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    Clinical Trial Results:
    Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3- Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age

    Summary
    EudraCT number
    		 2017-004233-86
    Trial protocol
    		 FI   ES  
    Global end of trial date
    30 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Nov 2021
    First version publication date
    17 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V160-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03486834
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 58
    Country: Number of subjects enrolled
    Canada: 316
    Country: Number of subjects enrolled
    Spain: 164
    Country: Number of subjects enrolled
    Finland: 400
    Country: Number of subjects enrolled
    Israel: 260
    Country: Number of subjects enrolled
    Russian Federation: 75
    Country: Number of subjects enrolled
    United States: 927
    Worldwide total number of subjects
    2200
    EEA total number of subjects
    564
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    53
    Adults (18-64 years)
    2147
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of approximately 2100 participants were planned to be enrolled with 2200 participants actually randomized.

    Period 1
    Period 1 title
    Overall Study (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
    		 V160 3-Dose Regimen
    Arm description
    		 Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V160
    Investigational medicinal product code
    Other name
    Human cytomegalovirus vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.

    Arm title
    		 V160 2-Dose Regimen
    Arm description
    		 Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V160
    Investigational medicinal product code
    Other name
    Human cytomegalovirus vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
    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
    Saline solution administered as a 0.5 mL IM injection

    Number of subjects in period 1
    		V160 3-Dose Regimen V160 2-Dose Regimen Placebo
    Started
    733
    733
    734
    Treatment 1
    729
    729
    733
    Treatment 2
    680
    680
    679
    Treatment 3
    614
    631
    622
    Completed
    614
    631
    622
    Not completed
    119
    102
    112
         Consent withdrawn by subject
    46
    46
    52
         Non-compliance with Study Drug
    2
    2
    -
         Physician decision
    5
    2
    3
         Adverse event, non-fatal
    8
    7
    -
         Protocol Deviation
    2
    3
    3
         Randomized but not treated
    4
    4
    1
         Pregnancy
    10
    12
    12
         Withdrawal by Parent/Guardian
    1
    2
    2
         Lost to follow-up
    41
    24
    39

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V160 3-Dose Regimen
    Reporting group description
    		 Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.

    Reporting group title
    V160 2-Dose Regimen
    Reporting group description
    		 Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo by IM injection on Day 1, Month 2, and Month 6.

    Reporting group values
    		 V160 3-Dose Regimen V160 2-Dose Regimen Placebo Total
    Number of subjects
    		 733 733 734 2200
    Age categorical
    Units: Particpants
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 16 15 22 53
        Adults (18-64 years)
    		 717 718 712 2147
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.0 ( 5.0 ) 26.1 ( 4.9 ) 25.9 ( 4.9 ) -
    Sex: Female, Male
    Units: Particpants
        Female
    		 733 733 734 2200
        Male
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 4 5
        Asian
    		 6 7 6 19
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 47 49 43 139
        White
    		 657 652 665 1974
        More than one race
    		 23 23 16 62
        Unknown or Not Reported
    		 0 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 144 145 143 432
        Not Hispanic or Latino
    		 588 585 587 1760
        Unknown or Not Reported
    		 1 3 4 8

    End points

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    End points reporting groups
    Reporting group title
    V160 3-Dose Regimen
    Reporting group description
    		 Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.

    Reporting group title
    V160 2-Dose Regimen
    Reporting group description
    		 Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo by IM injection on Day 1, Month 2, and Month 6.

    Primary: Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection (CMVi) Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)

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    End point title
    		 Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection (CMVi) Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group) [1]
    End point description
    CMVi was defined as the detection of wild-type CMV (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed. Participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 3 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.
    End point type
    Primary
    End point timeframe
    4 weeks post last vaccination (Month 7) up to ~Month 24
    Notes
    [1] - 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: For this endpoint, V160 3-Dose regimen group and the placebo group were the only two arms being evaluated.
    End point values
    		 V160 3-Dose Regimen Placebo
    Number of subjects analysed
    556
    543
    Units: Participants
    14
    24
    Statistical analysis title
    		 Incidence Rate Estimate of V160 3-Dose
    Comparison groups
    V160 3-Dose Regimen v Placebo
    Number of subjects included in analysis
    1099
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Incidence Rate Estimate
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 4.9
    Notes
    [2] - The incidence rate per 100 person years (100 X number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval (CI).
    Statistical analysis title
    		 Vaccine Efficacy V160 3-Dose Regimen
    Comparison groups
    V160 3-Dose Regimen v Placebo
    Number of subjects included in analysis
    1099
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    42.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 71.1
    Notes
    [3] - The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.
    Statistical analysis title
    		 Incidence Rate Estimate of Placebo
    Comparison groups
    Placebo v V160 3-Dose Regimen
    Number of subjects included in analysis
    1099
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Incidence Rate Estimate
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 7.6
    Notes
    [4] - The incidence rate per 100 person years (100 X number of participants with at least 1 event)/first event person-years) is presented along with 95% CI.

