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Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

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: NCT04665050
Recruitment Status : Completed
First Posted : December 11, 2020
Results First Posted : July 7, 2023
Last Update Posted : October 4, 2023
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 Pneumococcal Infection
Interventions Biological: V116
Biological: PNEUMOVAX™23
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Period Title: Overall Study
Started 51 51
Completed 51 51
Not Completed 0 0
Arm/Group Title V116 PNEUMOVAX™23 Total
Hide Arm/Group Description Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 51 51 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 102 participants
63.1  (13.7) 64.0  (12.7) 63.6  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Female
28
  54.9%
24
  47.1%
52
  51.0%
Male
23
  45.1%
27
  52.9%
50
  49.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
51
 100.0%
51
 100.0%
102
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
51
 100.0%
51
 100.0%
102
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.
Time Frame Up to 5 days postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percentage of Participants
Injection site erythema 9.8 9.8
Injection site pain 54.9 66.7
Injection site swelling 13.7 13.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Injection Site Erythema
Type of Statistical Test Other
Comments Estimated difference and confidence interval (CI) are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-12.7 to 12.7
Estimation Comments V116 minus PNEUMOVAX™23
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Injection Site Pain
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -11.8
Confidence Interval (2-Sided) 95%
-30.0 to 7.3
Estimation Comments V116 minus PNEUMOVAX™23
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Injection Site Swelling
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-14.1 to 14.1
Estimation Comments V116 minus PNEUMOVAX™23
2.Primary Outcome
Title Percentage of Participants With a Solicited Systemic AE
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.
Time Frame Up to 5 days postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percentage of participants
Fatigue 13.7 9.8
Arthralgia 3.9 3.9
Myalgia 17.6 19.6
Headache 9.8 9.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Fatigue
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-9.4 to 17.5
Estimation Comments V116 minus PNEUMOVAX™23
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Arthralgia
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-9.9 to 9.9
Estimation Comments V116 minus PNEUMOVAX™23
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Myalgia
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-17.5 to 13.6
Estimation Comments V116 minus PNEUMOVAX™23
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Headache
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-12.7 to 12.7
Estimation Comments V116 minus PNEUMOVAX™23
3.Primary Outcome
Title Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
Hide Description An SAE is an AE that results in death, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.
Time Frame Up to 62 days postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimated difference and CI are calculated based on the Miettinen & Nurminen method
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-7.1 to 7.1
Estimation Comments V116 minus PNEUMOVAX™23
4.Secondary Outcome
Title Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Hide Description The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated.
Time Frame Day 30 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 3
161.08 [1] 
(NA to NA)
100.76 [1] 
(NA to NA)
Serotype 7F
5327.67 [1] 
(NA to NA)
4406.11 [1] 
(NA to NA)
Serotype 19A
1479.82 [1] 
(NA to NA)
738.52 [1] 
(NA to NA)
Serotype 22F
5768.79 [1] 
(NA to NA)
3000.50 [1] 
(NA to NA)
Serotype 33F
33187.25 [1] 
(NA to NA)
28831.77 [1] 
(NA to NA)
Serotype 8
1287.66 [1] 
(NA to NA)
721.85 [1] 
(NA to NA)
Serotype 9N
6555.82 [1] 
(NA to NA)
3466.72 [1] 
(NA to NA)
Serotype 10A
3608.34 [1] 
(NA to NA)
1330.75 [1] 
(NA to NA)
