Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Observer blinded, randomised study to investigate safety, tolerability and long-term immunogenicity of different dose regimens and formulations of MV-CHIK in healthy volunteers

    Summary
    EudraCT number
    		 2018-000211-25
    Trial protocol
    		 GB  
    Global end of trial date
    16 Nov 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Nov 2021
    First version publication date
    09 Sep 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V184-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03635086
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MV-CHIK-205: Themisbio, 2018-000211-25: EudraCT Number
    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
    16 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) in different dose regimens, 28 days after one or two vaccinations.
    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
    22 Aug 2018
    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
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After completion of screening procedures, participants will be randomized to one of five treatment groups (A, B, C, D or E).

    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, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A: Two MV-CHIK Lyophilized Low Dose
    Arm description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MV-CHIK lyophilised formulation, low dose
    Investigational medicinal product code
    MV-CHIK
    Other name
    V184
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose

    Arm title
    		 Group B: Two MV-CHIK Liquid Frozen Low Dose
    Arm description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MV-CHIK liquid frozen formulation, low dose
    Investigational medicinal product code
    MV-CHIK
    Other name
    V184
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.

    Arm title
    		 Group C: Two MV-CHIK Liquid Low Dose SPS®
    Arm description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MV-CHIK SPS® formulation, low dose
    Investigational medicinal product code
    MV-CHIK
    Other name
    V184
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.

    Arm title
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Arm description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MV-CHIK liquid frozen formulation, high dose
    Investigational medicinal product code
    MV-CHIK
    Other name
    V184
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.

    Arm title
    		 Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Arm description
    		 Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MV-CHIK liquid frozen formulation high dose/placebo
    Investigational medicinal product code
    MV-CHIK/Placebo
    Other name
    V184
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose. Placebo was sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.

    Investigational medicinal product name
    MV-CHIK liquid frozen formulation, high dose
    Investigational medicinal product code
    MV-CHIK
    Other name
    V184
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.

    Number of subjects in period 1
    		Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Started
    12
    12
    12
    12
    12
    Completed
    11
    11
    11
    12
    12
    Not completed
    1
    1
    1
    0
    0
         Consent withdrawn by subject
    -
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    1
    -
    -
    -
         Lost to follow-up
    1
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group A: Two MV-CHIK Lyophilized Low Dose
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.

    Reporting group title
    Group B: Two MV-CHIK Liquid Frozen Low Dose
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.

    Reporting group title
    Group C: Two MV-CHIK Liquid Low Dose SPS®
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.

    Reporting group title
    Group D: Two MV-CHIK Liquid Frozen High Dose
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.

    Reporting group title
    Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Reporting group description
    		 Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.

    Reporting group values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo Total
    Number of subjects
    		 12 12 12 12 12 60
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.9 ( 9.52 ) 34.6 ( 11.79 ) 39.0 ( 11.60 ) 36.3 ( 9.62 ) 36.8 ( 7.52 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 3 4 4 6 6 23
        Male
    		 9 8 8 6 6 37
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 0 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0
        White
    		 12 12 12 12 12 60
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group A: Two MV-CHIK Lyophilized Low Dose
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.

    Reporting group title
    Group B: Two MV-CHIK Liquid Frozen Low Dose
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.

    Reporting group title
    Group C: Two MV-CHIK Liquid Low Dose SPS®
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.

    Reporting group title
    Group D: Two MV-CHIK Liquid Frozen High Dose
    Reporting group description
    		 Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.

    Reporting group title
    Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Reporting group description
    		 Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.

    Primary: Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination

    		 Close Top of page
    End point title
    		 Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
    End point description
    Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50). Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed. Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer. The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
    End point type
    Primary
    End point timeframe
    28 days after last vaccination (Up to Day 56)
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    11
    11
    9
    11
    11
    Units: Titer
        geometric mean (confidence interval 95%)
    21.0 (9.9 to 44.5)
    19.1 (9.0 to 40.5)
    13.6 (5.9 to 31.2)
    45.7 (21.6 to 97.0)
    8.9 (4.2 to 18.8)
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9998
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 4.9
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9345
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 7.5
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5836
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.1
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4844
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 10.6
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9725
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 6.8
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5969
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 9.6
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4715
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.9
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9388
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 7.4
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2043
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.4
    Statistical analysis title
    		 Anti-Chikungunya Antibodies by PRNT50- 28 days
    Statistical analysis description
    GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0251
    Method
    		 Tukey-Kramer
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 23.1

    Secondary: Percentage of Participants with Solicited and Unsolicited Adverse Events

