A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03547167
Collaborator
(none)
1,515
78
2
18.2
19.4
1.1
Study Details
Study Description
Brief Summary
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1515 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)
Actual Study Start Date
:
Jul 16, 2018
Actual Primary Completion Date
:
Jan 20, 2020
Actual Study Completion Date
:
Jan 20, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: V114 Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2) |
Biological: V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
Biological: PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Other Names:
|
| Active Comparator: Prevnar 13™ Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2) |
Biological: Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
Other Names:
Biological: PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ [Up to 5 days after Vaccination 1]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.
- Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ [Up to 14 days after Vaccination 1]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
- Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ [Up to Month 6 (before Vaccination 2)]
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 V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
- Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ [Day 30]
The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Secondary Outcome Measures
- Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 [Up to 5 days after Vaccination 2 (Month 6)]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
- Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 [Up to 14 days after Vaccination 2 (Month 6)]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
- Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23 [From Month 6 (before Vaccination 2) to Month 7]
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 PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
- Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 [Day 30]
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
- Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 [Day 1 (Baseline) and Day 30]
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
- GMFR in Serotype-specific IgG Day 1 to Day 30 [Day 1 (Baseline) and Day 30]
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
- Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 [Day 1 (Baseline) and Day 30]
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
- Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 [Day 1 (Baseline) and Day 30]
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
- Geometric Mean Titer of Serotype-specific OPA at Month 7 [Month 7]
The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
- Geometric Mean Concentration of Serotype-specific IgG at Month 7 [Month 7]
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
- GMFR in Serotype-specific OPA Day 1 to Month 7 [Day 1 (Baseline) and Month 7]
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
- GMFR in Serotype-specific IgG Day 1 to Month 7 [Day 1 (Baseline) and Month 7]
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
- Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 [Day 1 (Baseline) and Month 7]
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
- Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 [Day 1 (Baseline) and Month 7]
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
- GMFR in Serotype-specific OPA Month 6 to Month 7 [Month 6 (Baseline before Vaccination 2) and Month 7]
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
- GMFR in Serotype-specific IgG Month 6 to Month 7 [Month 6 (Baseline before Vaccination 2) and Month 7]
IgG for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
- Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 [Month 6 (Baseline before Vaccination 2) and Month 7]
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
- Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 [Month 6 (Baseline before Vaccination 2) and Month 7]
IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with ≥1 of the following risk conditions for pneumococcal disease:
-
Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) <10%
-
Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)
-
Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3
-
Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy
-
Confirmed diagnosis of chronic heart disease (New York Heart Association [NYHA] heart failure Class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease.
-
Current smoker
- Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine.
Exclusion Criteria:
-
History of active hepatitis within the prior 3 months
-
History of diabetic ketoacidosis, or >1 episodes of severe, symptomatic hypoglycemia within the prior 3 months
-
Myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months
-
History of severe pulmonary hypertension or history of Eisenmenger syndrome
-
