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MV-CHIK-202: Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine

Sponsor
Themis Bioscience GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT02861586
Collaborator
(none)
263
Enrollment
4
Locations
8
Arms
19.9
Actual Duration (Months)
65.8
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.

Condition or Disease Intervention/Treatment Phase
  • Biological: MV-CHIK low dose
  • Biological: MV-CHIK high dose
  • Biological: Priorix®
  • Biological: physiological saline solution
 Phase 2

Detailed Description

This is a double blinded, block-randomized, active- and placebo controlled, phase II trial, comparing two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK (a novel vaccine against Chikungunya virus).

Healthy male and female subjects aged 18-55 years will be randomized to one of six treatment groups (A, B, C. D, M1 or M2) differing in dosage and scheduling of vaccinations. Group A-D will be split in one arm receiving MV-CHIK and one control-arm receiving Priorix®.

All subjects of group A. B, C and D will receive three i.m. injections on study day 0, 28 and 196. Subjects of group A and B will receive MV-CHIK low dose or control-vaccine Priorix® (or equivalent measles vaccine) and subjects of group C and D will be treated with MV-CHIK high dose or control-vaccine (Priorix® or equivalent measles vaccine).

All subjects of group A, B, C and D additionally will be randomized to one of two treatment sequences: group A and C will receive MV-CHIK or control-vaccine Priorix® on study day 0 and 28, followed by placebo on day 196, and group B and D receive placebo on day 0 and MV-CHIK or Priorix® on day 28, followed by an additional vaccination of the same product on day196 (boosting vaccination).

All subjects of the measles booster group M1 and M2 will receive five i.m. injections on study day -28, 0, 28, 168 and 196. The first vaccination will be Priorix® (or equivalent measles vaccine) on study day -28. Group M1 will receive MV-CHIK vaccinations on day 0 and day 28 and placebo on day 168 and 196. Group M2 will receive placebo on day 0 and 28 and MV-CHIK on day 168 and on day 196.

All subjects will be followed for safety and immunogenicity evaluation until day 224. Study duration per subject is estimated to be 33-37 weeks (~8 months), respectively.

Study Design

Study Type:
Interventional
Actual Enrollment :
263 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Double Blinded, Randomized, Priorix®- and Placebo-controlled, Trial to Evaluate the Optimal Dose of MV-CHIK Vaccine (Against Chikungunya Virus) in Regard to Immunogenicity, Safety and Tolerability in Healthy Volunteers
Actual Study Start Date :
Aug 17, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Apr 16, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group A; MV-CHIK low

60 subjects will receive i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

Biological: MV-CHIK low dose
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
Other Names:
  • vaccine against Chikungunya

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Active Comparator: Treatment Group A/C; Priorix®

    20 subjects will receive i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: Priorix®
    lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
    Other Names:
  • vaccine against Measles, Mumps and Rubella

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Experimental: Treatment Group B; MV-CHIK low

    60 subjects will receive i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: MV-CHIK low dose
    recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
    Other Names:
  • vaccine against Chikungunya

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Active Comparator: Treatment Group B/D; Priorix®

    20 subjects will receive i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: Priorix®
    lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
    Other Names:
  • vaccine against Measles, Mumps and Rubella

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Experimental: Treatment Group C; MV-CHIK high

    60 subjects will receive i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: MV-CHIK high dose
    recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
    Other Names:
  • vaccine against Chikungunya

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Experimental: Treatment Group D; MV-CHIK high

    60 subjects will receive i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: MV-CHIK high dose
    recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
    Other Names:
  • vaccine against Chikungunya

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Experimental: Measles Booster Group 1

    20 subjects will receive i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: MV-CHIK low dose
    recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
    Other Names:
  • vaccine against Chikungunya

    • Biological: Priorix®
    lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
    Other Names:
  • vaccine against Measles, Mumps and Rubella

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•
    Experimental: Measles Booster Group 2

    20 subjects will receive i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits.

    Biological: MV-CHIK low dose
    recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
    Other Names:
  • vaccine against Chikungunya

    • Biological: Priorix®
    lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
    Other Names:
  • vaccine against Measles, Mumps and Rubella

    • Biological: physiological saline solution
    sterile physiological saline solution 0.9% used as placebo
    Other Names:
  • 0.9% sodium chloride (NaCl)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) [Study day 56 (28 days after one or two vaccinations depending on treatment group).]

      Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.

    Secondary Outcome Measures

    1. Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) [Baseline until study day 224]

      Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50).

    2. Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay [Baseline until study day 56]

      Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA).

    3. Number of Participants With Solicited Local and Systemic Adverse Events [Solicited adverse events were recorded for 7 days after each vaccination]

      Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

    4. Number of Participants Who Experienced Treatment Emergent Adverse Events [First vaccination until study day 224]

      Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

    5. Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 [Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196]

      Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR).

    6. Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 [Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196]

      Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR).

    7. Chikungunya Virus Specific T Cell Responses [Baseline until study day 224]

      Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis.

    8. Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) [Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224]

      Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA).

    9. Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer [Study day 56 (28 days after one or two vaccinations depending on treatment group)]

      To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Signed informed consent obtained before any trial-related activities.

    2. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study

    3. Available for the duration of the trial

    4. Healthy men or women aged >18 and <55 years

    5. In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception as specified in protocol

    6. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant

    7. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)

    Exclusion Criteria:

    1. Participation in another clinical study within the past month in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period

    2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection, current hepatitis B/C infection,

    3. Drug addiction including alcohol dependence

    4. Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination (not more than 20g alcohol per day, which equals 0.5 L beer or 0.25 L of wine)

    5. Persons who are accommodated in an institution on court or official order.

    6. Persons in direct relationship with the sponsor, an Investigator or other study site staff. Direct relationship includes relatives or close dependents (children, spouse/partner, siblings or parents), as well as employees (site or sponsor).

    7. Non-study licensed vaccines: vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine during the study period.

    8. Measles vaccination or booster within the last 5 years or during the clinical study

    9. Prior receipt of any Chikungunya vaccine

    10. Blood donations during 1 month prior to Screening Visit and throughout the study

    11. Recent infection (within 1 week prior to Screening Visit) (If non-serious, can be basis for temporary deferral)

    12. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study

    13. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy.

    14. History of autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease).

    15. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit.

    16. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.

    17. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine.

    18. History of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the volunteers

    19. Clinically relevant abnormal laboratory values indicative of physical illness

    • Hematology: hemoglobin, hematocrit, erythrocyte count, differential white blood count, platelets

    • Chemistry: creatinine (≥1.7 mg/dL), potassium, sodium, calcium, aspartate transaminase/alanine aminotransferase (AST/ALT) ≥ 2.6 upper limit of normal (ULN), alkaline phosphatase, bilirubin

    • Coagulation parameter: prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen according to the evaluation of the principle investigator

    • Urinalysis according to the evaluation of the principle investigator

    1. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers may affect the validity of the study except hormonal contraception in female subjects; prior to taking any medication during 72 h prior to the first vaccination, the study center should be consulted.

    2. Immunosuppressive drugs: use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination, or anticipated use during the trial.

    3. Receipt of blood products or immunoglobulins within 120 days prior to Screening Visit or anticipated receipt of any blood products or immunoglobulin during the trial.

    4. Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential (for details please refer to section 8.3.6)

    5. Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion

    6. Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.

    7. Inability or unwillingness to provide informed consent and to abide by the requirements of the study

    8. Refusal to allow storage of specimens for future research.

    9. Regular blood plasma donations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hansa Sanatorium GmbH Graz Austria 8010
    2 Medical University Vienna, Department of Clinical Pharmacology Vienna Austria 1090
    3 Berliner Center for Travel- and Tropical Medicine Berlin Germany 10117
    4 Medicinal University Rostock, Department for Tropical Medicin and infectious diseases Rostock Germany 18057

    Sponsors and Collaborators

    • Themis Bioscience GmbH

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Themis Bioscience GmbH
    ClinicalTrials.gov Identifier:
    NCT02861586
    Other Study ID Numbers:
    • MV-CHIK-202
    • 2015-004037-26
    • V184-002
    First Posted:
    Aug 10, 2016
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Themis Bioscience GmbH
    Chikungunya, infectious disease
    Additional relevant MeSH terms:
    Chikungunya Fever
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details 322 participants screened for eligibility, 263 participants randomized
    Pre-assignment Detail 59 screening failures (33 withdrawal of consent, 26 violation of in-/exclusion criteria)
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Period Title: Overall Study
    STARTED 51 18 47 16 47 50 18 16
    COMPLETED 47 15 46 16 47 45 17 16
    NOT COMPLETED 4 3 1 0 0 5 1 0