Serotype 11A
1467.66 [1] 
(NA to NA)
603.00 [1] 
(NA to NA)
Serotype 12F
1356.20 [1] 
(NA to NA)
563.99 [1] 
(NA to NA)
Serotype 17F
8470.21 [1] 
(NA to NA)
3293.31 [1] 
(NA to NA)
Serotype 20A
3542.90 [1] 
(NA to NA)
1553.99 [1] 
(NA to NA)
[1]
NA means that per protocol, no within-group MOD were planned or calculated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 3
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.07 to 2.40
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 7F
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.69 to 2.11
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 19A
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
1.24 to 3.24
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 22F
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.92
Confidence Interval (2-Sided) 95%
1.04 to 3.57
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 33F
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.71 to 1.86
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 8
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
1.24 to 2.58
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 9N
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
1.19 to 3.00
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 10A
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.71
Confidence Interval (2-Sided) 95%
1.47 to 5.00
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 11A
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.43
Confidence Interval (2-Sided) 95%
1.52 to 3.89
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 12F
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.40
Confidence Interval (2-Sided) 95%
1.20 to 4.83
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 17F
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.57
Confidence Interval (2-Sided) 95%
1.59 to 4.17
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 20A
Type of Statistical Test Other
Comments GMT ratio and 95% confidence interval CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.28
Confidence Interval (2-Sided) 95%
1.46 to 3.56
Estimation Comments V116/PNEUMOVAX™23
5.Secondary Outcome
Title Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Hide Description The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Time Frame Day 30 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 3
1.13 [1] 
(NA to NA)
0.73 [1] 
(NA to NA)
Serotype 7F
10.29 [1] 
(NA to NA)
4.66 [1] 
(NA to NA)
Serotype 19A
10.75 [1] 
(NA to NA)
4.97 [1] 
(NA to NA)
Serotype 22F
3.94 [1] 
(NA to NA)
1.69 [1] 
(NA to NA)
Serotype 33F
22.00 [1] 
(NA to NA)
14.48 [1] 
(NA to NA)
Serotype 8
19.38 [1] 
(NA to NA)
10.33 [1] 
(NA to NA)
Serotype 9N
14.17 [1] 
(NA to NA)
5.99 [1] 
(NA to NA)
Serotype 10A
11.13 [1] 
(NA to NA)
5.16 [1] 
(NA to NA)
Serotype 11A
9.07 [1] 
(NA to NA)
4.71 [1] 
(NA to NA)
Serotype 12F
2.87 [1] 
(NA to NA)
0.82 [1] 
(NA to NA)
Serotype 17F
19.46 [1] 
(NA to NA)
6.77 [1] 
(NA to NA)
Serotype 20A
23.53 [1] 
(NA to NA)
11.46 [1] 
(NA to NA)
[1]
NA means that per protocol, no within-group MOD were planned or calculated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 3
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.08 to 2.21
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 7F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.36 to 3.60
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 19A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.16
Confidence Interval (2-Sided) 95%
1.45 to 3.23
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 22F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.33
Confidence Interval (2-Sided) 95%
1.36 to 3.99
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 33F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.97 to 2.37
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 8
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.32 to 2.68
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 9N
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.37
Confidence Interval (2-Sided) 95%
1.49 to 3.74
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 10A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.16