History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within the prior 3 years
-
Known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine
-
Known or suspected impairment of immunological function (including human immunodeficiency virus (HIV) infection or autoimmune disease)
-
History of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
-
History of Stage 4 or 5 Chronic Kidney Disease or nephrotic syndrome
-
History of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months
-
History of coagulation disorder contraindicating intramuscular vaccination
-
History of hospitalization within the prior 3 months
-
Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study.
-
Expected survival for less than 1 year according to the investigator's judgment.
-
Female participant: positive urine or serum pregnancy test
-
Prior administration of any pneumococcal vaccine
-
Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed within the prior 30 days
-
Received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination
-
Receiving immunosuppressive or immunomodulatory therapy with a biological agent
-
Received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine
-
Received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine
-
Received a blood transfusion or blood products within the prior 6 months
-
Receiving chronic home oxygen therapy
-
Participated in another clinical study of an investigational product within the prior 2 months
-
Current user of recreational or illicit drugs or history of drug abuse or dependence
-
Diabetes mellitus with HgA1c ≥10%
-
Chronic liver disease with Child-Pugh Class B or C cirrhosis
-
Chronic lung disease with Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage 4 or severe persistent asthma
-
Chronic heart disease with NYHA heart failure Class 4.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinle Comprehensive Health Care Facility ( Site 0001) | Chinle | Arizona | United States | 86503 |
| 2 | Fort Defiance Center for American Indian Health ( Site 0002) | Fort Defiance | Arizona | United States | 86504 |
| 3 | Pulmonary Associates, PA ( Site 0043) | Glendale | Arizona | United States | 85306 |
| 4 | Central Phoenix Medical Clinic, LLC ( Site 0031) | Phoenix | Arizona | United States | 85020 |
| 5 | Whiteriver Center for American Indian Health ( Site 0005) | Whiteriver | Arizona | United States | 85941 |
| 6 | Inland Empire Clinical Trials, LLC ( Site 0052) | Rialto | California | United States | 92377 |
| 7 | Top Medical Research, Inc ( Site 0033) | Cutler Bay | Florida | United States | 33189 |
| 8 | Indago Research & Health Center, Inc ( Site 0054) | Hialeah | Florida | United States | 33012 |
| 9 | Renstar Medical Research ( Site 0008) | Ocala | Florida | United States | 34471 |
| 10 | Triple O Research Institute, P.A. ( Site 0026) | West Palm Beach | Florida | United States | 33407 |
| 11 | Emory University School of Medicine at Grady Hospital ( Site 0027) | Atlanta | Georgia | United States | 30303 |
| 12 | Kootenai Health ( Site 0042) | Coeur d'Alene | Idaho | United States | 83814 |
| 13 | Evanston Premier Healthcare & Research, LLC. ( Site 0012) | Evanston | Illinois | United States | 60201 |
| 14 | Pharmakon Inc ( Site 0049) | Evergreen Park | Illinois | United States | 60805 |
| 15 | Reid Physician Associates ( Site 0055) | Richmond | Indiana | United States | 47374 |
| 16 | The Center for Pharmaceutical Research PC ( Site 0050) | Kansas City | Missouri | United States | 64114 |
| 17 | Clinical Research Consortium ( Site 0053) | Las Vegas | Nevada | United States | 89119 |
| 18 | Internal Medicine Associates [Bridgeton, NJ] ( Site 0015) | Bridgeton | New Jersey | United States | 08302 |
| 19 | Gallup Center for American Indian Health ( Site 0003) | Gallup | New Mexico | United States | 87301 |
| 20 | Shiprock Center for American Indian Health ( Site 0004) | Shiprock | New Mexico | United States | 87420 |
| 21 | Corning Center For Clinical Research ( Site 0036) | Corning | New York | United States | 14830 |
| 22 | Mid Hudson Medical Research ( Site 0022) | New Windsor | New York | United States | 12553 |
| 23 | Wake Research Associates, LLC ( Site 0016) | Raleigh | North Carolina | United States | 27612 |
| 24 | Lehigh Valley Health Network ( Site 0040) | Allentown | Pennsylvania | United States | 18102 |
| 25 | University of Pennsylvania ( Site 0030) | Philadelphia | Pennsylvania | United States | 19104 |
| 26 | Mountain View Clinical Research ( Site 0007) | Greer | South Carolina | United States | 29651 |
| 27 | Holston Medical Group ( Site 0025) | Kingsport | Tennessee | United States | 37660 |
| 28 | AIM Trials ( Site 0060) | Fort Worth | Texas | United States | 76104 |
| 29 | University of Texas Medical Branch at Galveston ( Site 0034) | Galveston | Texas | United States | 77555-1115 |
| 30 | Private Practice Leadership, LLC ( Site 0051) | Houston | Texas | United States | 77094 |
| 31 | Texas Center For Drug Development ( Site 0041) | Houston | Texas | United States | 77801 |
