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    Clinical Trial Results:
    A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

    Summary
    EudraCT number
    		 2015-004139-11
    Trial protocol
    		 GB   FR  
    Global end of trial date
    13 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC52150EBL4001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02661464
    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)
    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
    13 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to collect serious adverse event information from subjects exposed to Ad26 vector expressing the glycoprotein of the ebola virus mayinga variant (Ad26.ZEBOV) and/or modified vaccinia ankara bavarian nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2, or 3 clinical study, for a total of 60 months after prime vaccination (including the duration in the subject’s original study).
    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 Practice (GCP) and applicable regulatory requirements. Safety evaluations were based upon the serious adverse events reported throughout the study, and on incidence of pregnancy, incidence of pregnancy outcomes (including spontaneous/elective abortion, intrauterine death/stillbirth, information on delivery) and incidence of live-born children.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Burkina Faso: 79
    Country: Number of subjects enrolled
    France: 157
    Country: Number of subjects enrolled
    United Kingdom: 180
    Country: Number of subjects enrolled
    Kenya: 56
    Country: Number of subjects enrolled
    Tanzania, United Republic of: 16
    Country: Number of subjects enrolled
    Uganda: 28
    Country: Number of subjects enrolled
    United States: 154
    Worldwide total number of subjects
    670
    EEA total number of subjects
    157
    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)
    3
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    664
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No pregnant female from Cohort 1 who became pregnant in a Phase 1, 2 or 3 study were enrolled in Cohort 2. Hence Cohort 2 and its related endpoints not reported as planned. Out of 3 pregnant females, 2 did not enroll in current study. 1 completed Phase 1, 2 or 3 study and enrolled in Cohort 1 as she was not pregnant when enrolled in current study.

    Pre-assignment
    Screening details
    		 A total of 677 subjects who received Ad26.ZEBOV and/or MVA-BN-Filo or Placebo in a Phase 1, 2 or 3 study were enrolled. Seven subjects were excluded from further analysis as they had no post baseline visits in current study. Therefore, 670 subjects were analysed out which 296 subjects completed the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo
    Arm description
    		 Safety data of subjects vaccinated with Ad26 vector expressing the glycoprotein of the Ebola virus mayinga variant (Ad26.ZEBOV) and/or modified vaccinia ankara bavarian nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.
    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
    Subjects received intramuscular injection of MVA-BN-Filo at specified time points in a Phase 1, 2 or 3 study.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received intramuscular injection of Ad26.ZEBOV at specified time points in a Phase 1, 2 or 3 study.

    Arm title
    		 Cohort 1: Placebo
    Arm description
    		 Safety data of subjects vaccinated with Ad26.ZEBOV matching placebo and/or MVA-BN-Filo matching placebo in) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received intramuscular injection of Ad26.ZEBOV or MVA-BN-Filo matching placebo at specified time points in a Phase 1, 2 or 3 study.

    Arm title
    		 Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo
    Arm description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV and/or MVA-BNFilo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.
    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
    Children born to females who received intramuscular injection of MVA-BN-Filo matching placebo at specified time points in a Phase 1, 2 or 3 study.

    Investigational medicinal product name
    Ad26.ZEBOV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children born to females who received intramuscular injection of Ad26.ZEBOV at specified time points in a Phase 1, 2 or 3 study.

    Arm title
    		 Cohort 3: Placebo
    Arm description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV matching placebo and/or MVA-BNFilo matching placebo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo matching placebo or within 3 months after vaccination with Ad26.ZEBOV matching placebo and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children born to females who received intramuscular injection of Ad26.ZEBOV or MVA-BN-Filo matching placebo at specified time points in a Phase 1, 2 or 3 study.

    Number of subjects in period 1
    		Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 1: Placebo Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 3: Placebo
    Started
    614
    53
    2
    1
    Completed
    295
    0
    1
    0
    Not completed
    319
    53
    1
    1
         Study terminated by sponsor
    -
    -
    1
    -
         Unspecified
    288
    52
    -
    1
         Lost to follow-up
    28
    -
    -
    -
         Withdrawal by subject
    3
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo
    Reporting group description
    		 Safety data of subjects vaccinated with Ad26 vector expressing the glycoprotein of the Ebola virus mayinga variant (Ad26.ZEBOV) and/or modified vaccinia ankara bavarian nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Safety data of subjects vaccinated with Ad26.ZEBOV matching placebo and/or MVA-BN-Filo matching placebo in) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo
    Reporting group description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV and/or MVA-BNFilo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV matching placebo and/or MVA-BNFilo matching placebo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo matching placebo or within 3 months after vaccination with Ad26.ZEBOV matching placebo and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.