Confidence Interval (2-Sided) 95%
1.28 to 3.65
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 11A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 1.92
Confidence Interval (2-Sided) 95%
1.28 to 2.89
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 12F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 3.49
Confidence Interval (2-Sided) 95%
1.94 to 6.27
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 17F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.88
Confidence Interval (2-Sided) 95%
1.92 to 4.31
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 20A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 2.05
Confidence Interval (2-Sided) 95%
1.30 to 3.25
Estimation Comments V116/PNEUMOVAX™23
6.Secondary Outcome
Title Serotype-specific OPA GMTs for the Unique Serotypes in V116
Hide Description The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Time Frame Day 30 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 6A
1663.20 [1] 
(NA to NA)
464.65 [1] 
(NA to NA)
Serotype 15A
5030.66 [1] 
(NA to NA)
807.16 [1] 
(NA to NA)
Serotype 15C
3641.84 [1] 
(NA to NA)
1565.56 [1] 
(NA to NA)
Serotype 16F
2459.26 [1] 
(NA to NA)
244.49 [1] 
(NA to NA)
Serotype 23A
2620.19 [1] 
(NA to NA)
62.26 [1] 
(NA to NA)
Serotype 23B
2065.39 [1] 
(NA to NA)
167.03 [1] 
(NA to NA)
Serotype 24F
2742.93 [1] 
(NA to NA)
110.53 [1] 
(NA to NA)
Serotype 31
1699.54 [1] 
(NA to NA)
66.24 [1] 
(NA to NA)
Serotype 35B
4992.58 [1] 
(NA to NA)
349.07 [1] 
(NA to NA)
[1]
NA means that per protocol, no within-group MOD were planned or calculated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 6A
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.58
Confidence Interval (2-Sided) 95%
1.86 to 6.88
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 15A
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 6.23
Confidence Interval (2-Sided) 95%
3.54 to 10.98
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 15C
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.33
Confidence Interval (2-Sided) 95%
1.23 to 4.39
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 16F
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 10.06
Confidence Interval (2-Sided) 95%
5.39 to 18.78
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 23A
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 42.09
Confidence Interval (2-Sided) 95%
19.67 to 90.03
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 23B
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 12.37
Confidence Interval (2-Sided) 95%
6.97 to 21.94
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 24F
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 24.82
Confidence Interval (2-Sided) 95%
11.65 to 52.86
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 31
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 25.66
Confidence Interval (2-Sided) 95%
14.65 to 44.93
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 35B
Type of Statistical Test Other
Comments GMT ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 14.30
Confidence Interval (2-Sided) 95%
8.72 to 23.47
Estimation Comments V116/PNEUMOVAX™23
7.Secondary Outcome
Title Serotype-specific IgG GMCs for the Unique Serotypes in V116
Hide Description The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Time Frame Day 30 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 6A
6.38 [1] 
(NA to NA)
2.13 [1] 
(NA to NA)
Serotype 15A
16.39 [1] 
(NA to NA)
2.04 [1] 
(NA to NA)
Serotype 15C
21.42 [1] 
(NA to NA)
6.81 [1] 
(NA to NA)
Serotype 16F
5.57 [1] 
(NA to NA)
0.43 [1] 
(NA to NA)
Serotype 23A
4.14 [1] 
(NA to NA)
0.48 [1] 
(NA to NA)
Serotype 23B
8.56 [1] 
(NA to NA)
2.06 [1] 
(NA to NA)
Serotype 24F
13.99 [1] 
(NA to NA)
0.49 [1] 
(NA to NA)
Serotype 31
5.25 [1] 
(NA to NA)
0.51 [1] 
(NA to NA)
Serotype 35B
24.61 [1] 
(NA to NA)
1.54 [1] 
(NA to NA)
[1]
NA means that per protocol, no within-group MOD were planned or calculated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 6A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 3.00
Confidence Interval (2-Sided) 95%
1.73 to 5.19
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 15A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 8.03