    Baseline Characteristics

    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2 Total
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Total of all reporting groups
    Overall Participants 51 18 47 16 47 50 18 16 263
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    31.4
    (10.13)
    32.2
    (10.01)
    32.7
    (10.53)
    33.6
    (11.56)
    35.1
    (12.32)
    31.2
    (9.93)
    31.1
    (10.41)
    32.6
    (10.28)
    32.5
    (10.65)
    Sex: Female, Male (Count of Participants)
    Female
    27
    52.9%
    10
    55.6%
    29
    61.7%
    7
    43.8%
    24
    51.1%
    27
    54%
    11
    61.1%
    5
    31.3%
    140
    53.2%
    Male
    24
    47.1%
    8
    44.4%
    18
    38.3%
    9
    56.3%
    23
    48.9%
    23
    46%
    7
    38.9%
    11
    68.8%
    123
    46.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    5.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2.1%
    1
    2%
    0
    0%
    0
    0%
    2
    0.8%
    White
    50
    98%
    17
    94.4%
    47
    100%
    16
    100%
    45
    95.7%
    49
    98%
    17
    94.4%
    16
    100%
    257
    97.7%
    More than one race
    1
    2%
    0
    0%
    0
    0%
    0
    0%
    1
    2.1%
    0
    0%
    1
    5.6%
    0
    0%
    3
    1.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
    Description Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.
    Time Frame Study day 56 (28 days after one or two vaccinations depending on treatment group).

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 49 16 44 2 47 44 16 15
    Geometric Mean (Standard Deviation) [Titer]
    50.2
    (127.69)
    5.0
    (0.00)
    12.9
    (100.47)
    5.0
    (0.00)
    174.8
    (436.11)
    33.6
    (59.38)
    80.0
    (233.80)
    5.0
    (0.00)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group B; MV-CHIK Low
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 3.9
    Confidence Interval (2-Sided) 95%
    2.0 to 7.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group C; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    0.1 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group D; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6334
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    0.8 to 3.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Measles Booster Group 1
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8065
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    0.2 to 1.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 10.0
    Confidence Interval (2-Sided) 95%
    3.8 to 26.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group A/C; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.0 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group B/D; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.0 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group C; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.0 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group D; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    0.2 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Measles Booster Group 1
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    0.1 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0718
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 2.6
    Confidence Interval (2-Sided) 95%
    1.0 to 6.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group B; MV-CHIK Low
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0593
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    0.1 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group B/D; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0593
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Gemetric mean ratio
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    0.1 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Treatment Group C; MV-CHIK High, Treatment Group D; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 5.2
    Confidence Interval (2-Sided) 95%
    2.6 to 10.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Treatment Group C; MV-CHIK High, Measles Booster Group 1
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2005
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 2.2
    Confidence Interval (2-Sided) 95%
    0.8 to 5.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Treatment Group C; MV-CHIK High, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 35.0
    Confidence Interval (2-Sided) 95%
    13.1 to 93.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group C; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    0.0 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Treatment Group C; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.0
    Confidence Interval (2-Sided) 0.0%
    0.0 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Treatment Group D; MV-CHIK High, Measles Booster Group 1
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1138
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    0.2 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Treatment Group D; MV-CHIK High, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 6.7
    Confidence Interval (2-Sided) 95%
    2.5 to 18.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group D; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.1 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Treatment Group D; MV-CHIK High
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.1 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Measles Booster Group 1, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 16.0
    Confidence Interval (2-Sided) 95%
    4.9 to 52.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Measles Booster Group 1
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.0 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Measles Booster Group 1
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    0.0 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    0.3 to 3.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Measles Booster Group 2
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    0.3 to 3.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group B/D; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.
    Method ANOVA
    Comments Analysis of variance was conducted with treatment group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    0.3 to 3.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
    Description Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50).
    Time Frame Baseline until study day 224