    		 Close Top of page
    End point title
    		 Percentage of Participants with Solicited and Unsolicited Adverse Events
    End point description
    An adverse event (AE) includes any untoward medical occurrence in a participant to whom an IMP has been administered, not necessarily caused by or related to that product. An AE can therefore be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease temporally associated with the use of an IMP whether or not considered related to the IMP. The percentage of participants with solicited and unsolicited AEs was assessed. The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    12
    12
    12
    12
    12
    Units: Percentage of Participants
        number (not applicable)
    83.3
    91.7
    58.3
    83.3
    91.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with at Least 1 Serious Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with at Least 1 Serious Adverse Event
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and consists of a congenital anomaly, birth defect or other important medical events. The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    12
    12
    12
    12
    12
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50

    		 Close Top of page
    End point title
    		 Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
    End point description
    Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of antibody response by PRNT50. These results represent geometric mean titers (titers <10 were set to 5 for protocol-specified analysis). The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
    End point type
    Secondary
    End point timeframe
    Up to Day 365
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    12
    12
    12
    12
    12
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 0 (n=11, 11, 10, 11, 11)
    5.0 (3.0 to 8.2)
    8.6 (5.3 to 14.2)
    5.0 (3.0 to 8.4)
    5.0 (3.0 to 8.2)
    5.0 (3.0 to 8.2)
        Day 28 (n=11, 11, 10, 11, 11)
    7.2 (3.9 to 13.2)
    14.0 (7.6 to 25.6)
    6.3 (3.4 to 11.9)
    11.3 (6.2 to 20.8)
    8.9 (4.8 to 16.2)
        Day 56 (n=11, 11, 9, 11, 11)
    21.0 (10.1 to 43.7)
    19.1 (9.2 to 39.7)
    13.6 (6.0 to 30.5)
    45.7 (22.0 to 95.2)
    6.9 (3.3 to 14.3)
        Day 182 (n=11, 11, 10, 11, 11)
    13.8 (7.0 to 27.2)
    18.2 (9.2 to 35.9)
    10.5 (5.1 to 21.5)
    11.8 (6.0 to 23.4)
    6.8 (3.4 to 13.5)
        Day 365 (n=10, 11, 9, 11, 11)
    7.2 (3.9 to 13.6)
    11.8 (6.5 to 21.5)
    8.9 (4.6 to 17.2)
    8.3 (4.6 to 15.0)
    5.0 (2.8 to 9.1)
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5263
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.55
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 4.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5263
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 4.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5263
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 4.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5321
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9983
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.9
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9882
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 2.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8234
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 2.1
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3778
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 7.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9878
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.1
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8213
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 5.3
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6716
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.9
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.938
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 2.5
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9777
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.3
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9287
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 7.2
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9997
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 4.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5598
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2117
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 13.1
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9699
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 6.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.292
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 11.9
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.446
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.184
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.4
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7229
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 9.2
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0052
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 28.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9777
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 3
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9812
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 5.3
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9979
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 4.5
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7973
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.588
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 7.9
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2602
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 10.4
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8992
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9991
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 3.6
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9028
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 6.2
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9915
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 2.9
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7833
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 2.1
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7761
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 6.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.998
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.909
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.9
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9651
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9112
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.7
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9999
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6953
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 6.2
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.257
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 7.8
    Statistical analysis title
    		 Anti-Chik Antibodies by PRNT50- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7523
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 5.4

    Secondary: Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells [1]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD4+CD69+ (Day 0)
    0.0194 ( 0.0446 )
        CD4+CD69+ (Day 14)
    0.1430 ( 0.1589 )
        CD4+CD69+ (Day 28)
    0.1077 ( 0.2060 )
        CD4+CD69+ (Day 42)
    0.2050 ( 0.2316 )
        CD4+CD69+ (Day 56)
    0.1935 ( 0.2036 )
    No statistical analyses for this end point

    Secondary: Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells [2]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, a subset of the participants in treatment group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    Notes
    [2] - 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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD4+CD69+CD137+ (Day 0)
    0.0061 ( 0.0112 )
        CD4+CD69+CD137+ (Day 14)
    0.0174 ( 0.0313 )
        CD4+CD69+CD137+ (Day 28)
    0.0120 ( 0.0168 )
        CD4+CD69+CD137+ (Day 42)
    0.0317 ( 0.0438 )
        CD4+CD69+CD137+ (Day 56)
    0.0393 ( 0.0476 )
    No statistical analyses for this end point

    Secondary: Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells [3]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    Notes
    [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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD4+CD137+ (Day 0)
    0.0528 ( 0.0509 )
        CD4+CD137+ (Day 14)
    0.1595 ( 0.2105 )
        CD4+CD137+ (Day 28)
    0.1492 ( 0.0932 )
        CD4+CD137+ (Day 42)
    0.3484 ( 0.3428 )
        CD4+CD137+ (Day 56)
    0.3994 ( 0.2713 )
    No statistical analyses for this end point

