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V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)

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: NCT03486834
Recruitment Status : Completed
First Posted : April 3, 2018
Results First Posted : November 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Cytomegalovirus (CMV) Infections
Interventions Biological: V160
Drug: Placebo
Enrollment 2200
Recruitment Details  
Pre-assignment Details A total of approximately 2100 participants were planned to be enrolled with 2200 participants actually randomized.
Arm/Group Title V160 3-Dose Regimen V160 2-Dose Regimen Placebo
Hide Arm/Group Description Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6. Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2. Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Period Title: Overall Study
Started 733 733 734
Treatment 1 729 729 733
Treatment 2 680 680 679
Treatment 3 614 631 622
Completed 614 631 622
Not Completed 119 102 112
Reason Not Completed
Withdrawal by Subject             46             46             52
Adverse Event             8             7             0
Lost to Follow-up             41             24             39
Non-compliance with Study Drug             2             2             0
Physician Decision             5             2             3
Pregnancy             10             12             12
Protocol Deviation             2             3             3
Withdrawal by Parent/Guardian             1             2             2
Randomized but not treated             4             4             1
Arm/Group Title V160 3-Dose Regimen V160 2-Dose Regimen Placebo Total
Hide Arm/Group Description Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6. Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2. Participants received placebo by IM injection on Day 1, Month 2, and Month 6. Total of all reporting groups
Overall Number of Baseline Participants 733 733 734 2200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 733 participants 733 participants 734 participants 2200 participants
26.0  (5.0) 26.1  (4.9) 25.9  (4.9) 26.0  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 733 participants 733 participants 734 participants 2200 participants
Female
733
 100.0%
733
 100.0%
734
 100.0%
2200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 733 participants 733 participants 734 participants 2200 participants
Hispanic or Latino
144
  19.6%
145
  19.8%
143
  19.5%
432
  19.6%
Not Hispanic or Latino
588
  80.2%
585
  79.8%
587
  80.0%
1760
  80.0%
Unknown or Not Reported
1
   0.1%
3
   0.4%
4
   0.5%
8
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 733 participants 733 participants 734 participants 2200 participants
American Indian or Alaska Native
0
   0.0%
1
   0.1%
4
   0.5%
5
   0.2%
Asian
6
   0.8%
7
   1.0%
6
   0.8%
19
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
47
   6.4%
49
   6.7%
43
   5.9%
139
   6.3%
White
657
  89.6%
652
  88.9%
665
  90.6%
1974
  89.7%
More than one race
23
   3.1%
23
   3.1%
16
   2.2%
62
   2.8%
Unknown or Not Reported
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.0%
1.Primary Outcome
Title Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)
Hide Description Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.
Time Frame 4 weeks post last vaccination (Month 7) up to ~Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 3 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.
Arm/Group Title V160 3-Dose Regimen Placebo
Hide Arm/Group Description:
Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Number of Participants Analyzed 556 543
Measure Type: Count of Participants
Unit of Measure: Participants
14
   2.5%
24
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V160 3-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).
Method of Estimation Estimation Parameter Incidence Rate Estimate
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
1.6 to 4.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V160 3-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.
Method of Estimation Estimation Parameter Incidence Rate Estimate
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
3.3 to 7.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V160 3-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 42.4
Confidence Interval (2-Sided) 95%
-13.5 to 71.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Solicited Injection-site Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.
Time Frame Up to 5 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.
Arm/Group Title V160 3-Dose Regimen V160 2-Dose Regimen Placebo
Hide Arm/Group Description:
Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Number of Participants Analyzed 728 729 732
Measure Type: Count of Participants
Unit of Measure: Participants
683
  93.8%
668
  91.6%
249
  34.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V160 3-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 59.8
Confidence Interval (2-Sided) 95%
55.8 to 63.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V160 2-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 57.6
Confidence Interval (2-Sided) 95%
53.5 to 61.5
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Solicited Systemic AEs
Hide Description An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.
Time Frame Up to 14 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.
Arm/Group Title V160 3-Dose Regimen V160 2-Dose Regimen Placebo
Hide Arm/Group Description:
Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Number of Participants Analyzed 728 729 732
Measure Type: Count of Participants
Unit of Measure: Participants
621
  85.3%
633
  86.8%
508
  69.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V160 3-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 15.9
Confidence Interval (2-Sided) 95%
11.7 to 20.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V160 2-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 17.4
Confidence Interval (2-Sided) 95%
13.3 to 21.6
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With Vaccine-related Serious Adverse Events
Hide Description A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.
Time Frame Up to 14 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.
Arm/Group Title V160 3-Dose Regimen V160 2-Dose Regimen Placebo
Hide Arm/Group Description:
Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Number of Participants Analyzed 728 729 732
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V160 3-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.5 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V160 2-Dose Regimen, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.5 to 0.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)
Hide Description CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.
Time Frame 4 weeks post last vaccination (Month 7) up to ~Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 2 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.
Arm/Group Title V160 2-Dose Regimen Placebo
Hide Arm/Group Description:
Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Number of Participants Analyzed 546 543
Measure Type: Count of Participants
Unit of Measure: Participants
31
   5.7%
24
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V160 2-Dose Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.
Method of Estimation Estimation Parameter Incidence Rate Estimate
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
4.6 to 9.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.
Method of Estimation Estimation Parameter Incidence Rate Estimate
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
3.3 to 7.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V160 2-Dose Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value -32.0
Confidence Interval (2-Sided) 95%
-135.0 to 25.0
Estimation Comments [Not Specified]
Time Frame All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination.
