-BN-Filo) (1*10^8 infectious units [Inf.U]) IM injection as Dose 2 on Day 57. The booster vaccination of 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection was administered to subjects who consented (2 years [Day 720] post Dose 1).
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection.

    Arm title
    Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo
    Arm description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection.

    Arm title
    Stage 2, Adults: MenACWY, Placebo
    Arm description
    Subjects received 0.5 mL of Meningococcal Group A, C, W135 and Y conjugate vaccine (MenACWY) vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received matching placebo (0.9 percent [%] saline) as IM injection.

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL IM injection of MenACWY vaccine as Dose 1.

    Arm title
    Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo
    Arm description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection.

    Arm title
    Stage 2, 12-17 Years: MenACWY, Placebo
    Arm description
    Subjects received 0.5 mL of MenACWY vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL IM injection of MenACWY vaccine as Dose 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received matching placebo (0.9% saline) as IM injection.

    Arm title
    Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo
    Arm description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection.

    Arm title
    Stage 2, 4-11 Years: MenACWY, Placebo
    Arm description
    Subjects received 0.5 mL of MenACWY vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL IM injection of MenACWY vaccine as Dose 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received matching placebo (0.9% saline) as IM injection.

    Arm title
    Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo
    Arm description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received placebo at 3 months post dose 2.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received matching placebo (0.9% saline) as IM injection.

    Investigational medicinal product name
    MVA-BN-Filo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection.

    Arm title
    Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Arm description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received MenACWY at 3 months post dose 2.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received matching placebo (0.9% saline) as IM injection.

    Investigational medicinal product name
    MenACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL IM injection of MenACWY vaccine as Dose 1.

    Number of subjects in period 1 [1]
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Started
    43
    298
    102
    143
    48
    144
    48
    144
    48
    Completed
    28
    217
    64
    132
    43
    133
    45
    137
    46
    Not completed
    15
    81
    38
    11
    5
    11
    3
    7
    2
         Physician decision
    2
    1
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    4
    17
    7
    5
    -
    6
    1
    2
    1
         Death
    -
    1
    -
    -
    1
    -
    -
    1
    -
         Non-compliance with study drug
    1
    11
    7
    -
    1
    2
    1
    1
    -
         Unspecified
    -
    4
    5
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    8
    47
    19
    6
    3
    3
    1
    3
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Two participants were excluded from the summary tables because one received Ad26.ZEBOV followed by placebo and the other received MVA-BN-Filo as dose 1 (i.e. both sequences not in accordance with the protocol).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV
    Reporting group description
    Subjects received 0.5 milliliter (mL) of adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) (5*10^10 viral particles [vp]) intramuscular (IM) injection as Dose 1 on Day 1 followed by 0.5 mL of Modified Vaccinia Ankara - Bavarian Nordic-multivalent filovirus vector (MVA-BN-Filo) (1*10^8 infectious units [Inf.U]) IM injection as Dose 2 on Day 57. The booster vaccination of 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection was administered to subjects who consented (2 years [Day 720] post Dose 1).

    Reporting group title
    Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, Adults: MenACWY, Placebo
    Reporting group description
    Subjects received 0.5 mL of Meningococcal Group A, C, W135 and Y conjugate vaccine (MenACWY) vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 12-17 Years: MenACWY, Placebo
    Reporting group description
    Subjects received 0.5 mL of MenACWY vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 4-11 Years: MenACWY, Placebo
    Reporting group description
    Subjects received 0.5 mL of MenACWY vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received placebo at 3 months post dose 2.

    Reporting group title
    Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Reporting group description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received MenACWY at 3 months post dose 2.