| 32 | Texas Institute Of Cardiology ( Site 0048) | McKinney | Texas | United States | 75071 |
| 33 | Village Health Partners ( Site 0006) | Plano | Texas | United States | 75024 |
| 34 | Copperview Medical Center ( Site 0038) | South Jordan | Utah | United States | 84095 |
| 35 | Timber Lane Allergy & Asthma Research, LLC ( Site 0044) | South Burlington | Vermont | United States | 05403 |
| 36 | Pulmonary & Sleep Research ( Site 0046) | Spokane Valley | Washington | United States | 99216 |
| 37 | Gundersen Health System ( Site 0021) | La Crosse | Wisconsin | United States | 54601 |
| 38 | Marshfield Clinic ( Site 0013) | Marshfield | Wisconsin | United States | 54449 |
| 39 | Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174) | Blacktown | New South Wales | Australia | 2148 |
| 40 | Holdsworth House Medical Practice ( Site 0170) | Sydney | New South Wales | Australia | 2010 |
| 41 | Core Research Group Pty limited ( Site 0175) | Brisbane | Queensland | Australia | 4064 |
| 42 | Emeritus Research Pty Ltd ( Site 0173) | Camberwell | Victoria | Australia | 3124 |
| 43 | Paratus Clinical Kanwal ( Site 0172) | Kanwal | Australia | 2259 | |
| 44 | Nepean Hospital ( Site 0176) | Kingswood | Australia | 2747 | |
| 45 | The Liver and Intestinal Research Centre (LAIR) ( Site 0302) | Vancouver | British Columbia | Canada | V5Z 1H2 |
| 46 | GA Research Associates, Ltd/Ltee ( Site 0303) | Moncton | New Brunswick | Canada | E1G 1A7 |
| 47 | Colchester Research Group ( Site 0094) | Truro | Nova Scotia | Canada | B2N 1L2 |
| 48 | Hamilton Medical Research Group ( Site 0092) | Hamilton | Ontario | Canada | L8M 1K7 |
| 49 | SKDS Research Inc. ( Site 0099) | Newmarket | Ontario | Canada | L3Y 5G8 |
| 50 | Omnispec Recherche Clinique Inc ( Site 0093) | Mirabel | Quebec | Canada | J7J 2K8 |
| 51 | Dynamik Research ( Site 0095) | Pointe-Claire | Quebec | Canada | H9R 3J1 |
| 52 | Q & T Research Sherbrooke Inc. ( Site 0097) | Sherbrooke | Quebec | Canada | J1J 2G2 |
| 53 | Diex Recherche Quebec Inc ( Site 0091) | Quebec | Canada | G1N 4V3 | |
| 54 | Clinica Arauco Salud ( Site 0100) | Santiago | RM | Chile | 7560994 |
| 55 | Centro de Investigacion Clinica UC CICUC ( Site 0104) | Santiago | Chile | 8330034 | |
| 56 | CECIM ( Site 0101) | Santiago | Chile | 8330336 | |
| 57 | CESFAM Esmeralda ( Site 0102) | Santiago | Chile | 9351603 | |
| 58 | Hospital Dr. Hernan Henriquez Aravena ( Site 0105) | Temuco | Chile | 4781151 | |
| 59 | Southern Clinical Trials - Waitemata ( Site 0183) | Auckland | New Zealand | 0626 | |
| 60 | Auckland Clinical Studies Limited ( Site 0189) | Auckland | New Zealand | 1010 | |
| 61 | Optimal Clinical Trials ( Site 0182) | Auckland | New Zealand | 1010 | |
| 62 | Christchurch Heart Institute ( Site 0280) | Christchurch | New Zealand | 8011 | |
| 63 | Southern Clinical Trials Ltd ( Site 0180) | Christchurch | New Zealand | 8013 | |
| 64 | Lakeland Clinical Trials ( Site 0181) | Rotorua | New Zealand | 3010 | |
| 65 | Bay of Plenty Clinical School ( Site 0186) | Tauranga | New Zealand | 3143 | |
| 66 | P3 Research Ltd - Wellington ( Site 0184) | Wellington | New Zealand | 6021 | |
| 67 | WSOZ im.T.Browicza w Bydgoszczy ( Site 0317) | Bydgoszcz | Poland | 85-030 | |
| 68 | Centrum Medyczne Pratia Bydgoszcz ( Site 0139) | Bydgoszcz | Poland | 85-796 | |
| 69 | Synexus Polska Sp. z o.o. ( Site 0238) | Gdansk | Poland | 80-382 | |
| 70 | Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233) | Krakow | Poland | 30-033 | |
| 71 | ID Clinic ( Site 0235) | Myslowice | Poland | 41-400 | |
| 72 | Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319) | Skierniewice | Poland | 96-100 | |
| 73 | Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314) | Sopot | Poland | 81-717 | |
| 74 | Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236) | Wroclaw | Poland | 50-136 | |
| 75 | Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234) | Wroclaw | Poland | 50-381 | |
| 76 | Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249) | Kazan | Russian Federation | 420140 | |
| 77 | Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144) | Saratov | Russian Federation | 410054 | |
| 78 | Smolensk State Medical University ( Site 0246) | Smolensk | Russian Federation | 214019 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT03547167
Other Study ID Numbers:
- V114-017
- 2017-004915-38
- V114-017
First Posted:
Jun 6, 2018
Last Update Posted:
Jan 15, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Period Title: Overall Study | ||
| STARTED | 1135 | 380 |
| Vaccination 1 - (V114 or Prevnar 13™, Day 1) | 1133 | 379 |
| Vaccination 2 - (PNEUMOVAX™23, Month 6) | 1035 | 346 |
| COMPLETED | 1038 | 350 |
| NOT COMPLETED | 97 | 30 |
Baseline Characteristics
| Arm/Group Title | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Arm/Group Description | Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Total of all reporting groups |