Adverse Event Reporting Description The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
 
Arm/Group Title V160 3-Dose Group V160 2-Dose Group Placebo Group
Hide Arm/Group Description Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6. Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2. Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
All-Cause Mortality
V160 3-Dose Group V160 2-Dose Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/733 (0.00%)      0/733 (0.00%)      0/734 (0.00%)    
Hide Serious Adverse Events
V160 3-Dose Group V160 2-Dose Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/728 (3.02%)      29/729 (3.98%)      26/732 (3.55%)    
Cardiac disorders       
Cardiac arrest  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Tachycardia  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/728 (0.00%)  0 1/729 (0.14%)  1 1/732 (0.14%)  1
Abdominal pain lower  1  1/728 (0.14%)  1 1/729 (0.14%)  1 0/732 (0.00%)  0
Oesophageal ulcer  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Salivary gland calculus  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
General disorders       
Asthenia  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Chest pain  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Fatigue  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  0/728 (0.00%)  0 2/729 (0.27%)  2 0/732 (0.00%)  0
Infections and infestations       
Appendicitis  1  0/728 (0.00%)  0 1/729 (0.14%)  1 1/732 (0.14%)  1
Appendicitis perforated  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Breast abscess  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
COVID-19 pneumonia  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Cellulitis  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Epstein-Barr virus infection  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Infection  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Pharyngotonsillitis  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Pneumonia  1  1/728 (0.14%)  1 2/729 (0.27%)  2 0/732 (0.00%)  0
Pyelonephritis  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Pyelonephritis acute  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Urinary tract infection  1  0/728 (0.00%)  0 2/729 (0.27%)  2 0/732 (0.00%)  0
Injury, poisoning and procedural complications       
Ankle fracture  1  0/728 (0.00%)  0 2/729 (0.27%)  2 1/732 (0.14%)  1
Chest injury  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Concussion  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Intentional overdose  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Pelvic bone injury  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Procedural haemorrhage  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Radius fracture  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Rib fracture  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Splenic rupture  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Tendon rupture  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Tibia fracture  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Traumatic arthropathy  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Enchondromatosis  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Ovarian germ cell teratoma benign  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Nervous system disorders       
Epilepsy  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Idiopathic intracranial hypertension  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Seizure  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Pregnancy, puerperium and perinatal conditions       
Abortion missed  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Abortion spontaneous  1  2/728 (0.27%)  2 6/729 (0.82%)  6 7/732 (0.96%)  7
Anembryonic gestation  1  0/728 (0.00%)  0 0/729 (0.00%)  0 2/732 (0.27%)  2
Eclampsia  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Ectopic pregnancy  1  0/728 (0.00%)  0 0/729 (0.00%)  0 2/732 (0.27%)  2
Postpartum haemorrhage  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Pre-eclampsia  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Ruptured ectopic pregnancy  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Threatened labour  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  2
Psychiatric disorders       
Alcohol abuse  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Anxiety  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Depression  1  2/728 (0.27%)  2 0/729 (0.00%)  0 1/732 (0.14%)  1
Suicidal ideation  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Suicide attempt  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Renal and urinary disorders       
Renal colic  1  0/728 (0.00%)  0 1/729 (0.14%)  2 0/732 (0.00%)  0
Renal impairment  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Ureterolithiasis  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Reproductive system and breast disorders       
Adnexal torsion  1  1/728 (0.14%)  1 0/729 (0.00%)  0 0/732 (0.00%)  0
Intermenstrual bleeding  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Ovarian cyst  1  0/728 (0.00%)  0 1/729 (0.14%)  1 1/732 (0.14%)  1
Ovarian cyst ruptured  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/728 (0.00%)  0 0/729 (0.00%)  0 1/732 (0.14%)  1
Vascular disorders       
Haemorrhage  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
Hypotension  1  0/728 (0.00%)  0 1/729 (0.14%)  1 0/732 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
V160 3-Dose Group V160 2-Dose Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   697/728 (95.74%)      700/729 (96.02%)      557/732 (76.09%)    
Gastrointestinal disorders       
Nausea  1  45/728 (6.18%)  50 55/729 (7.54%)  68 46/732 (6.28%)  54
General disorders       
Fatigue  1  457/728 (62.77%)  1128 461/729 (63.24%)  1077 357/732 (48.77%)  843
Injection site erythema  1  254/728 (34.89%)  400 208/729 (28.53%)  273 30/732 (4.10%)  39
Injection site pain  1  680/728 (93.41%)  1943 664/729 (91.08%)  1524 239/732 (32.65%)  374
Injection site pruritus  1  44/728 (6.04%)  54 26/729 (3.57%)  34 4/732 (0.55%)  5
Injection site swelling  1  248/728 (34.07%)  404 233/729 (31.96%)  311 21/732 (2.87%)  26
Pyrexia  1  75/728 (10.30%)  93 90/729 (12.35%)  112 27/732 (3.69%)  42
Infections and infestations       
Nasopharyngitis  1  53/728 (7.28%)  59 53/729 (7.27%)  56 37/732 (5.05%)  40
Musculoskeletal and connective tissue disorders       
Arthralgia  1  162/728 (22.25%)  226 162/729 (22.22%)  249 76/732 (10.38%)  121
Myalgia  1  455/728 (62.50%)  996 424/729 (58.16%)  818 200/732 (27.32%)  336
Nervous system disorders       
Headache  1  434/728 (59.62%)  988 450/729 (61.73%)  976 368/732 (50.27%)  795
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  62/728 (8.52%)  81 65/729 (8.92%)  80 69/732 (9.43%)  80
1
Term from vocabulary, MedDRA 24.0
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.
If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
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 LLC
ClinicalTrials.gov Identifier: NCT03486834    
Other Study ID Numbers: V160-002
2017-004233-86 ( EudraCT Number )
First Submitted: March 28, 2018
First Posted: April 3, 2018
Results First Submitted: October 1, 2021
Results First Posted: November 10, 2021
Last Update Posted: November 10, 2021