    Reporting group values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY Total
    Number of subjects
    43 298 102 143 48 144 48 144 48 1018
    Title for AgeCategorical
    Units: subjects
        Children (1-3 years)
    0 0 0 0 0 0 0 144 48 192
        Adolescents (12-17 years)
    0 0 0 143 48 0 0 0 0 191
        Adults (18-64 years)
    43 295 101 0 0 0 0 0 0 439
        From 65 to 84 years
    0 3 1 0 0 0 0 0 0 4
        85 years and over
    0 0 0 0 0 0 0 0 0 0
        Children (4-11 years)
    0 0 0 0 0 144 48 0 0 192
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    26.9 ± 9.87 27.5 ± 10.46 29.6 ± 11.6 14.2 ± 1.58 14 ± 1.58 7.7 ± 1.88 7.9 ± 1.96 1.9 ± 0.79 1.9 ± 0.76 -
    Title for Gender
    Units: subjects
        Female
    1 50 22 69 21 73 26 67 21 350
        Male
    42 248 80 74 27 71 22 77 27 668

    End points

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    End points reporting groups
    Reporting group title
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV
    Reporting group description
    Subjects received 0.5 milliliter (mL) of adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) (5*10^10 viral particles [vp]) intramuscular (IM) injection as Dose 1 on Day 1 followed by 0.5 mL of Modified Vaccinia Ankara - Bavarian Nordic-multivalent filovirus vector (MVA-BN-Filo) (1*10^8 infectious units [Inf.U]) IM injection as Dose 2 on Day 57. The booster vaccination of 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection was administered to subjects who consented (2 years [Day 720] post Dose 1).

    Reporting group title
    Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, Adults: MenACWY, Placebo
    Reporting group description
    Subjects received 0.5 mL of Meningococcal Group A, C, W135 and Y conjugate vaccine (MenACWY) vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 12-17 Years: MenACWY, Placebo
    Reporting group description
    Subjects received 0.5 mL of MenACWY vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 4-11 Years: MenACWY, Placebo
    Reporting group description
    Subjects received 0.5 mL of MenACWY vaccine as Dose 1 on Day 1 and then matching placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received placebo at 3 months post dose 2.

    Reporting group title
    Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Reporting group description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received MenACWY at 3 months post dose 2.

    Primary: Stages 1 and 2: Percentage of Subjects with Solicited Local Adverse Events

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    End point title
    Stages 1 and 2: Percentage of Subjects with Solicited Local Adverse Events [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. Subjects with solicited local (injection site) adverse events were instructed on how to note occurrences of erythema, induration/swelling (measured using the ruler supplied), pain/tenderness and itching at the injection site in the evening after each study vaccine administration and then daily for the next 7 days in the diary. Full Analysis set included all subjects who received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' indicates the number of subjects who were analyzed at specified timepoint for each arm and '99999' defines that Dose 3 was not administered in Stage 2 participants hence no data with solicited local AEs is available.
    End point type
    Primary
    End point timeframe
    Until 7 days post each dose (Day 727 for Stage 1 and Day 64 for Stage 2)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Number of subjects analysed
    43
    298
    102
    143
    48
    144
    48
    144
    48
    Units: Percentage of subjects
    number (not applicable)
        Post-dose 1 (n=43,298,102,143,48,144,48,144,48)
    27.9
    17.1
    16.7
    9.8
    6.3
    20.8
    4.2
    14.6
    10.4
        Post-dose 2 (n=43,246,86,142,46,143,48,143,48)
    14.0
    23.6
    9.3
    14.8
    2.2
    15.4
    10.4
    4.9
    0
        Post-dose 3 (n=29,0,0,0,0,0,0,0,0)
    17.2
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Primary: Stages 1 and 2: Percentage of Subjects with Solicited Systemic Adverse Events