Confidence Interval (2-Sided) 95%
4.61 to 13.98
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 15C
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 3.14
Confidence Interval (2-Sided) 95%
1.77 to 5.58
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 16F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 13.06
Confidence Interval (2-Sided) 95%
8.45 to 20.19
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 23A
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 8.55
Confidence Interval (2-Sided) 95%
5.19 to 14.09
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 23B
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 4.15
Confidence Interval (2-Sided) 95%
2.72 to 6.36
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 24F
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 28.68
Confidence Interval (2-Sided) 95%
16.59 to 49.58
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 31
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 10.27
Confidence Interval (2-Sided) 95%
6.71 to 15.73
Estimation Comments V116/PNEUMOVAX™23
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection V116, PNEUMOVAX™23
Comments Serotype 35B
Type of Statistical Test Other
Comments GMC ratio and 95% CI are estimated from a cLDA model.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 15.95
Confidence Interval (2-Sided) 95%
11.62 to 21.90
Estimation Comments V116/PNEUMOVAX™23
8.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Hide Description GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Time Frame Baseline (Day 1) and Day 30 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Serotype 3 Number Analyzed 51 participants 51 participants
9.86
(7.07 to 13.75)
6.35
(4.43 to 9.10)
Serotype 7F Number Analyzed 50 participants 51 participants
19.79
(10.60 to 36.94)
21.53
(11.79 to 39.30)
Serotype 19A Number Analyzed 51 participants 51 participants
10.80
(7.27 to 16.04)
6.74
(4.45 to 10.18)
Serotype 22F Number Analyzed 51 participants 49 participants
15.14
(8.25 to 27.79)
18.13
(9.17 to 35.85)
Serotype 33F Number Analyzed 51 participants 51 participants
11.47
(8.20 to 16.04)
11.62
(7.91 to 17.06)
Serotype 8 Number Analyzed 51 participants 51 participants
102.33
(75.07 to 139.50)
48.14
(32.69 to 70.88)
Serotype 9N Number Analyzed 49 participants 51 participants
55.49
(31.26 to 98.50)
40.11
(22.97 to 70.03)
Serotype 10A Number Analyzed 49 participants 49 participants
31.29
(15.34 to 63.81)
21.93
(12.29 to 39.11)
Serotype 11A Number Analyzed 51 participants 48 participants
42.06
(25.15 to 70.32)
20.68
(12.11 to 35.33)
Serotype 12F Number Analyzed 48 participants 50 participants
94.74
(54.15 to 165.76)
44.70
(24.59 to 81.24)
Serotype 17F Number Analyzed 51 participants 49 participants
23.63
(13.40 to 41.68)
11.40
(7.07 to 18.40)
Serotype 20A Number Analyzed 51 participants 51 participants
11.69
(7.27 to 18.81)
5.94
(4.12 to 8.57)
Serotype 6A Number Analyzed 50 participants 51 participants
22.76
(12.66 to 40.93)
8.31
(5.24 to 13.17)
Serotype 15A Number Analyzed 51 participants 51 participants
10.70
(6.31 to 18.13)
3.02
(1.67 to 5.43)
Serotype 15C Number Analyzed 50 participants 48 participants
36.53
(18.49 to 72.15)
16.72
(9.39 to 29.76)
Serotype 16F Number Analyzed 51 participants 50 participants
14.74
(8.27 to 26.28)
1.84
(1.10 to 3.06)
Serotype 23A Number Analyzed 50 participants 51 participants
46.69
(25.58 to 85.22)
1.93
(1.05 to 3.56)
Serotype 23B Number Analyzed 50 participants 51 participants
43.21
(25.15 to 74.23)
4.43
(3.00 to 6.54)
Serotype 24F Number Analyzed 47 participants 45 participants
9.21
(5.06 to 16.78)
0.75
(0.40 to 1.40)
Serotype 31 Number Analyzed 51 participants 51 participants
27.99
(16.04 to 48.85)
1.22
(0.75 to 2.01)
Serotype 35B Number Analyzed 51 participants 51 participants
7.39
(4.32 to 12.67)
0.56
(0.41 to 0.78)
Serotype 6C Number Analyzed 51 participants 50 participants
5.63
(3.17 to 9.99)
4.00
(2.21 to 7.24)
Serotype 15B Number Analyzed 50 participants 49 participants
35.68
(18.43 to 69.08)
23.54
(13.35 to 41.50)
Serotype 20B Number Analyzed 49 participants 49 participants
6.08
(3.16 to 11.71)
8.89
(5.29 to 14.95)
9.Secondary Outcome
