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Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)

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: NCT02503202
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Prevention of Ebola Infection
Interventions Biological: V920 Consistency Lot A
Biological: V920 Consistency Lot B
Biological: V920 Consistency Lot C
Biological: V920 High-dose Lot
Biological: Placebo to V920
Enrollment 1197
Recruitment Details  
Pre-assignment Details A total of 1261 participants were screened and 1197 were randomized.
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Period Title: Base Study: Up to Month 6
Started 266 265 267 266 133
Vaccinated 266 265 266 264 133
Completed 248 253 252 255 130
Not Completed 18 12 15 11 3
Reason Not Completed
Death             1             1             0             0             0
Lost to Follow-up             11             8             10             5             1
Physician Decision             0             0             0             0             1
Withdrawal by Subject             6             3             4             4             1
Randomized not vaccinated             0             0             1             2             0
Period Title: Extension: Month 6 to 24
Started [1] 119 130 112 137 68
Completed 108 114 103 119 67
Not Completed 11 16 9 18 1
Reason Not Completed
Protocol Violation             0             0             0             1             0
Death             1             0             0             0             0
Lost to Follow-up             4             8             6             10             1
Physician Decision             1             0             1             3             0
Withdrawal by Subject             5             8             2             4             0
[1]
A subset of US participants enrolled in Extension Study
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo Total
Hide Arm/Group Description Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 Participants received a 1.0-mL intramuscular injection of placebo on Day 1 Total of all reporting groups
Overall Number of Baseline Participants 266 265 267 266 133 1197
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 266 participants 265 participants 267 participants 266 participants 133 participants 1197 participants
41.3  (13.4) 41.5  (12.4) 40.9  (13.1) 41.7  (13.4) 41.1  (13.7) 41.3  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 266 participants 265 participants 267 participants 266 participants 133 participants 1197 participants
Female
143
  53.8%
135
  50.9%
138
  51.7%
149
  56.0%
72
  54.1%
637
  53.2%
Male
123
  46.2%
130
  49.1%
129
  48.3%
117
  44.0%
61
  45.9%
560
  46.8%
1.Primary Outcome
Title Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
Hide Description Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.
Time Frame Day 28 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 239 231 226 219 124
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
1183.9
(1038.7 to 1349.4)
1266.0
(1108.2 to 1446.2)
1346.0
(1176.6 to 1539.9)
1291.9
(1126.9 to 1481.2)
NA [1] 
(NA to NA)
[1]
Geometric Mean and CIs are <36.11 EU/mL
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.
Statistical Test of Hypothesis P-Value <0.001
Comments Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (Lot A / Lot B)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.77 to 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.
Statistical Test of Hypothesis P-Value <0.001
Comments Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (Lot A / Lot C)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.71 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.
Statistical Test of Hypothesis P-Value <0.001
Comments Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (Lot B / Lot C)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.77 to 1.15
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Reporting Serious Adverse Events
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.
Time Frame Up to Month 6 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received vaccination and had follow-up data for the outcome measure
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 265 263 263 260 133
Measure Type: Number
Unit of Measure: Percentage of participants
2.6 1.5 2.7 1.2 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-1.5 to 4.0
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.989
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-3.1 to 3.0
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-4.1 to 1.5
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-1.7 to 3.3
Estimation Comments Risk difference is High-dose Lot - Placebo
3.Primary Outcome
Title Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.
Time Frame Up to Day 5 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received vaccination and had follow-up data for the outcome measure
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 265 263 263 260 133
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site erythema 14.7 10.6 14.8 7.3 1.5
Injection-site pain 66.8 73.0 70.3 67.7 12.8
Injection-site swelling 17.7 13.7 18.3 16.2 3.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments Injection site erythema
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-1.6 to 9.9
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments Injection site erythema
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.971
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-6.2 to 6.0
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments Injection site erythema
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-10.0 to 1.5
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments Injection site erythema
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
1.4 to 9.9
Estimation Comments Risk difference is High-dose Lot - Placebo
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments Injection site pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-14.0 to 1.6
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments Injection site pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.380
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.5
Confidence Interval (2-Sided) 94%
-11.4 to 4.4
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments Injection site pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.499
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-5.1 to 10.4
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments Injection site pain
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 54.9
Confidence Interval (2-Sided) 95%
46.2 to 62.3
Estimation Comments Risk difference is High-dose Lot - Placebo
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments Injection site swelling
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-2.2 to 10.3
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments Injection site swelling
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.878
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-7.1 to 6.1
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments Injection site swelling
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-10.9 to 1.7
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments Injection site swelling
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.1
Confidence Interval (2-Sided) 95%
7.4 to 18.6
Estimation Comments Risk difference is High-dose Lot - Placebo
4.Primary Outcome
Title Percentage of Participants With Elevated Maximum Temperature
Hide Description Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).