    Secondary: Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells [4]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    Notes
    [4] - 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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD4+CD69+OX40+ (Day 0)
    0.0033 ( 0.0048 )
        CD4+CD69+OX40+ (Day 14)
    0.0265 ( 0.0522 )
        CD4+CD69+OX40+ (Day 28)
    0.0095 ( 0.0070 )
        CD4+CD69+OX40+ (Day 42)
    0.0267 ( 0.0408 )
        CD4+CD69+OX40+ (Day 56)
    0.0337 ( 0.0386 )
    No statistical analyses for this end point

    Secondary: Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells [5]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD4+OX40+ (Day 0)
    0.0062 ( 0.0158 )
        CD4+OX40+ (Day 14)
    0.0745 ( 0.1007 )
        CD4+OX40+ (Day 28)
    0.0269 ( 0.0280 )
        CD4+OX40+ (Day 42)
    0.0492 ( 0.1012 )
        CD4+OX40+ (Day 56)
    0.0698 ( 0.0997 )
    No statistical analyses for this end point

    Secondary: Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells [6]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    Notes
    [6] - 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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD8+CD69+ (Day 0)
    0.1919 ( 0.2329 )
        CD8+CD69+ (Day 14)
    0.3319 ( 0.6046 )
        CD8+CD69+ (Day 28)
    0.4242 ( 0.6330 )
        CD8+CD69+ (Day 42)
    0.1961 ( 0.2496 )
        CD8+CD69+ (Day 56)
    0.2375 ( 0.2902 )
    No statistical analyses for this end point

    Secondary: Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells [7]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    Notes
    [7] - 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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD8+CD69+CD137+ (Day 0)
    0.0005 ( 0.0018 )
        CD8+CD69+CD137+ (Day 14)
    0.0139 ( 0.0229 )
        CD8+CD69+CD137+ (Day 28)
    0.0184 ( 0.0454 )
        CD8+CD69+CD137+ (Day 42)
    0.0148 ( 0.0171 )
        CD8+CD69+CD137+ (Day 56)
    0.0380 ( 0.0392 )
    No statistical analyses for this end point

    Secondary: Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells

    		 Close Top of page
    End point title
    		 Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells [8]
    End point description
    Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants. The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    Notes
    [8] - 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: Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
    End point values
    		 Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects analysed
    11
    Units: Percentage of t-cells
    arithmetic mean (standard deviation)
        CD8+CD137+ (Day 0)
    0.0194 ( 0.0334 )
        CD8+CD137+ (Day 14)
    0.0294 ( 0.0366 )
        CD8+CD137+ (Day 28)
    0.0224 ( 0.0377 )
        CD8+CD137+ (Day 42)
    0.0341 ( 0.0595 )
        CD8+CD137+ (Day 56)
    0.0607 ( 0.0557 )
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay

    		 Close Top of page
    End point title
    		 Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
    End point description
    Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of Chikungunya antibody response by enzyme linked immunosorbent assay (ELISA). The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
    End point type
    Secondary
    End point timeframe
    Up to Day 365
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    12
    12
    12
    12
    12
    Units: Titer
    geometric mean (standard deviation)
        Day 0 (n=11, 11, 10, 11, 11)
    7.4 ( 0.0 )
    14.5 ( 3907.50 )
    7.4 ( 0.0 )
    7.4 ( 0.0 )
    7.4 ( 0.0 )
        Day 28 (n=11, 11, 10, 11, 11)
    9.7 ( 46.83 )
    17.8 ( 4009.38 )
    8.1 ( 3.69 )
    14.1 ( 28.47 )
    13.1 ( 8.74 )
        Day 56 (n=11, 11, 10, 11, 11)
    54.3 ( 306.39 )
    90.0 ( 4369.43 )
    54.7 ( 112.29 )
    171.4 ( 307.41 )
    9.8 ( 7.69 )
        Day 182 (n=11, 11, 10, 11, 11)
    15.6 ( 112.90 )
    26.9 ( 3304.35 )
    16.3 ( 92.58 )
    26.5 ( 17.36 )
    8.1 ( 4.66 )
        Day 365 (n=10, 11, 9, 11, 11)
    11.9 ( 112.80 )
    23.8 ( 3087.93 )
    15.8 ( 75.39 )
    18.9 ( 18.52 )
    9.4 ( 10.01 )
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5263
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.5
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.5
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5263
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 6.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.55
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5263
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 6.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 0)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 3.5
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7708
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9503
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 3
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9791
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 3.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5739
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 9.8
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9966
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 5.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9748
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 5.9
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.827
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.6
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9918
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 5.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.893
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.8
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 28)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9999
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 4.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9105
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 5.5
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9213
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 9.1
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8092
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.8
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0423
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 29.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3047
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.004
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 48.5
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 92.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0488
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 30.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 56)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3347
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.8
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8831
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8916
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.1
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 5.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group E: One MV-CHIK Liquid Frozen High Dose/Placebo v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2563
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 17.1
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 5.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9169
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 8.9
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.794
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 9.9
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7708
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 10.8
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9237
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.3
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 182)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2661
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 16.9
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group B: Two MV-CHIK Liquid Frozen Low Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7614
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.6
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9905
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 4.3
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.933
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.3
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group A: Two MV-CHIK Lyophilized Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9945
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 6.7
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group C: Two MV-CHIK Liquid Low Dose SPS®
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9599
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 8.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9942
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 6.4
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group B: Two MV-CHIK Liquid Frozen Low Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4932
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 12.9
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group D: Two MV-CHIK Liquid Frozen High Dose
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9983
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 4.6
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group D: Two MV-CHIK Liquid Frozen High Dose v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7431
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 10.2
    Statistical analysis title
    		 Anti-Chik Antibodies by ELISA- 365 days (Day 365)
    Statistical analysis description
    Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.
    Comparison groups
    Group C: Two MV-CHIK Liquid Low Dose SPS® v Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9112
    Method
    		 ANOVA
    Parameter type
    		 Geometric Mean Ratio Estimate
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 9.3