| Overall Participants | 1135 | 380 | 1515 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
35.9
(8.9)
|
35.8
(8.9)
|
35.8
(8.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
581
51.2%
|
201
52.9%
|
782
51.6%
|
| Male |
554
48.8%
|
179
47.1%
|
733
48.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
135
11.9%
|
39
10.3%
|
174
11.5%
|
| Not Hispanic or Latino |
984
86.7%
|
338
88.9%
|
1322
87.3%
|
| Unknown or Not Reported |
16
1.4%
|
3
0.8%
|
19
1.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
445
39.2%
|
148
38.9%
|
593
39.1%
|
| Asian |
15
1.3%
|
8
2.1%
|
23
1.5%
|
| Native Hawaiian or Other Pacific Islander |
33
2.9%
|
11
2.9%
|
44
2.9%
|
| Black or African American |
43
3.8%
|
18
4.7%
|
61
4%
|
| White |
582
51.3%
|
192
50.5%
|
774
51.1%
|
| More than one race |
17
1.5%
|
3
0.8%
|
20
1.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ |
|---|---|
| Description | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Time Frame | Up to 5 days after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1134 | 378 |
| Injection site redness/erythema |
15.1
1.3%
|
14.0
3.7%
|
| Injection site tenderness/pain |
75.8
6.7%
|
68.8
18.1%
|
| Injection site swelling |
21.7
1.9%
|
22.2
5.8%
|
| Title | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ |
|---|---|
| Description | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Time Frame | Up to 14 days after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1134 | 378 |
| Joint pain/arthralgia |
12.7
1.1%
|
11.6
3.1%
|
| Tiredness/fatigue |
34.3
3%
|
36.8
9.7%
|
| Headache |
26.5
2.3%
|
24.9
6.6%
|
| Muscle pain/myalgia |
28.8
2.5%
|
25.5
6.7%
|
| Title | Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ |
|---|---|
| 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 V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Time Frame | Up to Month 6 (before Vaccination 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1134 | 378 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
| Title | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ |
|---|---|
| Description | The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Time Frame | Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
268.6
|
267.2
|
| Serotype 3 (Shared) |
199.3
|
150.6
|
| Serotype 4 (Shared) |
1416.0
|
2576.1
|
| Serotype 5 (Shared) |
564.8
|
731.1
|
| Serotype 6A (Shared) |
12928.8
|
11282.4
|
| Serotype 6B (Shared) |
10336.9
|
6995.7
|
| Serotype 7F (Shared) |
5756.4
|
7588.9
|
| Serotype 9V (Shared) |
3355.1
|
3983.7
|
| Serotype 14 (Shared) |
5228.9
|
5889.8
|
| Serotype 18C (Shared) |
5709.0
|
3063.2
|
| Serotype 19A (Shared) |
5369.9
|
5888.0
|
| Serotype 19F (Shared) |
3266.3
|
3272.7
|
| Serotype 23F (Shared) |
4853.5
|
3887.3
|
| Serotype 22F (Unique to V114) |
3926.5
|
291.6
|
| Serotype 33F (Unique to V114) |
11627.8
|
2180.6
|
| Title | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 |
|---|---|
| Description | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. |
| Time Frame | Up to 5 days after Vaccination 2 (Month 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1036 | 345 |
| Injection site redness/erythema |
22.6
2%
|
25.5
6.7%
|
| Injection site tenderness/pain |
68.8
6.1%
|
67.0
17.6%
|
| Injection site swelling |
29.4
2.6%
|
32.2
8.5%
|
| Title | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 |
|---|---|
| Description | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Time Frame | Up to 14 days after Vaccination 2 (Month 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1036 | 345 |
| Joint pain/arthralgia |
12.0
1.1%
|
11.0
2.9%
|
| Tiredness/fatigue |
30.1
2.7%
|
30.7
8.1%
|
| Headache |
21.2
1.9%
|
21.2
5.6%
|
| Muscle pain/myalgia |
24.1
2.1%
|
25.5
6.7%
|
| Title | Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23 |
|---|---|
| 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 PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Time Frame | From Month 6 (before Vaccination 2) to Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1036 | 345 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0.0
0%
|
0.3
0.1%
|
| Title | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 |
|---|---|
| Description | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Time Frame | Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
3.56
|
4.59
|
| Serotype 3 (Shared) |
0.77
|
0.63
|
| Serotype 4 (Shared) |
1.53
|
2.71
|
| Serotype 5 (Shared) |
3.43
|
4.48
|
| Serotype 6A (Shared) |
11.84
|
10.87
|
| Serotype 6B (Shared) |
17.90
|
11.36
|
| Serotype 7F (Shared) |
5.18
|
6.88
|
| Serotype 9V (Shared) |
4.44
|
5.31
|
| Serotype 14 (Shared) |
15.91
|
17.35
|
| Serotype 18C (Shared) |
14.57
|
9.32
|
| Serotype 19A (Shared) |
19.41
|
21.79
|
| Serotype 19F (Shared) |
13.98
|
13.35
|
| Serotype 23F (Shared) |
13.57
|
10.98
|
| Serotype 22F (Unique to V114) |
6.22
|
0.52
|
| Serotype 33F (Unique to V114) |
7.79
|
0.88
|
| Title | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 |
|---|---|
| Description | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