Time Frame Up to Day 42 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received vaccination and had follow-up data for the outcome measure
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 262 263 263 258 132
Measure Type: Number
Unit of Measure: Percentage of participants
21.4 16.7 22.4 32.2 0.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-2.1 to 11.4
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-8.2 to 6.0
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-12.5 to 1.1
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 31.4
Confidence Interval (2-Sided) 95%
25.6 to 37.5
Estimation Comments Risk difference is High-dose Lot - Placebo
5.Primary Outcome
Title Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.
Time Frame From Day 5 to Day 42 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received vaccination and had follow-up data for the outcome measure
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 265 263 263 260 133
Measure Type: Number
Unit of Measure: Percentage of participants
Arthralgia AEs 5.7 5.7 6.5 7.7 1.5
Arthritis AEs 4.5 3.8 2.7 3.1 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments Arthralgia
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.983
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-4.2 to 4.1
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments Arthralgia
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.699
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-5.1 to 3.4
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments Arthralgia
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.716
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-5.1 to 3.5
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments Arthralgia
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.2
Confidence Interval (2-Sided) 95%
1.8 to 10.4
Estimation Comments Risk difference is High-dose Lot - Placebo
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments Arthritis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.9 to 4.4
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments Arthritis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-1.4 to 5.4
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments Arthritis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.460
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-2.1 to 4.5
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments Arthritis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
0.2 to 6.0
Estimation Comments Risk difference is High-dose Lot - Placebo
6.Primary Outcome
Title Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.
Time Frame Up to Day 42 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received vaccination and had follow-up data for the outcome measure
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 265 263 263 260 133
Measure Type: Number
Unit of Measure: Percentage of participants
3.0 4.6 3.8 3.8 1.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-5.1 to 1.9
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.620
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-4.2 to 2.5
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.663
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-2.9 to 4.5
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-1.8 to 5.7
Estimation Comments Risk difference is High-dose Lot - Placebo
7.Primary Outcome
Title Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.
Time Frame Up to Day 42 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received vaccination and had follow-up data for the outcome measure
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description:
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1
Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1
Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1
Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Overall Number of Participants Analyzed 265 263 263 260 133
Measure Type: Number
Unit of Measure: Percentage of participants
1.9 1.1 1.5 1.5 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot B
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.6 to 3.3
Estimation Comments Risk difference is Lot A - Lot B
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot A, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-2.2 to 3.0
Estimation Comments Risk difference is Lot A - Lot C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V920 Consistency Lot B, V920 Consistency Lot C
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.704
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.8 to 2.0
Estimation Comments Risk difference is Lot B - Lot C
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V920 High-dose Lot, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-1.3 to 3.9
Estimation Comments Risk difference is High-dose Lot - Placebo
Time Frame Up to Month 24
Adverse Event Reporting Description The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
 
Arm/Group Title V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Hide Arm/Group Description Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1 Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1 Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1 Participants received a 1.0-mL intramuscular injection of placebo on Day 1
All-Cause Mortality
V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/265 (0.75%)      1/263 (0.38%)      0/263 (0.00%)      0/260 (0.00%)      0/133 (0.00%)    
Hide Serious Adverse Events
V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/265 (4.53%)      12/263 (4.56%)      11/263 (4.18%)      8/260 (3.08%)      4/133 (3.01%)    
Ear and labyrinth disorders           
Conductive deafness  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Endocrine disorders           
Autoimmune thyroiditis  1  0/265 (0.00%)  0 1/263 (0.38%)  1 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Hyperthyroidism  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Gastrointestinal disorders           
Abdominal incarcerated hernia  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 1/133 (0.75%)  1