    Reporting group values
    		 Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 1: Placebo Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 3: Placebo Total
    Number of subjects
    		 614 53 2 1 670
    Title for AgeCategorical
    Units: subjects
    Title for AgeContinuous
    In "Cohort 3: Placebo" arm, 99999 signifies standard deviation could not be estimated as only one subject contributed to the data.
    Units: years
        arithmetic mean (standard deviation)
    		 35.6 ( 13 ) 37 ( 13.44 ) 1.2 ( 0.41 ) 1.3 ( 99999 ) -
    Title for Gender
    Units: subjects
        Female
    		 254 24 1 0 279
        Male
    		 360 29 1 1 391

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo
    Reporting group description
    		 Safety data of subjects vaccinated with Ad26 vector expressing the glycoprotein of the Ebola virus mayinga variant (Ad26.ZEBOV) and/or modified vaccinia ankara bavarian nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Safety data of subjects vaccinated with Ad26.ZEBOV matching placebo and/or MVA-BN-Filo matching placebo in) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo
    Reporting group description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV and/or MVA-BNFilo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV matching placebo and/or MVA-BNFilo matching placebo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo matching placebo or within 3 months after vaccination with Ad26.ZEBOV matching placebo and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.

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

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    End point title
    		 Percentage of Subjects With Serious Adverse Events (SAEs) [1]
    End point description
    A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important. Full Analysis Set (FAS) included all subjects who were enrolled in this study and had at least one post baseline visit, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to 60 months after dose 1 vaccination (including the duration in the Subjects original study)
    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 was done, no inferential statistical analysis was performed.
    End point values
    		 Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 1: Placebo Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 3: Placebo
    Number of subjects analysed
    614
    53
    2
    1
    Units: Percentage of subjects
        number (not applicable)
    49
    1
    2
    1
    No statistical analyses for this end point

    Primary: Number of Live-Born Children From a Pregnancy With Estimated Conception Within 28 Days After Vaccination With MVA-BN-Filo or Within 3 Months After Vaccination With Ad26.ZEBOV

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    End point title
    		 Number of Live-Born Children From a Pregnancy With Estimated Conception Within 28 Days After Vaccination With MVA-BN-Filo or Within 3 Months After Vaccination With Ad26.ZEBOV [2] [3]
    End point description
    Number of live-born children from a pregnancy with estimated conception within 28 days after vaccination with modified vaccinia ankara bavarian nordic vector expressing multiple filovirus proteins (MVA-BN-Filo) or within 3 months after vaccination with Ad26 vector expressing the glycoprotein of the Ebola virus mayinga variant (Ad26.ZEBOV) were reported. Data of this endpoint is reported only for Cohort 3 because only Cohort 3 subjects were children. FAS included all subjects who were enrolled in this study and had at least one post baseline visit, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV
    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 was done, no inferential statistical analysis was performed.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 3: Placebo
    Number of subjects analysed
    2
    1
    Units: Children
    2
    1
    No statistical analyses for this end point

    Primary: Number of Children With Serious Adverse Events who Were Born From a Pregnancy With Estimated Conception Within 28 Days After Vaccination With MVA-BN-Filo or Within 3 Months After Vaccination With Ad26.ZEBOV up to 60 Months After Birth