    Primary: Number of Participants With Solicited Injection-site Adverse Events

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    End point title
    		 Number of Participants With Solicited Injection-site Adverse Events
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.
    End point type
    Primary
    End point timeframe
    Up to 5 days after each vaccination
    End point values
    		 V160 3-Dose Regimen V160 2-Dose Regimen Placebo
    Number of subjects analysed
    728
    729
    732
    Units: Participants
    683
    668
    249
    Statistical analysis title
    		 V160 3-dose vs. Placebo
    Comparison groups
    V160 3-Dose Regimen v Placebo
    Number of subjects included in analysis
    1460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    59.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 55.8
         upper limit
    		 63.5
    Statistical analysis title
    		 V160 2-dose vs. Placebo
    Comparison groups
    V160 2-Dose Regimen v Placebo
    Number of subjects included in analysis
    1461
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    57.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53.5
         upper limit
    		 61.5

    Primary: Number of Participants With Solicited Systemic AEs

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    End point title
    		 Number of Participants With Solicited Systemic AEs
    End point description
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.
    End point type
    Primary
    End point timeframe
    Up to 14 days after each vaccination
    End point values
    		 V160 3-Dose Regimen V160 2-Dose Regimen Placebo
    Number of subjects analysed
    728
    729
    732
    Units: Participants
    621
    633
    508
    Statistical analysis title
    		 V160 3-dose vs.Placebo
    Comparison groups
    V160 3-Dose Regimen v Placebo
    Number of subjects included in analysis
    1460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.7
         upper limit
    		 20.1
    Statistical analysis title
    		 V160 2-dose vs. Placebo
    Comparison groups
    V160 2-Dose Regimen v Placebo
    Number of subjects included in analysis
    1461
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.3
         upper limit
    		 21.6

    Primary: Number of Participants With Vaccine-related Serious Adverse Events

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    End point title
    		 Number of Participants With Vaccine-related Serious Adverse Events
    End point description
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed. The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.
    End point type
    Primary
    End point timeframe
    Up to 14 days after each vaccination
    End point values
    		 V160 3-Dose Regimen V160 2-Dose Regimen Placebo
    Number of subjects analysed
    728
    729
    732
    Units: Participants
    0
    0
    0
    Statistical analysis title
    		 V160 3-dose vs. Placebo
    Comparison groups
    V160 3-Dose Regimen v Placebo
    Number of subjects included in analysis
    1460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.5
    Statistical analysis title
    		 V160 2-dose vs. Placebo
    Comparison groups
    V160 2-Dose Regimen v Placebo
    Number of subjects included in analysis
    1461
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.5

    Secondary: Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)

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    End point title
    		 Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group) [5]
    End point description
    CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed. The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 2 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.
    End point type
    Secondary
    End point timeframe
    4 weeks post last vaccination (Month 7) up to ~Month 24
    Notes
    [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: For this endpoint, V160 2-Dose regimen group and the placebo group were the only two arms being evaluated.
    End point values
    		 V160 2-Dose Regimen Placebo
    Number of subjects analysed
    546
    543
    Units: Participants
    31
    24
    Statistical analysis title
    		 Incidence Rate Estimate V160 2-Dose
    Comparison groups
    V160 2-Dose Regimen v Placebo
    Number of subjects included in analysis
    1089
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 Incidence Rate Estimate
    Point estimate
    6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 9.5
    Notes
    [6] - The incidence rate per 100 person years (100 X number of participants with at least 1 event)/first event person-years) is presented along with 95% CI.
    Statistical analysis title
    		 Incidence Rate Estimate Placebo
    Comparison groups
    Placebo v V160 2-Dose Regimen
    Number of subjects included in analysis
    1089
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    Parameter type
    		 Incidence Rate Estimate
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 7.6
    Notes
    [7] - The incidence rate per 100 person years (100 X number of participants with at least 1 event)/first event person-years) is presented along with 95% CI.
    Statistical analysis title
    		 Vaccine Efficacy V160 2-Dose
    Comparison groups
    V160 2-Dose Regimen v Placebo
    Number of subjects included in analysis
    1089
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    -32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -135
         upper limit
    		 25
    Notes
    [8] - The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality and serious adverse events: Up to 24 months; Non-serious adverse events: Up to 14 days following any vaccination.
    Adverse event reporting additional description
    The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    V160 3-Dose Group
    Reporting group description
    		 Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.