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 49 16 44 16 47 44 16 15
    Visit 1 /day 0
    5.1
    (0.71)
    5.0
    (0.00)
    5.3
    (3.16)
    5.0
    (0.00)
    5.0
    (0.00)
    5.0
    (0.00)
    5.0
    (0.00)
    5.0
    (0.00)
    Visit 2 /day 28
    11.2
    (63.40)
    5.0
    (0.00)
    5.5
    (3.82)
    5.0
    (0.00)
    25.7
    (52.22)
    5.1
    (0.75)
    13.5
    (40.52)
    5.0
    (0.00)
    Visit 4 /day 168
    28.9
    (52.25)
    5.0
    (0.00)
    Visit 5 /day 196
    13.5
    (33.46)
    5.0
    (0.00)
    6.4
    (8.29)
    5.00
    (0.00)
    38.8
    (70.59)
    16.5
    (81.75)
    24.1
    (106.25)
    11.5
    (26.04)
    Visit 6 /day 224
    14.6
    (37.87)
    5.0
    (0.00)
    70.5
    (174.57)
    5.0
    (0.00)
    41.8
    (105.55)
    609.8
    (949.70)
    18.3
    (87.50)
    66.5
    (172.62)
    3. Secondary Outcome
    Title Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay
    Description Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA).
    Time Frame Baseline until study day 56

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 49 16 44 16 47 44 16 15
    Visit 0 / day -28
    542.6
    (1118.52)
    304.5
    (343.53)
    Visit 1 / day 0
    456.2
    (1398.54)
    693.9
    (1307.42)
    398.1
    (1267.55)
    390.4
    (1106.86)
    495.0
    (1181.36)
    401.8
    (1073.54)
    785.6
    (1149.47)
    645.9
    (850.56)
    Visit 2 / day 28
    1509.4
    (1360.83)
    1200.6
    (1129.77)
    396.9
    (1183.04)
    447.5
    (1139.37)
    2343.9
    (1357.29)
    492.1
    (1227.24)
    1761.5
    (1578.85)
    561.2
    (385.36)
    Visit 3 / day 56
    1651.8
    (1384.39)
    1129.4
    (1168.63)
    1255.0
    (1279.28)
    673.8
    (917.52)
    2750.5
    (1284.23)
    2435.2
    (1461.78)
    1825.2
    (1459.93)
    521.4
    (455.37)
    4. Secondary Outcome
    Title Number of Participants With Solicited Local and Systemic Adverse Events
    Description Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
    Time Frame Solicited adverse events were recorded for 7 days after each vaccination

    Outcome Measure Data

    Analysis Population Description
    All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 51 18 47 16 47 50 18 16
    Count of Participants [Participants]
    35
    68.6%
    14
    77.8%
    32
    68.1%
    10
    62.5%
    37
    78.7%
    41
    82%
    13
    72.2%
    10
    62.5%
    5. Secondary Outcome
    Title Number of Participants Who Experienced Treatment Emergent Adverse Events
    Description Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
    Time Frame First vaccination until study day 224

    Outcome Measure Data

    Analysis Population Description
    All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 51 18 47 16 47 50 18 16
    TEAEs
    29
    56.9%
    10
    55.6%
    27
    57.4%
    7
    43.8%
    22
    46.8%
    18
    36%
    11
    61.1%
    9
    56.3%
    Serious TEAEs
    1
    2%
    1
    5.6%
    2
    4.3%
    1
    6.3%
    0
    0%
    1
    2%
    0
    0%
    0
    0%
    Severe TEAEs
    1
    2%
    1
    5.6%
    2
    4.3%
    0
    0%
    0
    0%
    2
    4%
    1
    5.6%
    1
    6.3%
    Related TEAEs
    8
    15.7%
    2
    11.1%
    11
    23.4%
    1
    6.3%
    4
    8.5%
    10
    20%
    4
    22.2%
    5
    31.3%
    Medically attended TEAEs
    12
    23.5%
    3
    16.7%
    15
    31.9%
    1
    6.3%
    9
    19.1%
    8
    16%
    4
    22.2%
    3
    18.8%
    TEAEs where an action was taken
    0
    0%
    0
    0%
    1
    2.1%
    1
    6.3%
    0
    0%
    1
    2%
    0
    0%
    0
    0%
    TEAEs of special interest
    2
    3.9%
    0
    0%
    2
    4.3%
    0
    0%
    0
    0%
    1
    2%
    2
    11.1%
    0
    0%
    6. Secondary Outcome
    Title Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196
    Description Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR).
    Time Frame Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196

