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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000211-25 | EudraCT Number | ||
| MV-CHIK-205 | Other Identifier | Themisbio |
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The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Two MV-CHIK lyophilized low dose | Experimental | Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28. |
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| Group B: Two MV-CHIK liquid frozen low dose | Experimental | Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28. |
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| Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®) | Experimental | Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28. |
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| Group D: Two MV-CHIK liquid frozen high dose | Experimental | Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28. |
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| Group E: One MV-CHIK liquid frozen high dose/placebo | Experimental | Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MV-CHIK lyophilised formulation, low dose | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 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. | 28 days after last vaccination (Up to Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited and Unsolicited Adverse Events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Belfast | Belfast | Northern Ireland | BT9 6 AD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25739878 | Result | Ramsauer K, Schwameis M, Firbas C, Mullner M, Putnak RJ, Thomas SJ, Despres P, Tauber E, Jilma B, Tangy F. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2. |
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After completion of screening procedures, participants will be randomized to one of five treatment groups (A, B, C, D or E).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Two Measles Virus-Chikungunya (MV-CHIK) Lyophilized Low Dose | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 |
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| MV-CHIK liquid frozen formulation, low dose | Biological | 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. |
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| MV-CHIK SPS® formulation, low dose | Biological | 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. |
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| MV-CHIK liquid frozen formulation, high dose | Biological | 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. |
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| Placebo | Other | Sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection. |
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| Up to Day 56 |
| Percentage of Participants With at Least 1 Serious Adverse Event | 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. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations. | Up to Day 56 |
| Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | 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). | Up to Day 365 |
| Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | Cellular immunogenicity will be 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 subjects. | Up to Day 56 |
| Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | 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. | Up to Day 56 |
| Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | 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 of variance GMT of Chikungunya-ELISA antibodies between treatment groups is summarized. | Up to Day 365 |
| Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA. | Up to Day 56 |
| Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 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. | Up to Day 56 |
| Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 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. | Up to Day 56 |
| FG001 | Group B: Two MV-CHIK Liquid Frozen Low Dose | 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. |
| FG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. |
| FG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| FG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Two MV-CHIK Lyophilized Low Dose | 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. |
| BG001 | Group B: Two MV-CHIK Liquid Frozen Low Dose | 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. |
| BG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. |
| BG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| BG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 28 days after last vaccination (Up to Day 56) |
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| Secondary | Percentage of Participants With Solicited and Unsolicited Adverse Events | 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. | Posted | Number | Percentage of Participants | Up to Day 56 |
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| Secondary | Percentage of Participants With at Least 1 Serious Adverse Event | 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. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations. | 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. | Posted | Number | Percentage of Participants | Up to Day 56 |
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| Secondary | Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50 | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Up to Day 365 |
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| Secondary | Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells | Cellular immunogenicity will be 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 subjects. | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells | 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. | Posted | Mean | Standard Deviation | Percentage of t-cells | Up to Day 56 |
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| Secondary | Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay | 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 of variance GMT of Chikungunya-ELISA antibodies between treatment groups is summarized. | 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. | Posted | Geometric Mean | Standard Deviation | Titer | Up to Day 365 |
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| Secondary | Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA | 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. | Posted | Geometric Mean | Standard Deviation | Titer | Up to Day 56 |
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| Secondary | Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE | 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. | Posted | Count of Participants | Participants | Up to Day 56 |
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| Secondary | Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE | 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. | Posted | Count of Participants | Participants | Up to Day 56 |
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Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Two MV-CHIK Lyophilized Low Dose | 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. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG001 | Group B: Two MV-CHIK Liquid Frozen Low Dose | 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. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. | 0 | 12 | 0 | 12 | 11 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Excessive cerumen production | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Pallor | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Aug 17, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 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. | Tukey-Kramer | 0.9345 | Geometric Mean Ratio Estimate | 1.5 | 2-Sided | 95 | 0.3 | 7.5 | Other |
| 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. | Tukey-Kramer | 0.5836 | Geometric Mean Ratio Estimate | 0.5 | 2-Sided | 95 | 0.1 | 2.1 | Other |
| 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. | Tukey-Kramer | 0.4844 | Geometric Mean Ratio Estimate | 2.4 | 2-Sided | 95 | 0.5 | 10.6 | Other |
| 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. | Tukey-Kramer | 0.9725 | Geometric Mean Ratio Estimate | 1.4 | 2-Sided | 95 | 0.3 | 6.8 | Other |
| 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. | Tukey-Kramer | 0.4715 | Geometric Mean Ratio Estimate | 0.4 | 2-Sided | 95 | 0.1 | 1.9 | Other |
| 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. | Tukey-Kramer | 0.5969 | Geometric Mean Ratio Estimate | 2.2 | 2-Sided | 95 | 0.5 | 9.6 | Other |
| 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. | Tukey-Kramer | 0.2043 | Geometric Mean Ratio Estimate | 0.3 | 2-Sided | 95 | 0.1 | 1.4 | Other |
| 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. | Tukey-Kramer | 0.9388 | Geometric Mean Ratio Estimate | 1.5 | 2-Sided | 95 | 0.3 | 7.4 | Other |
| 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. | Tukey-Kramer | 0.0251 | Geometric Mean Ratio Estimate | 5.2 | 2-Sided | 95 | 1.2 | 23.1 | Other |
| OG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. |
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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| OG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. |
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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|
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. |
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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| Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) |
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. |
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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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.
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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| OG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. |
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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| OG002 | Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®) | 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. |
| OG003 | Group D: Two MV-CHIK Liquid Frozen High Dose | 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. |
| OG004 | Group E: One MV-CHIK Liquid Frozen High Dose | 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. |
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