22.8
|
21.9
|
| Serotype 3 (Shared) |
5.8
|
4.8
|
| Serotype 4 (Shared) |
17.9
|
33.4
|
| Serotype 5 (Shared) |
17.3
|
21.1
|
| Serotype 6A (Shared) |
21.7
|
21.4
|
| Serotype 6B (Shared) |
32.2
|
25.0
|
| Serotype 7F (Shared) |
7.3
|
10.0
|
| Serotype 9V (Shared) |
4.9
|
5.7
|
| Serotype 14 (Shared) |
8.2
|
8.7
|
| Serotype 18C (Shared) |
20.4
|
11.7
|
| Serotype 19A (Shared) |
12.5
|
13.6
|
| Serotype 19F (Shared) |
7.5
|
7.4
|
| Serotype 23F (Shared) |
22.5
|
17.8
|
| Serotype 22F (Unique to V114) |
13.9
|
1.3
|
| Serotype 33F (Unique to V114) |
5.4
|
1.0
|
| Title | GMFR in Serotype-specific IgG Day 1 to Day 30 |
|---|---|
| Description | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
12.2
|
15.7
|
| Serotype 3 (Shared) |
4.1
|
3.6
|
| Serotype 4 (Shared) |
8.0
|
16.2
|
| Serotype 5 (Shared) |
4.3
|
5.2
|
| Serotype 6A (Shared) |
35.5
|
31.3
|
| Serotype 6B (Shared) |
40.5
|
28.0
|
| Serotype 7F (Shared) |
12.2
|
16.9
|
| Serotype 9V (Shared) |
10.6
|
12.8
|
| Serotype 14 (Shared) |
11.3
|
11.5
|
| Serotype 18C (Shared) |
30.5
|
20.0
|
| Serotype 19A (Shared) |
11.1
|
14.0
|
| Serotype 19F (Shared) |
14.4
|
15.3
|
| Serotype 23F (Shared) |
26.5
|
22.0
|
| Serotype 22F (Unique to V114) |
11.4
|
1.0
|
| Serotype 33F (Unique to V114) |
8.3
|
1.0
|
| Title | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 |
|---|---|
| Description | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
83.9
7.4%
|
81.4
21.4%
|
| Serotype 3 (Shared) |
62.2
5.5%
|
56.8
14.9%
|
| Serotype 4 (Shared) |
79.0
7%
|
87.8
23.1%
|
| Serotype 5 (Shared) |
83.4
7.3%
|
84.9
22.3%
|
| Serotype 6A (Shared) |
87.5
7.7%
|
85.2
22.4%
|
| Serotype 6B (Shared) |
84.7
7.5%
|
83.8
22.1%
|
| Serotype 7F (Shared) |
56.8
5%
|
64.5
17%
|
| Serotype 9V (Shared) |
51.5
4.5%
|
55.4
14.6%
|
| Serotype 14 (Shared) |
59.8
5.3%
|
60.4
15.9%
|
| Serotype 18C (Shared) |
84.5
7.4%
|
75.8
19.9%
|
| Serotype 19A (Shared) |
72.1
6.4%
|
75.2
19.8%
|
| Serotype 19F (Shared) |
64.3
5.7%
|
65.7
17.3%
|
| Serotype 23F (Shared) |
78.7
6.9%
|
77.7
20.4%
|
| Serotype 22F (Unique to V114) |
58.9
5.2%
|
15.5
4.1%
|
| Serotype 33F (Unique to V114) |
52.9
4.7%
|
3.1
0.8%
|
| Title | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 |
|---|---|
| Description | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
81.2
7.2%
|
86.4
22.7%
|
| Serotype 3 (Shared) |
44.8
3.9%
|
41.1
10.8%
|
| Serotype 4 (Shared) |
70.1
6.2%
|
86.1
22.7%
|
| Serotype 5 (Shared) |
44.1
3.9%
|
50.4
13.3%
|
| Serotype 6A (Shared) |
93.3
8.2%
|
88.2
23.2%
|
| Serotype 6B (Shared) |
93.4
8.2%
|
90.5
23.8%
|
| Serotype 7F (Shared) |
79.3
7%
|
86.4
22.7%
|
| Serotype 9V (Shared) |
76.5
6.7%
|
84.0
22.1%
|
| Serotype 14 (Shared) |
70.8
6.2%
|
68.6
18.1%
|
| Serotype 18C (Shared) |
91.1
8%
|
87.3
23%
|
| Serotype 19A (Shared) |
75.3
6.6%
|
82.0
21.6%
|
| Serotype 19F (Shared) |
80.0
7%
|
80.8
21.3%
|
| Serotype 23F (Shared) |
89.2
7.9%
|
87.6
23.1%
|
| Serotype 22F (Unique to V114) |
73.1
6.4%
|
1.5
0.4%
|
| Serotype 33F (Unique to V114) |
70.0
6.2%
|
0.3
0.1%
|
| Title | Geometric Mean Titer of Serotype-specific OPA at Month 7 |
|---|---|
| Description | The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Time Frame | Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
266.6
|
214.4
|
| Serotype 3 (Shared) |
211.0
|
208.0
|
| Serotype 4 (Shared) |
1734.5
|
1980.6
|
| Serotype 5 (Shared) |
595.1
|
626.7
|
| Serotype 6A (Shared) |
5810.3
|
5739.9
|
| Serotype 6B (Shared) |
5215.2
|
4412.4
|
| Serotype 7F (Shared) |
6070.5
|
6223.9
|
| Serotype 9V (Shared) |
3133.1
|
3364.1
|
| Serotype 14 (Shared) |
5644.9
|
5317.6
|
| Serotype 18C (Shared) |
3260.6
|
2294.4
|
| Serotype 19A (Shared) |
4336.2
|
4286.4
|
| Serotype 19F (Shared) |
3198.6
|
3085.4
|
| Serotype 23F (Shared) |
3057.3
|
2896.0
|
| Serotype 22F (Unique to V114) |
3624.0
|
4060.2
|
| Serotype 33F (Unique to V114) |
11356.6
|
16053.2
|
| Title | Geometric Mean Concentration of Serotype-specific IgG at Month 7 |
|---|---|
| Description | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. |
| Time Frame | Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
2.91
|
3.42
|
| Serotype 3 (Shared) |
0.66
|
0.68
|
| Serotype 4 (Shared) |
1.33
|
1.77
|
| Serotype 5 (Shared) |
3.45
|
3.92
|
| Serotype 6A (Shared) |
4.25
|
4.88
|
| Serotype 6B (Shared) |
6.79
|
6.04
|
| Serotype 7F (Shared) |
3.46
|
4.07
|
| Serotype 9V (Shared) |
3.18
|
3.61
|
| Serotype 14 (Shared) |
14.28
|
14.59
|
| Serotype 18C (Shared) |
5.50
|
4.24
|
| Serotype 19A (Shared) |
11.26
|
12.04
|
| Serotype 19F (Shared) |
9.07
|
8.81
|
| Serotype 23F (Shared) |
5.42
|
4.96
|
| Serotype 22F (Unique to V114) |
4.85
|
4.76
|
| Serotype 33F (Unique to V114) |
5.98
|
8.66
|
| Title | GMFR in Serotype-specific OPA Day 1 to Month 7 |
|---|---|
| Description | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
22.6
|
17.4
|
| Serotype 3 (Shared) |
6.1
|
6.4
|
| Serotype 4 (Shared) |
21.6
|
25.6
|
| Serotype 5 (Shared) |
17.8
|
18.3
|
| Serotype 6A (Shared) |
9.6
|
11.0