    Outcome Measure Data

    Analysis Population Description
    As subjects of the measles booster groups M1 and M2 received a measles vaccination prior to the modified MV-CHIK vaccine, these groups had to be excluded from measles shedding analysis.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 8 4 4 2 8 5 0 0
    Visit 1 /day 0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    day 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    day 10
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    day 14
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Visit 2 /day 28
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Visit 5 /day 196
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196
    Description Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR).
    Time Frame Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196

    Outcome Measure Data

    Analysis Population Description
    As subjects of the measles booster groups M1 and M2 received a measles vaccination prior to the modified MV-CHIK vaccine, these groups had to be excluded from measles shedding analysis.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 8 4 4 2 8 5 0 0
    Visit 1/Day 0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 10
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 14
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Visit 2/Day 28
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Visit 5/Day 196
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8. Secondary Outcome
    Title Chikungunya Virus Specific T Cell Responses
    Description Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis.
    Time Frame Baseline until study day 224

    Outcome Measure Data

    Analysis Population Description
    A subset of the mITT Population was analyzed for T-cell Response.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 51 18 47 16 47 50 18 16
    Visit 1 /day 0
    0.0
    (0.00)
    0.0
    (0.00)
    12.1
    (40.10)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    Visit 2 /day 28
    41.5
    (128.71)
    0.0
    (0.00)
    10.5
    (39.29)
    Visit 3 /day 56
    46.5
    (63.54)
    0.0
    (0.00)
    36.7
    (68.41)
    25.2
    (56.35)
    53.4
    (74.38)
    6.5
    (21.41)
    47.0
    (51.55)
    0.0
    (0.00)
    Visit 6 /day 224
    28.3
    (48.92)
    0.0
    (0.00)
    71.8
    (133.03)
    13.2
    (29.52)
    11.6
    (23.06)
    30.1
    (61.48)
    0.0
    (0.00)
    0.0
    (0.00)
    9. Secondary Outcome
    Title Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA)
    Description Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA).
    Time Frame Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    Measure Participants 49 16 44 16 47 44 16 15
    Visit 1 /day 0
    2.1
    (1.94)
    3.6
    (3.64)
    2.3
    (1.68)
    1.7
    (1.05)
    2.3
    (2.75)
    2.2
    (1.53)
    2.4
    (2.69)
    2.2
    (2.25)
    Visit 2 /day 28
    3.2
    (6.57)
    3.4
    (3.13)
    2.2
    (1.81)
    2.0
    (2.75)
    6.2
    (4.65)
    2.5
    (1.74)
    4.3
    (9.48)
    2.0
    (2.37)
    Visit 3 /day 56
    13.6
    (31.84)
    3.4
    (4.06)
    3.4
    (6.26)
    1.7
    (1.63)
    74.4
    (41.45)
    6.6
    (18.68)
    28.0
    (47.51)
    2.3
    (2.10)
    Visit 4 /day 168
    9.5
    (29.82)
    1.8
    (2.28)
    Visit 5 /day 196
    5.6
    (16.04)
    3.3
    (4.02)
    3.0
    (3.11)
    1.9
    (2.06)
    15.2
    (25.08)
    5.6
    (21.33)
    8.9
    (24.13)
    3.6
    (5.48)
    Visit 6 /day 224
    4.6
    (9.46)
    3.1
    (4.66)
    25.4
    (52.43)
    1.7
    (1.82)
    13.1
    (24.24)
    130.8
    (43.94)
    7.3
    (28.56)
    20.4
    (43.19)
    10. Secondary Outcome
    Title Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer
    Description To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups.
    Time Frame Study day 56 (28 days after one or two vaccinations depending on treatment group)