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    End point title
    Stages 1 and 2: Percentage of Subjects with Solicited Systemic Adverse Events [2]
    End point description
    An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. Solicited systemic AEs included fever (defined as body temperature of 38 degree Celsius or higher), Headache, fatigue/Malaise, myalgia, nausea/vomiting, arthralgia, chills, decreased activity, decreased appetite, and irritability. Full Analysis set included all subjects who received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' indicates the number of subjects who were analyzed at specified timepoint for each arm and '99999' defines that dose 3 was not administered in Stage 2 participants hence no data with systemic AEs is available.
    End point type
    Primary
    End point timeframe
    Until 7 days post each dose (Day 727 for Stage 1 and Day 64 for Stage 2)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Number of subjects analysed
    43
    298
    102
    143
    48
    144
    48
    144
    48
    Units: Percentage of subjects
    number (not applicable)
        Post-dose 1 (n=43,298,102,143,48,144,48,144,48)
    41.9
    54.0
    50.0
    36.4
    29.2
    31.3
    31.3
    25.0
    25.0
        Post-dose 2 (n=43,246,86,142,46,143,48143,48)
    39.5
    43.5
    45.3
    18.3
    13.0
    18.9
    16.7
    16.1
    29.2
        Post-dose 3 (n=29,0,0,0,0,0,0,0,0)
    31.0
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Primary: Stages 1 and 2: Percentage of Subjects with Unsolicited Adverse Events

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    End point title
    Stages 1 and 2: Percentage of Subjects with Unsolicited Adverse Events [3]
    End point description
    An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. Unsolicited adverse events were all adverse events for which the participant was specifically not questioned in the participant diary. Full Analysis set included all subjects who received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' indicates the number of subjects who were analyzed at specified timepoint for each arm and '99999' defines that Dose 3 was not administered in Stage 2 participants hence no data with unsolicited AEs is available.
    End point type
    Primary
    End point timeframe
    Up to Day 748 (Stage 1) and Up to Day 85 (Stage 2)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Number of subjects analysed
    43
    298
    102
    143
    48
    144
    48
    144
    48
    Units: Percentage of subjects
    number (not applicable)
        Post-dose 1 (n=43,298,102,143,48,144,48,144,48)
    39.5
    66.4
    63.7
    37.8
    41.7
    41.7
    37.5
    61.1
    58.3
        Post-dose 2 (n=43,246,86,142,46,143,48,143,48)
    39.5
    58.9
    55.8
    34.5
    28.3
    32.2
    27.1
    53.8
    60.4
        Post-dose 3 (n=29,0,0,0,0,0,0,0,0)
    17.2
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Primary: Stages 1 and 2: Percentage of Subjects with Serious Adverse Events (SAEs)

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    End point title
    Stages 1 and 2: Percentage of Subjects with Serious Adverse Events (SAEs) [4]
    End point description
    SAEs are any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), 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 included all subjects who received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' indicates the number of subjects who were analyzed at specified timepoint for each arm and '99999' defines that Dose 3 was not administered in Stage 2 participants hence no data for SAEs is available.
    End point type
    Primary
    End point timeframe
    Until end of study (Up to 38 months)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Number of subjects analysed
    43
    298
    102
    143
    48
    144
    48
    144
    48
    Units: Percentage of subjects
        number (not applicable)
    43
    298
    102
    143
    48
    144
    48
    144
    48
    No statistical analyses for this end point

    Primary: Stages 1 and 2: Percentage of Subjects with Immediate Reportable Events (IREs)

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    End point title
    Stages 1 and 2: Percentage of Subjects with Immediate Reportable Events (IREs) [5]
    End point description
    Any event of neuroimmunologic significance categorized as IREs which includes Cranial nerve disorders, Optic neuritis, Multiple sclerosis, Transverse myelitis, Guillain-Barre syndrome (Miller Fisher syndrome, Bickerstaff’s encephalitis), Acute disseminated encephalomyelitis (including site specific variants: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), Myasthenia gravis and Lambert-Eaton myasthenic syndrome, Immune-mediated peripheral neuropathies and plexopathies (chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonal gammopathy), Narcolepsy, Isolated paresthesia of more than 7 days duration. Full Analysis set included all subjects who received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Until end of study (up to 38 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Number of subjects analysed
    43
    298
    102
    143
    48
    144
    48
    144
    48
    Units: Percentage of subjects
    number (not applicable)
        Post-dose 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Post-dose 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Post-dose 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Stages 1 and 2: Percentage of Subjects with Anti-Ebola Virus (EBOV) Glycoprotein (GP) Binding Antibody Response Rate

