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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004037-26 | EudraCT Number | ||
| V184-002 | Other Identifier | Merck & Co., protocol ID since aquisition in May 2020 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A; MV-CHIK low | Experimental | 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. |
|
| Treatment Group A/C; Priorix® | Active Comparator | 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. |
|
| Treatment Group B; MV-CHIK low | Experimental | 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. |
|
| Treatment Group B/D; Priorix® | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MV-CHIK low dose | Biological | recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 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. | Study day 56 (28 days after one or two vaccinations depending on treatment group). |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 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). | Baseline until study day 224 |
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Inclusion Criteria:
Exclusion Criteria:
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
History of immunodeficiency, known human immunodeficiency virus (HIV) infection, current hepatitis B/C infection,
Drug addiction including alcohol dependence
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)
Persons who are accommodated in an institution on court or official order.
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).
Non-study licensed vaccines: vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine during the study period.
Measles vaccination or booster within the last 5 years or during the clinical study
Prior receipt of any Chikungunya vaccine
Blood donations during 1 month prior to Screening Visit and throughout the study
Recent infection (within 1 week prior to Screening Visit) (If non-serious, can be basis for temporary deferral)
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
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.
History of autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease).
History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit.
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.
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.
History of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the volunteers
Clinically relevant abnormal laboratory values indicative of physical illness
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.
Immunosuppressive drugs: use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination, or anticipated use during the trial.
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.
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)
Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.
Inability or unwillingness to provide informed consent and to abide by the requirements of the study
Refusal to allow storage of specimens for future research.
Regular blood plasma donations
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hansa Sanatorium GmbH | Graz | 8010 | Austria | |||
| Medical University Vienna, Department of Clinical Pharmacology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25739878 | Background | Ramsauer K, Schwameis M, Firbas C, Mullner M, Putnak RJ, Thomas SJ, Despres P, Tauber E, Jilma B, Tangy F. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2. | |
| 34582377 |
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59 screening failures (33 withdrawal of consent, 26 violation of in-/exclusion criteria)
322 participants screened for eligibility, 263 participants randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group A; MV-CHIK Low | 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 |
| FG001 | Treatment Group A/C; Priorix® | 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 |
| FG002 | Treatment Group B; MV-CHIK Low | 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 |
| FG003 | Treatment Group B/D; Priorix® | 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 |
| FG004 | Treatment Group C; MV-CHIK High | 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 |
| FG005 | Treatment Group D; MV-CHIK High | 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 |
| FG006 | Measles Booster Group 1 | 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 |
| FG007 | Measles Booster Group 2 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Population as well as the Modified Intent-to-treat (mITT) population included all randomized subjects who received at least one vaccination and included 263 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group A; MV-CHIK Low | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demography and baseline characteristics include 263 participants of the mITT population |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 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. | The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation | Posted | Geometric Mean | Standard Deviation | Titer | Study day 56 (28 days after one or two vaccinations depending on treatment group). |
|
32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group A; MV-CHIK Low | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| umbilical hernia | Gastrointestinal disorders | umbilical hernia | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2017 | Mar 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2018 | Mar 1, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Treatment Group C; MV-CHIK high | Experimental | 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. |
|
| Treatment Group D; MV-CHIK high | Experimental | 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. |
|
| Measles Booster Group 1 | Experimental | 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. |
|
| Measles Booster Group 2 | Experimental | 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. |
|
|
| MV-CHIK high dose | Biological | recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose |
|
|
| Priorix® | Biological | 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 | Biological | sterile physiological saline solution 0.9% used as placebo |
|
|
| Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | 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). | Baseline until study day 56 |
| Number of Participants With Solicited Local and Systemic Adverse Events | 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. | Solicited adverse events were recorded for 7 days after each vaccination |
| Number of Participants Who Experienced Treatment Emergent Adverse Events | 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. | First vaccination until study day 224 |
| Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 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). | Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196 |
| Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 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). | Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196 |
| Chikungunya Virus Specific T Cell Responses | 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. | Baseline until study day 224 |
| Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | 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). | Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224 |
| Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | 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. | Study day 56 (28 days after one or two vaccinations depending on treatment group) |
| Vienna |
| 1090 |
| Austria |
| Berliner Center for Travel- and Tropical Medicine | Berlin | 10117 | Germany |
| Medicinal University Rostock, Department for Tropical Medicin and infectious diseases | Rostock | 18057 | Germany |
| Derived |
| Tschismarov R, Zellweger RM, Koh MJ, Leong YS, Low JG, Ooi EE, Mandl CW, Ramsauer K, de Alwis R. Antibody effector analysis of prime versus prime-boost immunizations with a recombinant measles-vectored chikungunya virus vaccine. JCI Insight. 2021 Nov 8;6(21):e151095. doi: 10.1172/jci.insight.151095. |
| 30409443 | Derived | Reisinger EC, Tschismarov R, Beubler E, Wiedermann U, Firbas C, Loebermann M, Pfeiffer A, Muellner M, Tauber E, Ramsauer K. Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial. Lancet. 2019 Dec 22;392(10165):2718-2727. doi: 10.1016/S0140-6736(18)32488-7. Epub 2018 Nov 5. |
| Lost to Follow-up |
|
| Adverse Event |
|
| BG001 | Treatment Group A/C; Priorix® | 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 |
| BG002 | Treatment Group B; MV-CHIK Low | 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 |
| BG003 | Treatment Group B/D; Priorix® | 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 |
| BG004 | Treatment Group C; MV-CHIK High | 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 |
| BG005 | Treatment Group D; MV-CHIK High | 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 |
| BG006 | Measles Booster Group 1 | 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 |
| BG007 | Measles Booster Group 2 | 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 |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Demography and baseline characterisitcs of mITT Population including 263 subjects. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Demography and baseline characteristics including mITT Population of 263 participants | Count of Participants | Participants |
|
| OG001 | Treatment Group A/C; Priorix® | 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 |
| OG002 | Treatment Group B; MV-CHIK Low | 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 |
| OG003 | Treatment Group B/D; Priorix® | 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 |
| OG004 | Treatment Group C; MV-CHIK High | 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 |
| OG005 | Treatment Group D; MV-CHIK High | 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 |
| OG006 | Measles Booster Group 1 | 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 |
| OG007 | Measles Booster Group 2 | 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 |
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|
|
| Secondary | Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) | 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). | The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation. | Posted | Geometric Mean | Standard Deviation | Titer | Baseline until study day 224 |
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|
|
| Secondary | Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay | 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). | The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation | Posted | Geometric Mean | Standard Deviation | Titer | Baseline until study day 56 |
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|
|
| Secondary | Number of Participants With Solicited Local and Systemic Adverse Events | 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. | All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination. | Posted | Count of Participants | Participants | Solicited adverse events were recorded for 7 days after each vaccination |
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|
|
| Secondary | Number of Participants Who Experienced Treatment Emergent Adverse Events | 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. | All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination. | Posted | Count of Participants | Participants | First vaccination until study day 224 |
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|
| Secondary | Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 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). | 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. | Posted | Count of Participants | Participants | Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196 |
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|
|
| Secondary | Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 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). | 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. | Posted | Count of Participants | Participants | Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196 |
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| Secondary | Chikungunya Virus Specific T Cell Responses | 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. | A subset of the mITT Population was analyzed for T-cell Response. | Posted | Mean | Standard Deviation | Titer | Baseline until study day 224 |