    Reporting group title
    V160 2-Dose Group
    Reporting group description
    		 Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.

    Reporting group title
    Placebo Group
    Reporting group description
    		 Participants received placebo by IM injection on Day 1, Month 2, and Month 6.

    Serious adverse events
    		 V160 3-Dose Group V160 2-Dose Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 728 (3.02%)
    29 / 729 (3.98%)
    26 / 732 (3.55%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enchondromatosis
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion missed
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    2 / 728 (0.27%)
    6 / 729 (0.82%)
    7 / 732 (0.96%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anembryonic gestation
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    2 / 732 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eclampsia
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    2 / 732 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ruptured ectopic pregnancy
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adnexal torsion
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 728 (0.27%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 728 (0.00%)
    2 / 729 (0.27%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic bone injury
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic arthropathy
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic intracranial hypertension
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 728 (0.14%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 728 (0.00%)
    2 / 729 (0.27%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 728 (0.00%)
    1 / 729 (0.14%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 728 (0.14%)
    2 / 729 (0.27%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 728 (0.00%)
    0 / 729 (0.00%)
    1 / 732 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 728 (0.14%)
    0 / 729 (0.00%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 728 (0.00%)
    2 / 729 (0.27%)
    0 / 732 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V160 3-Dose Group V160 2-Dose Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    697 / 728 (95.74%)
    700 / 729 (96.02%)
    557 / 732 (76.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    434 / 728 (59.62%)
    450 / 729 (61.73%)
    368 / 732 (50.27%)
         occurrences all number
    988
    976
    795
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    457 / 728 (62.77%)
    461 / 729 (63.24%)
    357 / 732 (48.77%)
         occurrences all number
    1128
    1077
    843
    Injection site erythema
         subjects affected / exposed
    254 / 728 (34.89%)
    208 / 729 (28.53%)
    30 / 732 (4.10%)
         occurrences all number
    400
    273
    39
    Injection site pain
         subjects affected / exposed
    680 / 728 (93.41%)
    664 / 729 (91.08%)
    239 / 732 (32.65%)
         occurrences all number
    1943
    1524
    374
    Injection site pruritus
         subjects affected / exposed
    44 / 728 (6.04%)
    26 / 729 (3.57%)
    4 / 732 (0.55%)
         occurrences all number
    54
    34
    5
    Injection site swelling
         subjects affected / exposed
    248 / 728 (34.07%)
    233 / 729 (31.96%)
    21 / 732 (2.87%)
         occurrences all number
    404
    311
    26
    Pyrexia
         subjects affected / exposed
    75 / 728 (10.30%)
    90 / 729 (12.35%)
    27 / 732 (3.69%)
         occurrences all number
    93
    112
    42
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    45 / 728 (6.18%)
    55 / 729 (7.54%)
    46 / 732 (6.28%)
         occurrences all number
    50
    68
    54
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    62 / 728 (8.52%)
    65 / 729 (8.92%)
    69 / 732 (9.43%)
         occurrences all number
    81
    80
    80
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    162 / 728 (22.25%)
    162 / 729 (22.22%)
    76 / 732 (10.38%)
         occurrences all number
    226
    249
    121
    Myalgia
         subjects affected / exposed
    455 / 728 (62.50%)
    424 / 729 (58.16%)
    200 / 732 (27.32%)
         occurrences all number
    996
    818
    336
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    53 / 728 (7.28%)
    53 / 729 (7.27%)
    37 / 732 (5.05%)
         occurrences all number
    59
    56
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2018
    Updated protocol procedures for clarification.
    11 Jun 2019
    Updated congenital cytomegalovirus infection (cCMVi) case definition, clarified the infant sample collection strategy, and adjusted visit schedules to be more accommodating and maintain more contact with study participants.

    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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