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    End point title
    Stages 1 and 2: Percentage of Subjects with Anti-Ebola Virus (EBOV) Glycoprotein (GP) Binding Antibody Response Rate
    End point description
    Vaccine-induced binding antibody responses were measured using an EBOV GP Filovirus Animal Nonclinical Group (FANG) enzyme-linked immunosorbent assay (ELISA). The per Protocol analysis set included all randomized and vaccinated subjects, who received both the dose 1 and dose 2 (administered not more than 10 days outside the visit window) vaccinations, had immunogenicity data from baseline and at least one post-vaccination evaluable immunogenicity sample, and had no major protocol violations influencing the immune response. For the participants in Stage 1 who received the booster dose: including all participants who received dose 1, dose 2, and the booster dose (within the protocol-defined window), had at least one post-vaccination (after the date of vaccination) evaluable immunogenicity sample, and had no major protocol deviations influencing the immune response. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Stages 1 and 2: Day 78 (21 days post Dose 2)
    End point values
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Number of subjects analysed
    42
    182
    62
    134
    46
    124
    42
    123
    38
    Units: Percentage of subjects
        number (not applicable)
    97.6
    98.3
    3.3
    97.8
    2.2
    99.2
    7.1
    97.5
    2.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until end of study (up to 38 months)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV
    Reporting group description
    Subjects received 0.5 milliliter (mL) of Ad26.ZEBOV (5*10^10 viral particles [vp]) intramuscular (IM) injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 infectious units [Inf.U]) IM injection as Dose 2 on Day 57. The booster vaccination of 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection was administered to subjects who consented (2 years [Day 720] post Dose 1).

    Reporting group title
    Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, Adults: MenACWY, Placebo
    Reporting group description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 12-17 Years: MenACWY, Placebo
    Reporting group description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 4-11 Years: MenACWY, Placebo
    Reporting group description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57.

    Reporting group title
    Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo
    Reporting group description
    Subjects received 0.5 mL of Ad26.ZEBOV (5*10^10 vp) IM injection as Dose 1 on Day 1 followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf.U) IM injection as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received placebo at 3 months post dose 2.

    Reporting group title
    Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Reporting group description
    Subjects received MenACWY vaccine as Dose 1 on Day 1 and then placebo as Dose 2 on Day 57. Children aged less than (<) 2 years at randomization received MenACWY at 3 months post dose 2.

