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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861586
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : June 8, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Themis Bioscience GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Chikungunya Virus Infection
Interventions Biological: MV-CHIK low dose
Biological: MV-CHIK high dose
Biological: Priorix®
Biological: physiological saline solution
Enrollment 263
Recruitment Details 322 participants screened for eligibility, 263 participants randomized
Pre-assignment Details 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
Hide 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
Reason Not Completed
Withdrawal by Subject             1             2             0             0             0             1             1             0
Lost to Follow-up             3             1             1             0             0             3             0             0
Adverse Event             0             0             0             0             0             1             0             0
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
Hide 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 Number of Baseline Participants 51 18 47 16 47 50 18 16 263
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 18 participants 47 participants 16 participants 47 participants 50 participants 18 participants 16 participants 263 participants
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)
[1]
Measure Analysis Population Description: Demography and baseline characteristics include 263 participants of the mITT population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 18 participants 47 participants 16 participants 47 participants 50 participants 18 participants 16 participants 263 participants
Female
27
  52.9%
10
  55.6%
29
  61.7%
7
  43.8%
24
  51.1%
27
  54.0%
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
  46.0%
7
  38.9%
11
  68.8%
123
  46.8%
[1]
Measure Analysis Population Description: Demography and baseline characterisitcs of mITT Population including 263 subjects.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 18 participants 47 participants 16 participants 47 participants 50 participants 18 participants 16 participants 263 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.6%
0
   0.0%
0
   0.0%
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%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
1
   2.0%
0
   0.0%
0
   0.0%
2
   0.8%
White
50
  98.0%
17
  94.4%
47
 100.0%
16
 100.0%
45
  95.7%
49
  98.0%
17
  94.4%
16
 100.0%
257
  97.7%
More than one race
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
1
   5.6%
0
   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%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Demography and baseline characteristics including mITT Population of 263 participants
1.Primary Outcome
Title Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Hide 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).
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 49 16 44 16 47 44 16 15
Geometric Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group B; MV-CHIK Low
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group C; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group D; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Measles Booster Group 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group A/C; Priorix®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Treatment Group A; MV-CHIK Low, Treatment Group B/D; Priorix®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group C; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group D; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Measles Booster Group 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group B; MV-CHIK Low
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Treatment Group B; MV-CHIK Low, Treatment Group B/D; Priorix®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Treatment Group C; MV-CHIK High, Treatment Group D; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Treatment Group C; MV-CHIK High, Measles Booster Group 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Treatment Group C; MV-CHIK High, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group C; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Treatment Group C; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Treatment Group D; MV-CHIK High, Measles Booster Group 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Treatment Group D; MV-CHIK High, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group D; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Treatment Group D; MV-CHIK High
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Measles Booster Group 1, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Measles Booster Group 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Measles Booster Group 1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Treatment Group B/D; Priorix®, Measles Booster Group 2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Treatment Group A/C; Priorix®, Treatment Group B/D; Priorix®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M2/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 49 16 44 16 47 44 16 15
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Visit 1 /day 0 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 15 participants 15 participants
28.9  (52.25) 5.0  (0.00)
Visit 5 /day 196 Number Analyzed 46 participants 15 participants 44 participants 16 participants 47 participants 43 participants 15 participants 15 participants
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 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 49 16 44 16 47 44 16 15