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation.
    Arm/Group Title Baseline Measles Titer Percentile 0 to 25% Baseline Measles Titer Percentile 25 to 50% Baseline Measles Titer Percentile 50 to 75% Baseline Measles Titer Percentile 75 to 100%
    Arm/Group Description Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value. Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value. Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value. Participants in Treatment Groups A, B, C, and D categorized according to baseline measles titer value.
    Measure Participants 45 48 45 46
    Geometric Mean (Standard Deviation) [Titer]
    155.1
    (532.68)
    177.0
    (897.74)
    117.6
    (346.86)
    100.8
    (535.78)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group A/C; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9775
    Comments
    Method ANOVA
    Comments Analysis of variance was performed with baseline measles titer group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    0.4 to 2.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group B; MV-CHIK Low
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8366
    Comments
    Method ANOVA
    Comments Analysis of variance was performed with baseline measles titer group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    0.6 to 3.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group B/D; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5625
    Comments
    Method ANOVA
    Comments Analysis of variance was performed with baseline measles titer group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    0.7 to 3.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group B; MV-CHIK Low
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5924
    Comments
    Method ANOVA
    Comments Analysis of variance was performed with baseline measles titer group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    0.6 to 3.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group B/D; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3122
    Comments
    Method ANOVA
    Comments Analysis of variance was performed with baseline measles titer group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.8
    Confidence Interval (2-Sided) 95%
    0.8 to 4.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group B/D; Priorix®
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9665
    Comments
    Method ANOVA
    Comments Analysis of variance was performed with baseline measles titer group as a fixed factor.
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    0.5 to 2.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit.
    Adverse Event Reporting Description Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
    Arm/Group Title Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Arm/Group Description Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
    All Cause Mortality
    Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/51 (0%) 0/18 (0%) 0/47 (0%) 0/16 (0%) 0/47 (0%) 0/50 (0%) 0/18 (0%) 0/16 (0%)
    Serious Adverse Events
    Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/51 (2%) 1/18 (5.6%) 2/47 (4.3%) 1/16 (6.3%) 0/47 (0%) 1/50 (2%) 0/18 (0%) 0/16 (0%)
    Gastrointestinal disorders
    umbilical hernia 1/51 (2%) 1 0/18 (0%) 1 0/47 (0%) 1 0/16 (0%) 1 0/47 (0%) 1 0/50 (0%) 1 0/18 (0%) 1 0/16 (0%) 1
    Injury, poisoning and procedural complications
    ligament rupture 0/51 (0%) 0/18 (0%) 1/47 (2.1%) 1 0/16 (0%) 1 0/47 (0%) 1 0/50 (0%) 1 0/18 (0%) 1 0/16 (0%) 1
    Metabolism and nutrition disorders
    type 2 diabetes mellitus 0/51 (0%) 0/18 (0%) 0/47 (0%) 1/16 (6.3%) 1 0/47 (0%) 1 0/50 (0%) 1 0/18 (0%) 1 0/16 (0%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    papillary thyroid cancer 0/51 (0%) 0/18 (0%) 0/47 (0%) 0/16 (0%) 0/47 (0%) 1/50 (2%) 1 0/18 (0%) 1 0/16 (0%) 1
    laryngeal cancer 0/51 (0%) 1/18 (5.6%) 1 0/47 (0%) 1 0/16 (0%) 1 0/47 (0%) 1 0/50 (0%) 1 0/18 (0%) 1 0/16 (0%) 1