|
| Serotype 6B (Shared) |
16.6
|
15.7
|
| Serotype 7F (Shared) |
7.7
|
8.2
|
| Serotype 9V (Shared) |
4.5
|
4.9
|
| Serotype 14 (Shared) |
9.2
|
8.0
|
| Serotype 18C (Shared) |
11.1
|
9.1
|
| Serotype 19A (Shared) |
9.6
|
9.7
|
| Serotype 19F (Shared) |
6.9
|
7.1
|
| Serotype 23F (Shared) |
14.0
|
12.6
|
| Serotype 22F (Unique to V114) |
12.1
|
16.6
|
| Serotype 33F (Unique to V114) |
5.1
|
6.6
|
| Title | GMFR in Serotype-specific IgG Day 1 to Month 7 |
|---|---|
| Description | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
10.1
|
11.4
|
| Serotype 3 (Shared) |
3.5
|
3.8
|
| Serotype 4 (Shared) |
7.1
|
10.7
|
| Serotype 5 (Shared) |
4.3
|
4.6
|
| Serotype 6A (Shared) |
12.3
|
13.9
|
| Serotype 6B (Shared) |
15.3
|
14.9
|
| Serotype 7F (Shared) |
8.7
|
10.1
|
| Serotype 9V (Shared) |
7.6
|
8.5
|
| Serotype 14 (Shared) |
10.3
|
10.0
|
| Serotype 18C (Shared) |
11.5
|
9.3
|
| Serotype 19A (Shared) |
6.4
|
7.5
|
| Serotype 19F (Shared) |
9.0
|
9.8
|
| Serotype 23F (Shared) |
10.8
|
10.3
|
| Serotype 22F (Unique to V114) |
8.9
|
8.9
|
| Serotype 33F (Unique to V114) |
6.4
|
9.6
|
| Title | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 |
|---|---|
| Description | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
87.7
7.7%
|
83.7
22%
|
| Serotype 3 (Shared) |
66.5
5.9%
|
66.7
17.6%
|
| Serotype 4 (Shared) |
84.3
7.4%
|
86.4
22.7%
|
| Serotype 5 (Shared) |
86.8
7.6%
|
87.1
22.9%
|
| Serotype 6A (Shared) |
73.5
6.5%
|
80.2
21.1%
|
| Serotype 6B (Shared) |
75.8
6.7%
|
74.4
19.6%
|
| Serotype 7F (Shared) |
59.8
5.3%
|
60.2
15.8%
|
| Serotype 9V (Shared) |
50.5
4.4%
|
52.4
13.8%
|
| Serotype 14 (Shared) |
64.9
5.7%
|
58.9
15.5%
|
| Serotype 18C (Shared) |
77.5
6.8%
|
76.2
20.1%
|
| Serotype 19A (Shared) |
68.2
6%
|
70.5
18.6%
|
| Serotype 19F (Shared) |
61.0
5.4%
|
62.9
16.6%
|
| Serotype 23F (Shared) |
73.5
6.5%
|
71.9
18.9%
|
| Serotype 22F (Unique to V114) |
59.0
5.2%
|
65.4
17.2%
|
| Serotype 33F (Unique to V114) |
53.3
4.7%
|
60.8
16%
|
| Title | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 |
|---|---|
| Description | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| Time Frame | Day 1 (Baseline) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
81.4
7.2%
|
83.6
22%
|
| Serotype 3 (Shared) |
40.7
3.6%
|
46.1
12.1%
|
| Serotype 4 (Shared) |
71.2
6.3%
|
82.0
21.6%
|
| Serotype 5 (Shared) |
48.7
4.3%
|
51.8
13.6%
|
| Serotype 6A (Shared) |
81.6
7.2%
|
81.8
21.5%
|
| Serotype 6B (Shared) |
86.4
7.6%
|
85.4
22.5%
|
| Serotype 7F (Shared) |
77.4
6.8%
|
84.3
22.2%
|
| Serotype 9V (Shared) |
71.8
6.3%
|
77.1
20.3%
|
| Serotype 14 (Shared) |
76.7
6.8%
|
70.7
18.6%
|
| Serotype 18C (Shared) |
82.7
7.3%
|
80.4
21.2%
|
| Serotype 19A (Shared) |
65.8
5.8%
|
74.6
19.6%
|
| Serotype 19F (Shared) |
74.5
6.6%
|
78.9
20.8%
|
| Serotype 23F (Shared) |
77.8
6.9%
|
78.1
20.6%
|
| Serotype 22F (Unique to V114) |
68.8
6.1%
|
65.7
17.3%
|
| Serotype 33F (Unique to V114) |
68.2
6%
|
75.7
19.9%
|
| Title | GMFR in Serotype-specific OPA Month 6 to Month 7 |
|---|---|
| Description | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| Time Frame | Month 6 (Baseline before Vaccination 2) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
3.2
|
2.0
|
| Serotype 3 (Shared) |
2.0
|
2.4
|
| Serotype 4 (Shared) |
2.7
|
1.7
|
| Serotype 5 (Shared) |
2.7
|
2.1
|
| Serotype 6A (Shared) |
1.0
|
1.1
|
| Serotype 6B (Shared) |
1.1
|
1.2
|
| Serotype 7F (Shared) |
1.9
|
1.4
|
| Serotype 9V (Shared) |
1.6
|
1.5
|
| Serotype 14 (Shared) |
2.0
|
1.5
|
| Serotype 18C (Shared) |
1.3
|
1.6
|
| Serotype 19A (Shared) |
1.7
|
1.5
|
| Serotype 19F (Shared) |
1.9
|
1.6
|
| Serotype 23F (Shared) |
1.3
|
1.4
|
| Serotype 22F (Unique to V114) |
1.8
|
9.6
|
| Serotype 33F (Unique to V114) |
1.6
|
6.5
|
| Title | GMFR in Serotype-specific IgG Month 6 to Month 7 |
|---|---|
| Description | IgG for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Time Frame | Month 6 (Baseline before Vaccination 2) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
2.1
|
1.5
|
| Serotype 3 (Shared) |
1.7
|
2.0
|
| Serotype 4 (Shared) |
2.0
|
1.6
|
| Serotype 5 (Shared) |
1.9
|
1.5
|
| Serotype 6A (Shared) |
1.0
|
1.0
|
| Serotype 6B (Shared) |
1.1
|
1.2
|
| Serotype 7F (Shared) |
1.7
|
1.4
|
| Serotype 9V (Shared) |
1.5
|
1.4
|
| Serotype 14 (Shared) |
1.7
|
1.4
|
| Serotype 18C (Shared) |
1.1
|
1.1
|
| Serotype 19A (Shared) |
1.4
|
1.4
|
| Serotype 19F (Shared) |
1.6
|
1.6
|
| Serotype 23F (Shared) |
1.1
|
1.2
|
| Serotype 22F (Unique to V114) |
1.8
|
8.8
|
| Serotype 33F (Unique to V114) |
1.6
|
9.9
|
| Title | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 |
|---|---|
| Description | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Time Frame | Month 6 (Baseline before Vaccination 2) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
40.2
3.5%
|
21.4
5.6%
|
| Serotype 3 (Shared) |
19.2
1.7%
|
25.5
6.7%
|
| Serotype 4 (Shared) |
30.8
2.7%
|
14.9
3.9%
|
| Serotype 5 (Shared) |
32.5
2.9%
|
23.0
6.1%
|
| Serotype 6A (Shared) |
3.9