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Visit 0 / day -28 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 16 participants 15 participants
542.6  (1118.52) 304.5  (343.53)
Visit 1 / day 0 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 51 18 47 16 47 50 18 16
Measure Type: Count of Participants
Unit of Measure: Participants
35
  68.6%
14
  77.8%
32
  68.1%
10
  62.5%
37
  78.7%
41
  82.0%
13
  72.2%
10
  62.5%
5.Secondary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description Evaluation of all serious adverse events (SAEs) occurred throughout the clinical study. 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 51 18 47 16 47 50 18 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
1
   5.6%
2
   4.3%
1
   6.3%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Shedding of Live Recombinant Virus Until Day 196
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 49 16 44 16 47 44 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 1 /day 0 Number Analyzed 8 participants 4 participants 3 participants 2 participants 8 participants 5 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
day 7 Number Analyzed 8 participants 3 participants 3 participants 2 participants 8 participants 5 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
day 10 Number Analyzed 9 participants 4 participants 4 participants 2 participants 6 participants 3 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
day 14 Number Analyzed 9 participants 3 participants 4 participants 1 participants 7 participants 5 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Visit 2 /day 28 Number Analyzed 8 participants 4 participants 4 participants 2 participants 8 participants 5 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Visit 5 /day 196 Number Analyzed 8 participants 3 participants 4 participants 2 participants 8 participants 5 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
7.Secondary Outcome
Title Chikungunya Virus Specific T Cell Responses
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 51 18 47 16 47 50 18 16
Mean (Standard Deviation)
Unit of Measure: Titer
Visit 1 /day 0 Number Analyzed 11 participants 5 participants 11 participants 4 participants 12 participants 11 participants 2 participants 0 participants
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 Number Analyzed 15 participants 5 participants 0 participants 0 participants 14 participants 0 participants 0 participants 0 participants
41.5  (128.71) 0.0  (0.00) 10.5  (39.29)
Visit 3 /day 56 Number Analyzed 14 participants 5 participants 12 participants 5 participants 14 participants 11 participants 5 participants 4 participants
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 Number Analyzed 15 participants 5 participants 12 participants 5 participants 14 participants 10 participants 5 participants 4 participants
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)
8.Secondary Outcome
Title Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 49 16 44 16 47 44 16 15
Geometric Mean (Standard Deviation)
Unit of Measure: Titer
Visit 1 /day 0 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 49 participants 16 participants 44 participants 16 participants 47 participants 44 participants 16 participants 15 participants
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 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 15 participants 15 participants
9.5  (29.82) 1.8  (2.28)
Visit 5 /day 196 Number Analyzed 46 participants 15 participants 44 participants 16 participants 47 participants 43 participants 16 participants 15 participants
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 Number Analyzed 46 participants 15 participants 44 participants 16 participants 47 participants 43 participants 16 participants 15 participants
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)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/18 (0.00%)      0/47 (0.00%)      0/16 (0.00%)      0/47 (0.00%)      0/50 (0.00%)      0/18 (0.00%)      0/16 (0.00%)    
Hide 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 (1.96%)      1/18 (5.56%)      2/47 (4.26%)      1/16 (6.25%)      0/47 (0.00%)      1/50 (2.00%)      0/18 (0.00%)      0/16 (0.00%)    
Gastrointestinal disorders                 
umbilical hernia * 1  1/51 (1.96%)  1 0/18 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/47 (0.00%)  0/50 (0.00%)  0/18 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications                 
ligament rupture * 2 [1]  0/51 (0.00%)  0/18 (0.00%)  1/47 (2.13%)  1 0/16 (0.00%)  0/47 (0.00%)  0/50 (0.00%)  0/18 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders                 
type 2 diabetes mellitus  6 [2]  0/51 (0.00%)  0/18 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  1 0/47 (0.00%)  0/50 (0.00%)  0/18 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
papillary thyroid cancer * 4 [3]  0/51 (0.00%)  0/18 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/47 (0.00%)  1/50 (2.00%)  1 0/18 (0.00%)  0/16 (0.00%) 
laryngeal cancer * 5 [4]  0/51 (0.00%)  1/18 (5.56%)  1 0/47 (0.00%)  0/16 (0.00%)  0/47 (0.00%)  0/50 (0.00%)  0/18 (0.00%)  0/16 (0.00%) 
Pregnancy, puerperium and perinatal conditions                 
abortion  3 [5]  0/51 (0.00%)  0/18 (0.00%)  1/47 (2.13%)  1 0/16 (0.00%)  0/47 (0.00%)  0/50 (0.00%)  0/18 (0.00%)  0/16 (0.00%) 
1
Term from vocabulary, umbilical hernia
2
Term from vocabulary, ligament rupture
3
Term from vocabulary, abortion
4
Term from vocabulary, papillary thyroid ca
5
Term from vocabulary, laryngeal cancer
6
Term from vocabulary, type 2 diabetes mell
*
Indicates events were collected by non-systematic assessment
[1]
rupture cruciate ligament left knee
Indicates events were collected by systematic assessment
[2]
diabetes mellitus type 2
[3]