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| Secondary | Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) | 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). | The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation. | Posted | Geometric Mean | Standard Deviation | Titer | Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224 |
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| Secondary | Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer | 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. | The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation. | Posted | Geometric Mean | Standard Deviation | Titer | Study day 56 (28 days after one or two vaccinations depending on treatment group) |
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|
|
|
| 0 |
| 51 |
| 1 |
| 51 |
| 40 |
| 51 |
| EG001 | Treatment Group A/C; Priorix® | 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 | 0 | 18 | 1 | 18 | 14 | 18 |
| EG002 | Treatment Group B; MV-CHIK Low | 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 | 0 | 47 | 2 | 47 | 36 | 47 |
| EG003 | Treatment Group B/D; Priorix® | 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 | 0 | 16 | 1 | 16 | 11 | 16 |
| EG004 | Treatment Group C; MV-CHIK High | 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 | 0 | 47 | 0 | 47 | 38 | 47 |
| EG005 | Treatment Group D; MV-CHIK High | 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 | 0 | 50 | 1 | 50 | 41 | 50 |
| EG006 | Measles Booster Group 1 | 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 | 0 | 18 | 0 | 18 | 15 | 18 |
| EG007 | Measles Booster Group 2 | 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 | 0 | 16 | 0 | 16 | 14 | 16 |
| ligament rupture | Injury, poisoning and procedural complications | ligament rupture | Non-systematic Assessment | rupture cruciate ligament left knee |
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| abortion | Pregnancy, puerperium and perinatal conditions | abortion | Systematic Assessment | suspected abortion |
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| papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | papillary thyroid ca | Non-systematic Assessment | papillary thyroid carcinoma |
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| laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | laryngeal cancer | Non-systematic Assessment | larynx carcinoma |
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| type 2 diabetes mellitus | Metabolism and nutrition disorders | type 2 diabetes mell | Systematic Assessment | diabetes mellitus type 2 |
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| Seasonal allergy | Immune system disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Axillary pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Appetite disorder | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Intervertabral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
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| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
Not provided
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Visit 2 /day 28 |
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| Visit 4 /day 168 |
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| Visit 5 /day 196 |
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| Visit 6 /day 224 |
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| Visit 1 / day 0 |
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| Visit 2 / day 28 |
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| Visit 3 / day 56 |
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| Serious TEAEs |
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| Severe TEAEs |
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| Related TEAEs |
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| Medically attended TEAEs |
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| TEAEs where an action was taken |
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| TEAEs of special interest |
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| day 7 |
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| day 10 |
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| day 14 |
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| Visit 2 /day 28 |
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| Visit 5 /day 196 |
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| Day 7 |
|
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| Day 10 |
|
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| Day 14 |
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| Visit 2/Day 28 |
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| Visit 5/Day 196 |
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| Visit 2 /day 28 |
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| Visit 3 /day 56 |
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| Visit 6 /day 224 |
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| Visit 2 /day 28 |
|
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| Visit 3 /day 56 |
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| Visit 4 /day 168 |
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| Visit 5 /day 196 |
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| Visit 6 /day 224 |
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|
Analysis of variance was performed with baseline measles titer group as a fixed factor.
| 0.8366 |
| Geometric mean ratio |
| 1.3 |
| 2-Sided |
| 95 |
| 0.6 |
| 3.1 |
| Superiority |
| ANOVA | Analysis of variance was performed with baseline measles titer group as a fixed factor. | 0.5625 | Geometric mean ratio | 1.5 | 2-Sided | 95 | 0.7 | 3.6 | Superiority |
| ANOVA | Analysis of variance was performed with baseline measles titer group as a fixed factor. | 0.5924 | Geometric mean ratio | 1.5 | 2-Sided | 95 | 0.6 | 3.5 | Superiority |
| ANOVA | Analysis of variance was performed with baseline measles titer group as a fixed factor. | 0.3122 | Geometric mean ratio | 1.8 | 2-Sided | 95 | 0.8 | 4.1 | Superiority |
| ANOVA | Analysis of variance was performed with baseline measles titer group as a fixed factor. | 0.9665 | Geometric mean ratio | 1.2 | 2-Sided | 95 | 0.5 | 2.8 | Superiority |