    Serious adverse events
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 43 (6.98%)
    16 / 298 (5.37%)
    4 / 102 (3.92%)
    0 / 143 (0.00%)
    1 / 48 (2.08%)
    5 / 144 (3.47%)
    0 / 48 (0.00%)
    15 / 144 (10.42%)
    3 / 48 (6.25%)
         number of deaths (all causes)
    0
    1
    0
    0
    1
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Abortion Induced Incomplete
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 298 (0.67%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open Globe Injury
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin Laceration
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic Shock
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile Convulsion
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    1 / 102 (0.98%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Threatened
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage in Pregnancy
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placenta Praevia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature Labour
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    4 / 144 (2.78%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Anaemia of Pregnancy
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal Detachment
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Haematoma
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    1 / 102 (0.98%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 298 (0.67%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain Abscess
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chorioretinitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 298 (0.67%)
    3 / 102 (2.94%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Helminthic Infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 298 (1.01%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    2 / 144 (1.39%)
    0 / 48 (0.00%)
    14 / 144 (9.72%)
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 14
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Meningitis Bacterial
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    4 / 144 (2.78%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    6 / 144 (4.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid Fever
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    1 / 48 (2.08%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 298 (0.34%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Stage 1, Adults: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV Stage 2, Adults: Ad26.ZEBOV, MVA-BN-Filo Stage 2, Adults: MenACWY, Placebo Stage 2, 12-17 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 12-17 Years: MenACWY, Placebo Stage 2, 4-11 Years: Ad26.ZEBOV, MVA-BN-Filo Stage 2, 4-11 Years: MenACWY, Placebo Stage 2, 1-3 Years: Ad26.ZEBOV, MVA-BN-Filo, Placebo Stage 2, 1-3 Years: MenACWY, Placebo, MenACWY
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 43 (51.16%)
    194 / 298 (65.10%)
    63 / 102 (61.76%)
    56 / 143 (39.16%)
    18 / 48 (37.50%)
    69 / 144 (47.92%)
    21 / 48 (43.75%)
    108 / 144 (75.00%)
    38 / 48 (79.17%)
    Investigations
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 43 (0.00%)
    7 / 298 (2.35%)
    2 / 102 (1.96%)
    8 / 143 (5.59%)
    5 / 48 (10.42%)
    3 / 144 (2.08%)
    1 / 48 (2.08%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    11
    2
    9
    7
    3
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 43 (20.93%)
    40 / 298 (13.42%)
    13 / 102 (12.75%)
    14 / 143 (9.79%)
    2 / 48 (4.17%)
    4 / 144 (2.78%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    10
    42
    13
    14
    2
    4
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 298 (0.67%)
    0 / 102 (0.00%)
    1 / 143 (0.70%)
    3 / 48 (6.25%)
    6 / 144 (4.17%)
    4 / 48 (8.33%)
    13 / 144 (9.03%)
    1 / 48 (2.08%)
         occurrences all number
    1
    2
    0
    1
    3
    6
    4
    16
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    3 / 43 (6.98%)
    16 / 298 (5.37%)
    10 / 102 (9.80%)
    3 / 143 (2.10%)
    1 / 48 (2.08%)
    0 / 144 (0.00%)
    1 / 48 (2.08%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    3
    17
    10
    3
    1
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 298 (0.67%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    8 / 144 (5.56%)
    3 / 48 (6.25%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    9
    5
    Peptic Ulcer
         subjects affected / exposed
    0 / 43 (0.00%)
    15 / 298 (5.03%)
    1 / 102 (0.98%)
    0 / 143 (0.00%)
    1 / 48 (2.08%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    16
    1
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus Generalised
         subjects affected / exposed
    1 / 43 (2.33%)
    15 / 298 (5.03%)
    5 / 102 (4.90%)
    3 / 143 (2.10%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
         occurrences all number
    1
    16
    5
    3
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 43 (4.65%)
    16 / 298 (5.37%)
    7 / 102 (6.86%)
    1 / 143 (0.70%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    16
    7
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Furuncle
         subjects affected / exposed
    6 / 43 (13.95%)
    11 / 298 (3.69%)
    3 / 102 (2.94%)
    2 / 143 (1.40%)
    1 / 48 (2.08%)
    1 / 144 (0.69%)
    2 / 48 (4.17%)
    6 / 144 (4.17%)
    3 / 48 (6.25%)
         occurrences all number
    6
    11
    3
    2
    3
    1
    2
    6
    3
    Gastroenteritis
         subjects affected / exposed
    1 / 43 (2.33%)
    10 / 298 (3.36%)
    2 / 102 (1.96%)
    1 / 143 (0.70%)
    0 / 48 (0.00%)
    3 / 144 (2.08%)
    2 / 48 (4.17%)
    7 / 144 (4.86%)
    5 / 48 (10.42%)
         occurrences all number
    1
    11
    3
    1
    0
    3
    2
    8
    5
    Malaria
         subjects affected / exposed
    6 / 43 (13.95%)
    123 / 298 (41.28%)
    40 / 102 (39.22%)
    35 / 143 (24.48%)
    9 / 48 (18.75%)
    50 / 144 (34.72%)
    14 / 48 (29.17%)
    81 / 144 (56.25%)
    26 / 48 (54.17%)
         occurrences all number
    6
    150
    50
    40
    11
    56
    18
    116
    39
    Nasopharyngitis
         subjects affected / exposed
    0 / 43 (0.00%)
    21 / 298 (7.05%)
    5 / 102 (4.90%)
    1 / 143 (0.70%)
    0 / 48 (0.00%)
    5 / 144 (3.47%)
    0 / 48 (0.00%)
    6 / 144 (4.17%)
    5 / 48 (10.42%)
         occurrences all number
    0
    23
    5
    1
    0
    5
    0
    6
    5
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 43 (4.65%)
    15 / 298 (5.03%)
    4 / 102 (3.92%)
    6 / 143 (4.20%)
    2 / 48 (4.17%)
    4 / 144 (2.78%)
    4 / 48 (8.33%)
    17 / 144 (11.81%)
    5 / 48 (10.42%)
         occurrences all number
    2
    17
    4
    8
    2
    4
    4
    19
    5
    Tinea Capitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 298 (0.00%)
    0 / 102 (0.00%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    2 / 144 (1.39%)
    1 / 48 (2.08%)
    2 / 144 (1.39%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    3
    3
    Typhoid Fever
         subjects affected / exposed
    1 / 43 (2.33%)
    14 / 298 (4.70%)
    9 / 102 (8.82%)
    0 / 143 (0.00%)
    0 / 48 (0.00%)
    1 / 144 (0.69%)
    0 / 48 (0.00%)
    0 / 144 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    14
    9
    0
    0
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 43 (2.33%)
    16 / 298 (5.37%)
    8 / 102 (7.84%)
    3 / 143 (2.10%)
    1 / 48 (2.08%)
    9 / 144 (6.25%)
    4 / 48 (8.33%)
    26 / 144 (18.06%)
    9 / 48 (18.75%)
         occurrences all number
    1
    18
    8
    3
    1
    9
    4
    32
    11