    Pregnancy, puerperium and perinatal conditions
    abortion 0/51 (0%) 0/18 (0%) 1/47 (2.1%) 1 0/16 (0%) 1 0/47 (0%) 1 0/50 (0%) 1 0/18 (0%) 1 0/16 (0%) 1
    Other (Not Including Serious) Adverse Events
    Treatment Group A; MV-CHIK Low Treatment Group A/C; Priorix® Treatment Group B; MV-CHIK Low Treatment Group B/D; Priorix® Treatment Group C; MV-CHIK High Treatment Group D; MV-CHIK High Measles Booster Group 1 Measles Booster Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/51 (78.4%) 14/18 (77.8%) 36/47 (76.6%) 11/16 (68.8%) 38/47 (80.9%) 41/50 (82%) 15/18 (83.3%) 14/16 (87.5%)
    Blood and lymphatic system disorders
    Lymphadenopathy 2/51 (3.9%) 2 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 1/47 (2.1%) 1 0/50 (0%) 0 1/18 (5.6%) 3 0/16 (0%) 0
    Vertigo 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 2/16 (12.5%) 2
    Eye disorders
    Dry eye 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Eye pruritus 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Gastrointestinal disorders
    Abdominal pain upper 3/51 (5.9%) 3 0/18 (0%) 0 0/47 (0%) 0 1/16 (6.3%) 1 2/47 (4.3%) 2 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Diarrhoea 1/51 (2%) 1 1/18 (5.6%) 1 1/47 (2.1%) 1 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 1 1/18 (5.6%) 1 0/16 (0%) 0
    Abdominal pain 1/51 (2%) 1 1/18 (5.6%) 1 1/47 (2.1%) 1 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 2
    Toothache 1/51 (2%) 1 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 1 0/18 (0%) 0 1/16 (6.3%) 1
    Nausea 8/51 (15.7%) 10 4/18 (22.2%) 7 2/47 (4.3%) 3 2/16 (12.5%) 2 2/47 (4.3%) 2 6/50 (12%) 7 2/18 (11.1%) 2 1/16 (6.3%) 3
    Vomiting 0/51 (0%) 0 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 1/47 (2.1%) 1 1/50 (2%) 1 0/18 (0%) 0 0/16 (0%) 0
    General disorders
    Influenza like illness 13/51 (25.5%) 17 4/18 (22.2%) 4 9/47 (19.1%) 12 1/16 (6.3%) 1 9/47 (19.1%) 12 8/50 (16%) 16 2/18 (11.1%) 2 4/16 (25%) 7
    Fatigue 10/51 (19.6%) 15 5/18 (27.8%) 9 9/47 (19.1%) 20 3/16 (18.8%) 5 13/47 (27.7%) 19 14/50 (28%) 25 5/18 (27.8%) 10 4/16 (25%) 9
    Axillary pain 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Injection site erythema 6/51 (11.8%) 8 2/18 (11.1%) 3 5/47 (10.6%) 6 2/16 (12.5%) 2 10/47 (21.3%) 18 9/50 (18%) 11 2/18 (11.1%) 4 2/16 (12.5%) 2
    Injection site induration 5/51 (9.8%) 7 0/18 (0%) 0 6/47 (12.8%) 6 0/16 (0%) 0 8/47 (17%) 12 15/50 (30%) 24 2/18 (11.1%) 2 1/16 (6.3%) 1
    Injection site oedema 4/51 (7.8%) 8 0/18 (0%) 0 2/47 (4.3%) 2 0/16 (0%) 0 3/47 (6.4%) 4 4/50 (8%) 6 1/18 (5.6%) 2 1/16 (6.3%) 1
    Injection site pain 24/51 (47.1%) 51 6/18 (33.3%) 12 21/47 (44.7%) 37 5/16 (31.3%) 7 30/47 (63.8%) 71 39/50 (78%) 119 8/18 (44.4%) 29 7/16 (43.8%) 18
    Injection site pruritus 0/51 (0%) 0 0/18 (0%) 0 1/47 (2.1%) 1 0/16 (0%) 0 2/47 (4.3%) 4 3/50 (6%) 4 0/18 (0%) 0 2/16 (12.5%) 2
    Pyrexia 3/51 (5.9%) 3 1/18 (5.6%) 1 1/47 (2.1%) 1 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Immune system disorders
    Seasonal allergy 0/51 (0%) 0 0/18 (0%) 0 1/47 (2.1%) 1 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 2 1/18 (5.6%) 1 0/16 (0%) 0
    Infections and infestations
    Nasopharyngitis 7/51 (13.7%) 7 2/18 (11.1%) 2 4/47 (8.5%) 4 2/16 (12.5%) 3 4/47 (8.5%) 5 4/50 (8%) 5 2/18 (11.1%) 5 1/16 (6.3%) 1
    Rhinitis 2/51 (3.9%) 2 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 3/47 (6.4%) 3 2/50 (4%) 2 2/18 (11.1%) 3 2/16 (12.5%) 2
    Upper respiratory tract infection 3/51 (5.9%) 3 1/18 (5.6%) 1 3/47 (6.4%) 4 0/16 (0%) 0 1/47 (2.1%) 2 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Urinary tract infection 1/51 (2%) 1 1/18 (5.6%) 1 1/47 (2.1%) 1 0/16 (0%) 0 1/47 (2.1%) 1 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Gingivitis 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Hordeolum 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Respiratory tract infection 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Vaginal infection 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Vulvovaginal candidiasis 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Cystitis 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 1 0/18 (0%) 0 1/16 (6.3%) 1