papillary thyroid carcinoma
[4]
larynx carcinoma
[5]
suspected abortion
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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   29/51 (56.86%)      10/18 (55.56%)      25/47 (53.19%)      7/16 (43.75%)      22/47 (46.81%)      18/50 (36.00%)      11/18 (61.11%)      9/16 (56.25%)    
Blood and lymphatic system disorders                 
Lymphadenopathy * 1  2/51 (3.92%)  2 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Ear and labyrinth disorders                 
Ear pain * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Vertigo * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 2/16 (12.50%)  2
Eye disorders                 
Dry eye * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Eye pruritus * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders                 
Abdominal pain upper * 1  3/51 (5.88%)  3 0/18 (0.00%)  0 0/47 (0.00%)  0 1/16 (6.25%)  1 2/47 (4.26%)  2 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Diarrhoea * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 1/18 (5.56%)  1 0/16 (0.00%)  0
Abdominal pain * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Toothache * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 0/18 (0.00%)  0 1/16 (6.25%)  1
General disorders                 
Influenza like illness * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  2 1/18 (5.56%)  1 0/16 (0.00%)  0
Fatigue * 1  2/51 (3.92%)  2 0/18 (0.00%)  0 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Axillary pain * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Immune system disorders                 
Seasonal allergy * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  2 1/18 (5.56%)  1 0/16 (0.00%)  0
Infections and infestations                 
Nasopharyngitis * 1  7/51 (13.73%)  7 2/18 (11.11%)  2 4/47 (8.51%)  4 2/16 (12.50%)  3 4/47 (8.51%)  5 4/50 (8.00%)  5 2/18 (11.11%)  5 1/16 (6.25%)  1
Rhinitis * 1  2/51 (3.92%)  2 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 3/47 (6.38%)  3 2/50 (4.00%)  2 2/18 (11.11%)  3 2/16 (12.50%)  2
Upper respiratory tract infection * 1  3/51 (5.88%)  3 1/18 (5.56%)  1 3/47 (6.38%)  4 0/16 (0.00%)  0 1/47 (2.13%)  2 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Urinary tract infection * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 1/47 (2.13%)  1 0/16 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Gingivitis * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Hordeolum * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Respiratory tract infection * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Vaginal infection * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Vulvovaginal candidiasis * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Injury, poisoning and procedural complications                 
Injury * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 1/16 (6.25%)  1 1/47 (2.13%)  1 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Skin abrasion * 1  0/51 (0.00%)  0 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Contusion * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders                 
Appetite disorder * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Back pain * 1  2/51 (3.92%)  2 0/18 (0.00%)  0 2/47 (4.26%)  2 1/16 (6.25%)  1 2/47 (4.26%)  3 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Myalgia * 1  2/51 (3.92%)  2 0/18 (0.00%)  0 2/47 (4.26%)  2 1/16 (6.25%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  4 0/16 (0.00%)  0
Musculoskeletal pain * 1  0/51 (0.00%)  0 1/18 (5.56%)  1 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Bursitis * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Muscle spasms * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Nervous system disorders                 
Headache * 1  7/51 (13.73%)  8 2/18 (11.11%)  2 2/47 (4.26%)  2 1/16 (6.25%)  1 1/47 (2.13%)  1 4/50 (8.00%)  9 1/18 (5.56%)  1 2/16 (12.50%)  2
Renal and urinary disorders                 
Hypertonic bladder * 1  0/51 (0.00%)  0 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Reproductive system and breast disorders                 
Dysmenorrhoea * 1  1/51 (1.96%)  2 0/18 (0.00%)  0 1/47 (2.13%)  3 0/16 (0.00%)  0 1/47 (2.13%)  2 2/50 (4.00%)  8 2/18 (11.11%)  4 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders                 
Oropharyngeal pain * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 1/47 (2.13%)  1 1/16 (6.25%)  1 4/47 (8.51%)  5 1/50 (2.00%)  1 2/18 (11.11%)  3 1/16 (6.25%)  1
Cough * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 2/47 (4.26%)  2 0/16 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 1/18 (5.56%)  1 1/16 (6.25%)  1
Dyspnoea * 1  0/51 (0.00%)  0 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Sneezing * 1  0/51 (0.00%)  0 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Dermatitis contact * 1  1/51 (1.96%)  1 1/18 (5.56%)  1 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Erythema multiforme * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 0/47 (0.00%)  0 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Rash * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 1/18 (5.56%)  1 0/16 (0.00%)  0
Vascular disorders                 
Haematoma * 1  0/51 (0.00%)  0 0/18 (0.00%)  0 1/47 (2.13%)  1 0/16 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA (20.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Themis Bioscience GmbH
ClinicalTrials.gov Identifier: NCT02861586    
Other Study ID Numbers: MV-CHIK-202
2015-004037-26 ( EudraCT Number )
V184-002 ( Other Identifier: Merck & Co., protocol ID since aquisition in May 2020 )
First Submitted: July 28, 2016
First Posted: August 10, 2016
Results First Submitted: March 17, 2021
Results First Posted: June 8, 2021
Last Update Posted: June 8, 2021