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 May 2015
    The first amendment was written in response to the Assisted Review of the Janssen Ebola Zaire Vaccine Clinical Trials Application meeting in April 2015.
    30 Nov 2015
    With the declaration of Sierra Leone as Ebola-free on 07 November 2015, and in line with feedback from the Food and Drug Administration (FDA) and European Medicines Agency (EMA), a control arm was added to Stage 2, which would now become an individually randomized, double-blinded, active-controlled study.
    28 Jan 2016
    The main objective of an originally planned Stage 3 of the study was to assess vaccine effectiveness in preventing cases of ebola virus disease (EVD).
    07 Sep 2016
    The sponsor halted vaccinations in the clinical program after receipt of a serious case of Miller Fisher syndrome post MVA-BN-Filo vaccination in Phase 2 study VAC52150EBL2001, as well as reports of mild transient paresthesia in the same study that required further assessment to rule out a neurologic and autoimmune event. Stage 1 was extended for 24 months beyond Day 360 post dose 1 for long-term follow-up of safety and immunogenicity.
    04 May 2017
    This amendment was developed in response to emerging clinical data and changes to the global clinical development plan.
    20 Jun 2018
    This amendment was made to replace information on VAC52150 Vaccine Development Rollover study VAC52150EBL4001 with information on long-term follow-up study VAC52150EBL3005.
    02 Oct 2018
    This amendment was made to clarify that for each age group of Stage 2, participants and studysite personnel were blinded to study vaccine allocation until the last participant in that age group completed at least the 6-month post-dose 2 visit or discontinued earlier and the database had been locked for that part.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Apr 2016
    The site was notified to halt all vaccinations due to the occurrence of Miller Fisher syndrome in a study participant in the Phase 2 study VAC52150EBL2001.
    25 Jul 2016

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In Stage 2, 140 adult participants either did not receive the dose 2 vaccination (N=68) or received it later than planned (that is, outside of the protocol-defined interval), mainly due to the study pause (N=72).
    For support, Contact us.
    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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