    Gastroenteritis 0/51 (0%) 0 0/18 (0%) 0 2/47 (4.3%) 2 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Otitis externa 1/51 (2%) 1 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Tonsillitis 0/51 (0%) 0 0/18 (0%) 0 1/47 (2.1%) 1 0/16 (0%) 0 1/47 (2.1%) 1 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Injury, poisoning and procedural complications
    Injury 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 1/16 (6.3%) 1 1/47 (2.1%) 1 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Skin abrasion 0/51 (0%) 0 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 1 0/18 (0%) 0 0/16 (0%) 0
    Contusion 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Metabolism and nutrition disorders
    Appetite disorder 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 2/51 (3.9%) 2 0/18 (0%) 0 2/47 (4.3%) 2 1/16 (6.3%) 1 2/47 (4.3%) 3 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Myalgia 9/51 (17.6%) 12 5/18 (27.8%) 8 6/47 (12.8%) 9 2/16 (12.5%) 2 5/47 (10.6%) 7 13/50 (26%) 22 4/18 (22.2%) 8 1/16 (6.3%) 2
    Musculoskeletal pain 0/51 (0%) 0 1/18 (5.6%) 1 1/47 (2.1%) 1 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Bursitis 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Muscle spasms 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0
    Arthralgia 8/51 (15.7%) 9 3/18 (16.7%) 3 5/47 (10.6%) 7 2/16 (12.5%) 2 2/47 (4.3%) 2 7/50 (14%) 11 2/18 (11.1%) 3 3/16 (18.8%) 3
    Arthritis reactive 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 1/16 (6.3%) 1 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Intervertabral disc protrusion 0/51 (0%) 0 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 1/47 (2.1%) 2 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Limb Discomfort 7/51 (13.7%) 7 3/18 (16.7%) 3 5/47 (10.6%) 7 2/16 (12.5%) 2 4/47 (8.5%) 4 11/50 (22%) 19 1/18 (5.6%) 1 1/16 (6.3%) 1
    Nervous system disorders
    Headache 20/51 (39.2%) 36 10/18 (55.6%) 19 16/47 (34%) 32 6/16 (37.5%) 13 14/47 (29.8%) 30 17/50 (34%) 47 9/18 (50%) 18 8/16 (50%) 19
    Renal and urinary disorders
    Hypertonic bladder 0/51 (0%) 0 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Reproductive system and breast disorders
    Dysmenorrhoea 1/51 (2%) 2 0/18 (0%) 0 1/47 (2.1%) 3 0/16 (0%) 0 1/47 (2.1%) 2 2/50 (4%) 8 2/18 (11.1%) 4 1/16 (6.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 1/51 (2%) 1 1/18 (5.6%) 1 1/47 (2.1%) 1 1/16 (6.3%) 1 4/47 (8.5%) 5 1/50 (2%) 1 2/18 (11.1%) 3 1/16 (6.3%) 1
    Cough 1/51 (2%) 1 1/18 (5.6%) 1 2/47 (4.3%) 2 0/16 (0%) 0 1/47 (2.1%) 1 0/50 (0%) 0 1/18 (5.6%) 1 1/16 (6.3%) 1
    Dysphonia 0/51 (0%) 0 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 1/47 (2.1%) 1 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Sneezing 0/51 (0%) 0 1/18 (5.6%) 1 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 0/16 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact 1/51 (2%) 1 1/18 (5.6%) 2 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 1 0/18 (0%) 0 0/16 (0%) 0
    Erythema multiforme 0/51 (0%) 0 0/18 (0%) 0 0/47 (0%) 0 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 0/18 (0%) 0 1/16 (6.3%) 1
    Rash 0/51 (0%) 0 2/18 (11.1%) 2 3/47 (6.4%) 3 0/16 (0%) 0 0/47 (0%) 0 1/50 (2%) 8 1/18 (5.6%) 1 0/16 (0%) 0
    Vascular disorders
    Haematoma 0/51 (0%) 0 0/18 (0%) 0 1/47 (2.1%) 1 0/16 (0%) 0 0/47 (0%) 0 0/50 (0%) 0 1/18 (5.6%) 1 0/16 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Themis Bioscience GmbH
    ClinicalTrials.gov Identifier:
    NCT02861586
    Other Study ID Numbers:
    • MV-CHIK-202
    • 2015-004037-26
    • V184-002
    First Posted:
    Aug 10, 2016
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021