Abdominal pain  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Gastrointestinal disorder  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Gastrooesophageal reflux disease  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Incarcerated umbilical hernia  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Hepatic failure  1  1/265 (0.38%)  1 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Infections and infestations           
Appendicitis  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Cellulitis  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Clostridium difficile infection  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Diverticulitis  1  1/265 (0.38%)  2 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Mastitis  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Meningitis aseptic  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 1/133 (0.75%)  1
Pneumonia  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Upper respiratory tract infection  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Urinary tract infection  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Injury, poisoning and procedural complications           
Animal bite  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Arthropod bite  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 1/133 (0.75%)  1
Craniocerebral injury  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Femur fracture  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Rib fracture  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Road traffic accident  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Scapula fracture  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Investigations           
Platelet count decreased  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 1/133 (0.75%)  1
Metabolism and nutrition disorders           
Hyperglycaemic hyperosmolar nonketotic syndrome  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Exostosis  1  1/265 (0.38%)  2 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Foot deformity  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Musculoskeletal chest pain  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Spinal column stenosis  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 1/260 (0.38%)  1 0/133 (0.00%)  0
Breast cancer  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Breast cancer stage III  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 1/133 (0.75%)  1
Oropharyngeal squamous cell carcinoma  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Nervous system disorders           
Migraine  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Radicular pain  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  1/265 (0.38%)  1 1/263 (0.38%)  1 1/263 (0.38%)  1 0/260 (0.00%)  0 1/133 (0.75%)  1
Ruptured ectopic pregnancy  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Psychiatric disorders           
Schizophrenia  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Suicidal ideation  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 1/260 (0.38%)  1 0/133 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Renal failure  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Reproductive system and breast disorders           
Menometrorrhagia  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/265 (0.00%)  0 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Haemothorax  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Hypoxia  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Pneumothorax  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Pulmonary embolism  1  1/265 (0.38%)  1 0/263 (0.00%)  0 1/263 (0.38%)  1 0/260 (0.00%)  0 0/133 (0.00%)  0
Respiratory failure  1  0/265 (0.00%)  0 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 1/133 (0.75%)  1
Skin and subcutaneous tissue disorders           
Angioedema  1  0/265 (0.00%)  0 1/263 (0.38%)  1 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Vascular disorders           
Deep vein thrombosis  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
Hypertension  1  1/265 (0.38%)  1 0/263 (0.00%)  0 0/263 (0.00%)  0 0/260 (0.00%)  0 0/133 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
V920 Consistency Lot A V920 Consistency Lot B V920 Consistency Lot C V920 High-dose Lot Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   211/265 (79.62%)      211/263 (80.23%)      208/263 (79.09%)      208/260 (80.00%)      35/133 (26.32%)    
Gastrointestinal disorders           
Nausea  1  12/265 (4.53%)  12 13/263 (4.94%)  13 15/263 (5.70%)  16 14/260 (5.38%)  15 1/133 (0.75%)  1
General disorders           
Chills  1  14/265 (5.28%)  14 16/263 (6.08%)  16 20/263 (7.60%)  20 27/260 (10.38%)  27 1/133 (0.75%)  1
Fatigue  1  21/265 (7.92%)  22 15/263 (5.70%)  15 9/263 (3.42%)  9 20/260 (7.69%)  21 3/133 (2.26%)  3
Influenza like illness  1  14/265 (5.28%)  14 12/263 (4.56%)  13 18/263 (6.84%)  19 9/260 (3.46%)  9 1/133 (0.75%)  1
Injection site erythema  1  39/265 (14.72%)  43 30/263 (11.41%)  30 39/263 (14.83%)  42 19/260 (7.31%)  23 2/133 (1.50%)  2
Injection site pain  1  179/265 (67.55%)  198 192/263 (73.00%)  215 185/263 (70.34%)  212 176/260 (67.69%)  192 18/133 (13.53%)  19
Injection site swelling  1  47/265 (17.74%)  51 36/263 (13.69%)  40 49/263 (18.63%)  52 42/260 (16.15%)  42 4/133 (3.01%)  4
Pain  1  34/265 (12.83%)  34 23/263 (8.75%)  23 29/263 (11.03%)  30 32/260 (12.31%)  33 2/133 (1.50%)  2
Pyrexia  1  58/265 (21.89%)  66 47/263 (17.87%)  47 63/263 (23.95%)  70 76/260 (29.23%)  83 1/133 (0.75%)  4
Musculoskeletal and connective tissue disorders           
Arthralgia  1  47/265 (17.74%)  72 41/263 (15.59%)  74 50/263 (19.01%)  75 53/260 (20.38%)  79 4/133 (3.01%)  7
Myalgia  1  17/265 (6.42%)  19 11/263 (4.18%)  13 12/263 (4.56%)  12 23/260 (8.85%)  23 1/133 (0.75%)  1
Nervous system disorders           
Headache  1  61/265 (23.02%)  72 51/263 (19.39%)  56 55/263 (20.91%)  68 67/260 (25.77%)  83 15/133 (11.28%)  18
1
Term from vocabulary, MedDRA version 20.1
Indicates events were collected by 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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02503202    
Other Study ID Numbers: V920-012
2015-001658-14 ( EudraCT Number )
V920-012 ( Other Identifier: Merck Protocol Number )
First Submitted: July 17, 2015
First Posted: July 20, 2015
Results First Submitted: September 7, 2018
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018