    Secondary: Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA

    		 Close Top of page
    End point title
    		 Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
    End point description
    Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA. The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    11
    11
    10
    11
    11
    Units: Titer
    geometric mean (standard deviation)
        Day 0 (n=11, 11, 10, 11, 11)
    711.6 ( 1764.77 )
    482.1 ( 1009.40 )
    750.2 ( 1580.90 )
    731.0 ( 1612.98 )
    888.4 ( 1560.14 )
        Day 28 (n=11, 11, 10, 11, 11)
    1250.8 ( 1629.35 )
    1120.3 ( 849.01 )
    1207.7 ( 1642.33 )
    2246.4 ( 1515.40 )
    2116.2 ( 1527.25 )
        Day 56 (n=11, 11, 10, 11, 11)
    1476.8 ( 1672.10 )
    1158.6 ( 1019.59 )
    1355.4 ( 1818.08 )
    3009.8 ( 1355.67 )
    2011.8 ( 1852.26 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE

    		 Close Top of page
    End point title
    		 Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value. The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    12
    12
    12
    12
    12
    Units: Participants
    1
    0
    0
    0
    4
    No statistical analyses for this end point

    Secondary: Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE

    		 Close Top of page
    End point title
    		 Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value. The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 56
    End point values
    		 Group A: Two MV-CHIK Lyophilized Low Dose Group B: Two MV-CHIK Liquid Frozen Low Dose Group C: Two MV-CHIK Liquid Low Dose SPS® Group D: Two MV-CHIK Liquid Frozen High Dose Group E: One MV-CHIK Liquid Frozen High Dose/Placebo
    Number of subjects analysed
    12
    12
    12
    12
    12
    Units: Participants
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
    Adverse event reporting additional description
    The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose on day 0 and day 28.

    Reporting group title
    Group B
    Reporting group description
    		 Participants received two vaccinations with MV-CHIK liquid low dose frozen formulation on day 0 and day 28.

    Reporting group title
    Group C
    Reporting group description
    		 Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28.

    Reporting group title
    Group D
    Reporting group description
    		 Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28.

    Reporting group title
    Group E
    Reporting group description
    		 Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28.

    Serious adverse events
    		 Group A Group B Group C Group D Group E
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A Group B Group C Group D Group E
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 12 (83.33%)
    11 / 12 (91.67%)
    7 / 12 (58.33%)
    10 / 12 (83.33%)
    11 / 12 (91.67%)
    Vascular disorders
    Pallor
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    3
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
         occurrences all number
    1
    1
    3
    1
    3
    Injection site erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    3
    2
    2
    Injection site induration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    2
    2
    3
    Injection site pain
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    3 / 12 (25.00%)
    8 / 12 (66.67%)
    7 / 12 (58.33%)
         occurrences all number
    3
    5
    6
    15
    7
    Injection site pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    3
    0
    Injection site swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    3
    2
    3
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Vulvovaginal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    3
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Sinus pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    0
    0
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    Headache
         subjects affected / exposed
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
         occurrences all number
    8
    7
    7
    7
    6
    Paraesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Excessive cerumen production
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    3
    1
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Limb discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2018
    Amendment 1.3- Primary reason for amendment was to adjust the safety stopping rules for participants who develop serious adverse reaction (SAR); Another change was including additional information for pregnancy test and contraception; added description of the circumstances in which a woman was considered of childbearing potential.
    21 Aug 2018
    Amendment 1.4- Primary reason for amendment was to change the Principal Investigator name and phone number; another change was in the volume of reconstitution for the lyophilized product (from 0.4 mL/dose to 0.5 mL/dose) and change in the injection volume (from 0.3 mL/dose to 0.4 mL/dose)

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 17:34:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA