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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) in Healthy Adults

    Summary
    EudraCT number
    		 2020-004501-30
    Trial protocol
    		 DE   FI  
    Global end of trial date
    07 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2025
    First version publication date
    10 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V181-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05507450
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue,, Rahway, NJ, United States, P.O. Box 2000
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.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
    05 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) foreach of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.
    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
    07 Sep 2022
    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: 230
    Country: Number of subjects enrolled
    Canada: 173
    Country: Number of subjects enrolled
    Finland: 178
    Country: Number of subjects enrolled
    Germany: 235
    Country: Number of subjects enrolled
    Israel: 152
    Country: Number of subjects enrolled
    Taiwan: 40
    Country: Number of subjects enrolled
    United States: 263
    Worldwide total number of subjects
    1271
    EEA total number of subjects
    413
    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)
    0
    Adults (18-64 years)
    1271
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult males or females, in generally good health, between 18 to 50 years of age, and without a history of dengue or Zika natural infection or prior receipt of any other dengue vaccine were enrolled in this study.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V181 High-Potency Level Group
    Arm description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V181
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.

    Arm title
    		 V181 Mid-Potency Level Group
    Arm description
    		 Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V181
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.

    Arm title
    		 V181 Low-Potency Level Group
    Arm description
    		 Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V181
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a single SC 0.5 mL dose of placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single 0.5 mL SC dose of placebo.

    Number of subjects in period 1
    		V181 High-Potency Level Group V181 Mid-Potency Level Group V181 Low-Potency Level Group Placebo
    Started
    231
    463
    461
    116
    Vaccinated at baseline
    231
    461
    459
    115
    Completed
    205
    430
    431
    106
    Not completed
    26
    33
    30
    10
         Adverse event, serious fatal
    -
    -
    1
    -
         Consent withdrawn by subject
    4
    11
    7
    3
         Randomized By Mistake Without Study Treatment
    -
    2
    1
    -
         Participant left the country
    -
    -
    1
    -
         Lost to follow-up
    22
    20
    20
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V181 High-Potency Level Group
    Reporting group description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.

    Reporting group title
    V181 Mid-Potency Level Group
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.

    Reporting group title
    V181 Low-Potency Level Group
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single SC 0.5 mL dose of placebo.

    Reporting group values
    		 V181 High-Potency Level Group V181 Mid-Potency Level Group V181 Low-Potency Level Group Placebo Total
    Number of subjects
    		 231 463 461 116 1271
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 231 463 461 116 1271
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 33.8 ( 9.5 ) 33.1 ( 9.8 ) 33.3 ( 9.3 ) 33.2 ( 9.1 ) -
    Sex/Gender, Customized
    Units:
        Female
    		 129 265 262 59 715
        Male
    		 102 198 198 57 555
        Undifferentiated
    		 0 0 1 0 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 2 0 3
        Asian
    		 15 32 33 6 86
        Native Hawaiian or Other Pacific Islander
    		 1 3 2 0 6
        Black or African American
    		 5 12 14 9 40
        White
    		 207 406 400 100 1113
        More than one race
    		 2 10 10 1 23
        Unknown or Not Reported
    		 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 31 51 55 20 157
        Not Hispanic or Latino
    		 195 396 389 94 1074
        Unknown or Not Reported
    		 5 16 17 2 40

    End points

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    End points reporting groups
    Reporting group title
    V181 High-Potency Level Group
    Reporting group description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.

    Reporting group title
    V181 Mid-Potency Level Group
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.

    Reporting group title
    V181 Low-Potency Level Group
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single SC 0.5 mL dose of placebo.

    Primary: Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)

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    End point title
    		 Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) [1]
    End point description
    A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination. The population analyzed was all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. These deviations include participant was seropositive at baseline as assessed by VRNT and missing serology results.
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 V181 High-Potency Level Group V181 Mid-Potency Level Group V181 Low-Potency Level Group Placebo
    Number of subjects analysed
    178
    377
    380
    99
    Units: Titer
    geometric mean (confidence interval 95%)
        DENV1 Serotype
    326.31 (256.52 to 415.08)
    261.10 (220.90 to 308.61)
    184.85 (153.89 to 222.03)
    10.33 (8.79 to 12.14)
        DENV2 Serotype
    815.79 (674.69 to 986.40)
    766.98 (683.66 to 860.45)
    854.59 (755.07 to 967.22)
    7.50 (7.50 to 7.50)
        DENV3 Serotype
    203.04 (162.87 to 253.12)
    135.19 (115.70 to 157.97)
    94.69 (78.92 to 113.61)
    7.20 (6.11 to 8.48)
        DENV4 Serotype
    102.13 (77.08 to 135.33)
    68.33 (55.80 to 83.67)
    64.43 (52.42 to 79.19)
    6.50 (6.50 to 6.50)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) [2]
    End point description
    An SAE is an AE that results in death, 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 will be determined by the investigator. The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Primary
    End point timeframe
    Up to 28 days post-vaccination
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 V181 High-Potency Level Group V181 Mid-Potency Level Group V181 Low-Potency Level Group Placebo
    Number of subjects analysed
    231
    461
    459
    115
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)

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    End point title
    		 Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs include pain, erythema (redness), and swelling. The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to 5 days post-vaccination
    End point values
    		 V181 High-Potency Level Group V181 Mid-Potency Level Group V181 Low-Potency Level Group Placebo
    Number of subjects analysed
    231
    461
    459
    115
    Units: Percentage of participants
    number (not applicable)
        Injection site erythema
    35.5
    21.7
    15.0
    1.7
        Injection site pain
    34.2
    19.7
    13.5
    14.8
        Injection site swelling
    10.0
    5.4
    2.4
    2.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Systemic AEs