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    End point title
    		 Number of Children With Serious Adverse Events who Were Born From a Pregnancy With Estimated Conception Within 28 Days After Vaccination With MVA-BN-Filo or Within 3 Months After Vaccination With Ad26.ZEBOV up to 60 Months After Birth [4] [5]
    End point description
    A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important. Data for this endpoint was reported only for Cohort 3 because only Cohort 3 had children. FAS included all subjects who were enrolled in this study and had at least one post baseline visit, regardless of the occurrence of protocol deviations.
    End point type
    Primary
    End point timeframe
    Up to 60 months after birth
    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 was done, no inferential statistical analysis was performed.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Cohort 3: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 3: Placebo
    Number of subjects analysed
    2
    1
    Units: Children
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 60 months after dose 1 vaccination (including the duration in the subjects original study)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo
    Reporting group description
    		 Safety data of subjects vaccinated Ad26.ZEBOV and/or MVA-BN-Filo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Safety data of subjects vaccinated with Ad26.ZEBOV matching placebo and/or MVA-BN-Filo matching placebo in) in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003 (adults, adolescents and children) and who consented to participate in the current study was collected in 6-month intervals and up to a total of 60 months after vaccination (including the duration in the subject’s original study). No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 3: Ad26.ZEBOV and/or MVA-BNFilo
    Reporting group description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV and/or MVA-BNFilo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Safety data of children born to female subjects exposed to Ad26.ZEBOV matching placebo and/or MVA-BNFilo matching placebo in Phase 1, 2 or 3 clinical studies VAC52150EBL1001, VAC52150EBL1002, VAC52150EBL1003, VAC52150EBL1004, VAC52150EBL2001, VAC52150EBL2002, VAC52150EBL3002 and VAC52150EBL3003, who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo matching placebo or within 3 months after vaccination with Ad26.ZEBOV matching placebo and for whom consent for the current study was given, was collected in 6-month intervals and up to 60 months after birth. No vaccine was to be administered in the current study.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only serious adverse events were planned to be collected and investigated during the study. Non-Serious adverse events were not collected, and therefore not tabulated.
    Serious adverse events
    		 Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 1: Placebo Cohort 3: Ad26.ZEBOV and/or MVA-BNFilo Cohort 3: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    49 / 614 (7.98%)
    1 / 53 (1.89%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid Tumour Benign
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Appendicectomy
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Caesarean Section
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    2 / 614 (0.33%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anembryonic Gestation
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Medical Device Discomfort
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food Allergy
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural Haematoma
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid Artery Dissection
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Venous Thrombosis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial Syndrome
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial Paralysis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningism
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Miller Fisher Syndrome
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Fibre Neuropathy
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    3 / 614 (0.49%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    2 / 614 (0.33%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess Limb
         subjects affected / exposed
    0 / 614 (0.00%)
    1 / 53 (1.89%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    3 / 614 (0.49%)
    0 / 53 (0.00%)
    2 / 2 (100.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    0 / 614 (0.00%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid Fever
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 614 (0.16%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 1: Ad26.ZEBOV and/or MVA-BN-Filo Cohort 1: Placebo Cohort 3: Ad26.ZEBOV and/or MVA-BNFilo Cohort 3: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 614 (0.00%)
    0 / 53 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2016
    Originally, all subjects who were exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 clinical study were to be approached to consent for enrollment into the VAC52150EBL4001 study. With this amendment, this was no longer be the case. Each local authority will determine which cohorts will be opened for enrollment in their region. It is not mandatory to open all cohorts for enrollment. As a result, a local authority may restrict enrollment to 1 or 2 cohorts, rather than allowing enrollment in all cohorts. The original development plan (at the time of the ongoing Ebola epidemic in Africa) was an accelerated plan with the anticipation of conducting Phase 3 efficacy studies (with limited safety data collection) shortly after Phase 1 and in parallel with Phase 2. The sponsor designed the VAC52150EBL4001 study for the extended follow-up of serious adverse events (SAEs) to enhance the ability for signal detection of rare events. Since there is no longer an ongoing Ebola epidemic, it is not currently possible to conduct a parallel Phase 3 efficacy study as part of an accelerated development plan. More controlled safety data will become available for all vaccinated subjects, therefore, prior to any potential future efficacy study.
    30 Sep 2016
    Since validated assays were not available to assess immune responses in the ongoing Phase 2 and 3 studies, unblinding of these studies had been delayed. Therefore, subjects who received placebo in their original Phase 2 or 3 study were also approached for enrollment into the VAC52150 Vaccine Development Roll-over study before unblinding of their original study.

    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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