Title GMFR From Baseline in Serotype-specific IgG GMCs
Hide Description GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Time Frame Baseline (Day 1) and Day 30 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Serotype 3 Number Analyzed 51 participants 51 participants
5.92
(4.25 to 8.24)
4.47
(3.48 to 5.74)
Serotype 7F Number Analyzed 51 participants 51 participants
23.86
(16.20 to 35.14)
10.51
(7.57 to 14.58)
Serotype 19A Number Analyzed 51 participants 51 participants
7.58
(5.51 to 10.44)
3.52
(2.71 to 4.56)
Serotype 22F Number Analyzed 51 participants 51 participants
14.68
(9.24 to 23.30)
6.57
(4.65 to 9.28)
Serotype 33F Number Analyzed 51 participants 51 participants
21.61
(14.49 to 32.23)
11.52
(8.24 to 16.13)
Serotype 8 Number Analyzed 51 participants 51 participants
31.58
(22.46 to 44.39)
16.71
(12.61 to 22.14)
Serotype 9N Number Analyzed 51 participants 51 participants
24.26
(16.60 to 35.46)
10.56
(8.01 to 13.92)
Serotype 10A Number Analyzed 51 participants 51 participants
15.70
(10.45 to 23.59)
7.19
(5.13 to 10.07)
Serotype 11A Number Analyzed 51 participants 51 participants
9.31
(6.51 to 13.31)
4.64
(3.47 to 6.22)
Serotype 12F Number Analyzed 51 participants 51 participants
23.87
(15.22 to 37.44)
6.53
(4.52 to 9.44)
Serotype 17F Number Analyzed 51 participants 51 participants
20.71
(15.14 to 28.33)
7.37
(5.60 to 9.69)
Serotype 20A Number Analyzed 51 participants 51 participants
11.68
(8.14 to 16.77)
6.19
(4.57 to 8.38)
Serotype 6A Number Analyzed 51 participants 51 participants
14.01
(8.99 to 21.86)
4.67
(3.28 to 6.63)
Serotype 15A Number Analyzed 51 participants 51 participants
32.11
(18.79 to 54.89)
3.34
(2.52 to 4.44)
Serotype 15C Number Analyzed 51 participants 51 participants
42.20
(25.71 to 69.25)
11.50
(7.83 to 16.88)
Serotype 16F Number Analyzed 51 participants 51 participants
21.00
(14.13 to 31.23)
1.52
(1.33 to 1.73)
Serotype 23A Number Analyzed 51 participants 51 participants
18.42
(12.28 to 27.63)
2.26
(1.67 to 3.06)
Serotype 23B Number Analyzed 51 participants 51 participants
14.04
(9.14 to 21.58)
3.22
(2.55 to 4.06)
Serotype 24F Number Analyzed 51 participants 51 participants
31.58
(18.26 to 54.60)
1.15
(1.01 to 1.31)
Serotype 31 Number Analyzed 51 participants 51 participants
17.97
(12.37 to 26.10)
1.64
(1.28 to 2.09)
Serotype 35B Number Analyzed 51 participants 51 participants
16.93
(11.99 to 23.90)
1.10
(1.05 to 1.15)
Serotype 6C Number Analyzed 49 participants 50 participants
5.94
(4.25 to 8.30)
2.21
(1.79 to 2.74)
Serotype 15B Number Analyzed 51 participants 51 participants
11.14
(7.39 to 16.78)
8.61
(6.14 to 12.08)
Time Frame Up to 62 days postvaccination.
Adverse Event Reporting Description The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
 
Arm/Group Title V116 PNEUMOVAX™23
Hide Arm/Group Description Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
All-Cause Mortality
V116 PNEUMOVAX™23
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/51 (0.00%)    
Hide Serious Adverse Events
V116 PNEUMOVAX™23
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      0/51 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
V116 PNEUMOVAX™23
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/51 (58.82%)      35/51 (68.63%)    
General disorders     
Fatigue † 1  7/51 (13.73%)  7 5/51 (9.80%)  5
Injection site erythema † 1  5/51 (9.80%)  5 5/51 (9.80%)  5
Injection site pain † 1  28/51 (54.90%)  28 34/51 (66.67%)  34
Injection site swelling † 1  7/51 (13.73%)  7 7/51 (13.73%)  7
Pyrexia † 1  0/51 (0.00%)  0 3/51 (5.88%)  3
Musculoskeletal and connective tissue disorders     
Myalgia † 1  9/51 (17.65%)  9 10/51 (19.61%)  10
Nervous system disorders     
Headache † 1  5/51 (9.80%)  6 5/51 (9.80%)  5
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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 will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT04665050    
Other Study ID Numbers: pPCV-002
pPCV-002 ( Other Identifier: Merck )
jRCT2071200094 ( Registry Identifier: jRCT )
V116-002 ( Other Identifier: Merck )
First Submitted: December 8, 2020
First Posted: December 11, 2020
Results First Submitted: August 4, 2022
Results First Posted: July 7, 2023
Last Update Posted: October 4, 2023