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    End point title
    		 Percentage of Participants With Solicited Systemic AEs
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include rash, headache, fatigue (tiredness), pyrexia (oral temperature ≥100.4 °F or 38.0 °C), myalgia (muscle pain), and arthralgia (joint pain). The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to 28 days post-vaccination
    End point values
    		 V181 High-Potency Level Group V181 Mid-Potency Level Group V181 Low-Potency Level Group Placebo
    Number of subjects analysed
    231
    461
    459
    115
    Units: Percentage of participants
    number (not applicable)
        Fatigue
    52.8
    48.6
    44.0
    33.9
        Pyrexia
    10.8
    7.6
    5.7
    0.9
        Arthralgia
    21.2
    12.6
    13.1
    7.8
        Myalgia
    32.0
    26.5
    24.0
    18.3
        Headache
    54.5
    49.9
    46.2
    47.0
        Rash
    55.8
    64.0
    68.6
    8.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination
    Adverse event reporting additional description
    All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    V181 High Potency Level
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine

    Reporting group title
    V181 Mid Potency Level
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine

    Reporting group title
    V181 Low Potency Level
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of placebo

    Serious adverse events
    		 V181 High Potency Level V181 Mid Potency Level V181 Low Potency Level Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 231 (3.46%)
    9 / 461 (1.95%)
    12 / 459 (2.61%)
    6 / 115 (5.22%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid cancer
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         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
    Cancer pain
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Biochemical pregnancy
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Abortion spontaneous
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Psychiatric disorders
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Psychotic disorder
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Self-destructive behaviour
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Suicidal ideation
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         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
    Suicide attempt
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    2 / 459 (0.44%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Depression
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Injury, poisoning and procedural complications
    Ligament injury
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Fibula fracture
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Meniscus injury
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Concussion
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Buttock injury
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Post procedural bile leak
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Tendon rupture
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Cardiac disorders
    Hypertensive heart disease
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Tooth impacted
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         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
    Inguinal hernia
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondromalacia
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         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
    Rhabdomyolysis
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Diverticulitis
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         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
    Cellulitis
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Scrotal abscess
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    1 / 115 (0.87%)
         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
    Osteomyelitis
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 461 (0.00%)
    1 / 459 (0.22%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex encephalitis
         subjects affected / exposed
    1 / 231 (0.43%)
    0 / 461 (0.00%)
    0 / 459 (0.00%)
    0 / 115 (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
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 231 (0.00%)
    1 / 461 (0.22%)
    0 / 459 (0.00%)
    0 / 115 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V181 High Potency Level V181 Mid Potency Level V181 Low Potency Level Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    199 / 231 (86.15%)
    402 / 461 (87.20%)
    405 / 459 (88.24%)
    78 / 115 (67.83%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    126 / 231 (54.55%)
    230 / 461 (49.89%)
    212 / 459 (46.19%)
    54 / 115 (46.96%)
         occurrences all number
    131
    240
    230
    56
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    4 / 231 (1.73%)
    12 / 461 (2.60%)
    24 / 459 (5.23%)
    0 / 115 (0.00%)
         occurrences all number
    4
    13
    24
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    122 / 231 (52.81%)
    224 / 461 (48.59%)
    202 / 459 (44.01%)
    39 / 115 (33.91%)
         occurrences all number
    125
    231
    212
    43
    Injection site erythema
         subjects affected / exposed
    85 / 231 (36.80%)
    107 / 461 (23.21%)
    76 / 459 (16.56%)
    2 / 115 (1.74%)
         occurrences all number
    89
    108
    76
    2
    Injection site pain
         subjects affected / exposed
    80 / 231 (34.63%)
    91 / 461 (19.74%)
    69 / 459 (15.03%)
    18 / 115 (15.65%)
         occurrences all number
    80
    92
    69
    18
    Injection site swelling
         subjects affected / exposed
    23 / 231 (9.96%)
    25 / 461 (5.42%)
    12 / 459 (2.61%)
    3 / 115 (2.61%)
         occurrences all number
    23
    25
    12
    3
    Pyrexia
         subjects affected / exposed
    25 / 231 (10.82%)
    35 / 461 (7.59%)
    26 / 459 (5.66%)
    1 / 115 (0.87%)
         occurrences all number
    25
    35
    26
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 231 (5.63%)
    9 / 461 (1.95%)
    15 / 459 (3.27%)
    3 / 115 (2.61%)
         occurrences all number
    15
    12
    15
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    12 / 231 (5.19%)
    26 / 461 (5.64%)
    25 / 459 (5.45%)
    5 / 115 (4.35%)
         occurrences all number
    12
    26
    26
    5
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    129 / 231 (55.84%)
    295 / 461 (63.99%)
    315 / 459 (68.63%)
    10 / 115 (8.70%)
         occurrences all number
    131
    295
    315
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    49 / 231 (21.21%)
    58 / 461 (12.58%)
    60 / 459 (13.07%)
    9 / 115 (7.83%)
         occurrences all number
    50
    58
    60
    9
    Myalgia
         subjects affected / exposed
    74 / 231 (32.03%)
    122 / 461 (26.46%)
    110 / 459 (23.97%)
    21 / 115 (18.26%)
         occurrences all number
    75
    125
    112
    21
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 231 (5.19%)
    31 / 461 (6.72%)
    15 / 459 (3.27%)
    4 / 115 (3.48%)
         occurrences all number
    12
    31
    15
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Aug 2022
    Amendment 1: Provide the potency levels for V181 and to extend the contraception requirements from 4 weeks after administration of study intervention to 90 days after administration of study intervention.

    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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