0.3%
|
5.9
1.6%
|
| Serotype 6B (Shared) |
4.6
0.4%
|
6.4
1.7%
|
| Serotype 7F (Shared) |
14.6
1.3%
|
7.5
2%
|
| Serotype 9V (Shared) |
11.9
1%
|
10.4
2.7%
|
| Serotype 14 (Shared) |
17.8
1.6%
|
8.6
2.3%
|
| Serotype 18C (Shared) |
5.4
0.5%
|
14.3
3.8%
|
| Serotype 19A (Shared) |
15.9
1.4%
|
12.1
3.2%
|
| Serotype 19F (Shared) |
17.7
1.6%
|
12.9
3.4%
|
| Serotype 23F (Shared) |
9.2
0.8%
|
11.4
3%
|
| Serotype 22F (Unique to V114) |
16.7
1.5%
|
52.6
13.8%
|
| Serotype 33F (Unique to V114) |
15.8
1.4%
|
62.6
16.5%
|
| Title | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 |
|---|---|
| Description | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| Time Frame | Month 6 (Baseline before Vaccination 2) and Month 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. |
| Arm/Group Title | V114 | Prevnar 13™ |
|---|---|---|
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). |
| Measure Participants | 1133 | 379 |
| Serotype 1 (Shared) |
16.4
1.4%
|
8.2
2.2%
|
| Serotype 3 (Shared) |
6.3
0.6%
|
13.8
3.6%
|
| Serotype 4 (Shared) |
15.2
1.3%
|
7.5
2%
|
| Serotype 5 (Shared) |
12.1
1.1%
|
5.7
1.5%
|
| Serotype 6A (Shared) |
0.6
0.1%
|
1.1
0.3%
|
| Serotype 6B (Shared) |
0.7
0.1%
|
2.8
0.7%
|
| Serotype 7F (Shared) |
8.4
0.7%
|
4.3
1.1%
|
| Serotype 9V (Shared) |
6.3
0.6%
|
3.9
1%
|
| Serotype 14 (Shared) |
9.8
0.9%
|
3.9
1%
|
| Serotype 18C (Shared) |
0.6
0.1%
|
0.7
0.2%
|
| Serotype 19A (Shared) |
3.4
0.3%
|
4.3
1.1%
|
| Serotype 19F (Shared) |
8.1
0.7%
|
6.4
1.7%
|
| Serotype 23F (Shared) |
0.5
0%
|
1.1
0.3%
|
| Serotype 22F (Unique to V114) |
10.2
0.9%
|
64.9
17.1%
|
| Serotype 33F (Unique to V114) |
7.5
0.7%
|
75.9
20%
|
Adverse Events
| Time Frame | Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses. | |||||||
| Arm/Group Title | V114 | Prevnar 13™ | V114 (Post-PNEUMOVAX™23) | Prevnar 13™ (Post-PNEUMOVAX™23) | ||||
| Arm/Group Description | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2). | ||||
All Cause Mortality |
||||||||
| V114 | Prevnar 13™ | V114 (Post-PNEUMOVAX™23) | Prevnar 13™ (Post-PNEUMOVAX™23) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/1134 (0.4%) | 2/378 (0.5%) | 0/1036 (0%) | 0/345 (0%) | ||||
Serious Adverse Events |
||||||||
| V114 | Prevnar 13™ | V114 (Post-PNEUMOVAX™23) | Prevnar 13™ (Post-PNEUMOVAX™23) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 49/1134 (4.3%) | 12/378 (3.2%) | 3/1036 (0.3%) | 3/345 (0.9%) | ||||
| Cardiac disorders | ||||||||
| Angina unstable | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Cardiac failure | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Cardiovascular insufficiency | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Congestive cardiomyopathy | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pulseless electrical activity | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Acute left ventricular failure | 0/1134 (0%) | 0 | 0/378 (0%) | 0 | 1/1036 (0.1%) | 1 | 0/345 (0%) | 0 |
| Cardiac Arrest | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Endocrine disorders | ||||||||
| Diabetes insipidus | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Goitre | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Ascites | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Gastric ulcer haemorrhage | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Gastric ulcer perforation | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Inguinal hernia | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Large intestine perforation | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Obstructive pancreatitis | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pancreatitis acute | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| General disorders | ||||||||
| Chest pain | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 1/345 (0.3%) | 1 |
| Non-cardiac chest pain | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Bile duct stone | 1/1134 (0.1%) | 1 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Cholecystitis | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Cholecystitis acute | 2/1134 (0.2%) | 2 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Cholelithiasis | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Immune system disorders | ||||||||
| Anaphylactic reaction | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Infections and infestations | ||||||||
| Diverticulitis | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Gastroenteritis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Groin abscess | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Haematoma infection | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Influenza | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Localised infection | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Meningitis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Periorbital cellulitis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Perirectal abscess | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Peritonsillitis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pharyngitis streptococcal | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pneumonia | 1/1134 (0.1%) | 1 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Postoperative wound infection | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pyelonephritis | 2/1134 (0.2%) | 2 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Sepsis | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Clavicle fracture | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Eyelid injury | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Facial bones fracture | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Hand fracture | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Multiple injuries | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Skin laceration | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Tibia fracture | 1/1134 (0.1%) | 2 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Craniocerebral injury | 0/1134 (0%) | 0 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 1/345 (0.3%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Hypoglycaemia | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Rheumatoid arthritis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Colon cancer | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Endometrial cancer | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Gastrointestinal neoplasm | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Uterine leiomyoma | 2/1134 (0.2%) | 2 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Nervous system disorders | ||||||||
| Cerebrovascular accident | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Haemorrhagic stroke | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Hepatic encephalopathy | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| IIIrd nerve paralysis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Migraine | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Subarachnoid haemorrhage | 3/1134 (0.3%) | 3 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Generalised tonic-clonic seizure | 0/1134 (0%) | 0 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 1/345 (0.3%) | 1 |
| Syncope | 0/1134 (0%) | 0 | 0/378 (0%) | 0 | 1/1036 (0.1%) | 1 | 0/345 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Alcohol withdrawal syndrome | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 1/1036 (0.1%) | 1 | 0/345 (0%) | 0 |
| Completed suicide | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Drug dependence | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Suicidal ideation | 0/1134 (0%) | 0 | 1/378 (0.3%) | 1 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Suicide attempt | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 2/1134 (0.2%) | 2 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Nephrolithiasis | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Nephrotic syndrome | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Pelvic pain | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 2/1134 (0.2%) | 2 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pleuritic pain | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pneumonia aspiration | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Pulmonary embolism | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Social circumstances | ||||||||
| Physical assault | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertensive urgency | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
| Hypotension | 1/1134 (0.1%) | 1 | 0/378 (0%) | 0 | 0/1036 (0%) | 0 | 0/345 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| V114 | Prevnar 13™ | V114 (Post-PNEUMOVAX™23) | Prevnar 13™ (Post-PNEUMOVAX™23) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 934/1134 (82.4%) | 298/378 (78.8%) | 771/1036 (74.4%) | 258/345 (74.8%) | ||||
| General disorders | ||||||||
| Fatigue | 389/1134 (34.3%) | 510 | 139/378 (36.8%) | 186 | 312/1036 (30.1%) | 366 | 106/345 (30.7%) | 139 |
| Injection site erythema | 174/1134 (15.3%) | 180 | 56/378 (14.8%) | 57 | 235/1036 (22.7%) | 237 | 88/345 (25.5%) | 91 |
| Injection site pain | 865/1134 (76.3%) | 931 | 260/378 (68.8%) | 292 | 714/1036 (68.9%) | 762 | 231/345 (67%) | 252 |
| Injection site swelling | 251/1134 (22.1%) | 257 | 84/378 (22.2%) | 84 | 305/1036 (29.4%) | 307 | 113/345 (32.8%) | 113 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 144/1134 (12.7%) | 180 | 44/378 (11.6%) | 63 | 124/1036 (12%) | 130 | 38/345 (11%) | 47 |
| Myalgia | 327/1134 (28.8%) | 377 | 100/378 (26.5%) | 113 | 250/1036 (24.1%) | 260 | 88/345 (25.5%) | 99 |
| Nervous system disorders | ||||||||
| Headache | 300/1134 (26.5%) | 425 | 94/378 (24.9%) | 122 | 220/1036 (21.2%) | 274 | 73/345 (21.2%) | 93 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT03547167
Other Study ID Numbers:
- V114-017
- 2017-004915-38
- V114-017
First Posted:
Jun 6, 2018
Last Update Posted:
Jan 15, 2021
Last Verified:
Dec 1, 2020