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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: V114; Biological: PNEUMOVAX™23; Biological: Prevnar 13™

• Study Type: Interventional
• Enrollment (Actual): 1515
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Kanwal, Australia, 2259
    • Paratus Clinical Kanwal ( Site 0172)
  • Kingswood, Australia, 2747
    • Nepean Hospital ( Site 0176)
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174)
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice ( Site 0170)
  • Queensland
    • Brisbane, Queensland, Australia, 4064
      • Core Research Group Pty limited ( Site 0175)
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research Pty Ltd ( Site 0173)
• Canada
  • Quebec, Canada, G1N 4V3
    • Diex Recherche Quebec Inc ( Site 0091)
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1H2
      • The Liver and Intestinal Research Centre (LAIR) ( Site 0302)
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • GA Research Associates, Ltd/Ltee ( Site 0303)
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • Colchester Research Group ( Site 0094)
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Medical Research Group ( Site 0092)
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc. ( Site 0099)
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Omnispec Recherche Clinique Inc ( Site 0093)
    • Pointe-Claire, Quebec, Canada, H9R 3J1
      • Dynamik Research ( Site 0095)
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • Q & T Research Sherbrooke Inc. ( Site 0097)
• Chile
  • Santiago, Chile, 8330034
    • Centro de Investigacion Clinica UC CICUC ( Site 0104)
  • Santiago, Chile, 8330336
    • CECIM ( Site 0101)
  • Santiago, Chile, 9351603
    • CESFAM Esmeralda ( Site 0102)
  • Temuco, Chile, 4781151
    • Hospital Dr. Hernan Henriquez Aravena ( Site 0105)
  • RM
    • Santiago, RM, Chile, 7560994
      • Clinica Arauco Salud ( Site 0100)
• New Zealand
  • Auckland, New Zealand, 0626
    • Southern Clinical Trials - Waitemata ( Site 0183)
  • Auckland, New Zealand, 1010
    • Auckland Clinical Studies Limited ( Site 0189)
  • Auckland, New Zealand, 1010
    • Optimal Clinical Trials ( Site 0182)
  • Christchurch, New Zealand, 8011
    • Christchurch Heart Institute ( Site 0280)
  • Christchurch, New Zealand, 8013
    • Southern Clinical Trials Ltd ( Site 0180)
  • Rotorua, New Zealand, 3010
    • Lakeland Clinical Trials ( Site 0181)
  • Tauranga, New Zealand, 3143
    • Bay of Plenty Clinical School ( Site 0186)
  • Wellington, New Zealand, 6021
    • P3 Research Ltd - Wellington ( Site 0184)
• Poland
  • Bydgoszcz, Poland, 85-030
    • WSOZ im.T.Browicza w Bydgoszczy ( Site 0317)
  • Bydgoszcz, Poland, 85-796
    • Centrum Medyczne Pratia Bydgoszcz ( Site 0139)
  • Gdansk, Poland, 80-382
    • Synexus Polska Sp. z o.o. ( Site 0238)
  • Krakow, Poland, 30-033
    • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233)
  • Myslowice, Poland, 41-400
    • ID Clinic ( Site 0235)
  • Skierniewice, Poland, 96-100
    • Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319)
  • Sopot, Poland, 81-717
    • Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314)
  • Wroclaw, Poland, 50-136
    • Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236)
  • Wroclaw, Poland, 50-381
    • Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234)
• Russian Federation
  • Kazan, Russian Federation, 420140
    • Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249)
  • Saratov, Russian Federation, 410054
    • Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144)
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical University ( Site 0246)
• United States
  • Arizona
    • Chinle, Arizona, United States, 86503
      • Chinle Comprehensive Health Care Facility ( Site 0001)
    • Fort Defiance, Arizona, United States, 86504
      • Fort Defiance Center for American Indian Health ( Site 0002)
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates, PA ( Site 0043)
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical Clinic, LLC ( Site 0031)
    • Whiteriver, Arizona, United States, 85941
      • Whiteriver Center for American Indian Health ( Site 0005)
  • California
    • Rialto, California, United States, 92377
      • Inland Empire Clinical Trials, LLC ( Site 0052)
  • Florida
    • Cutler Bay, Florida, United States, 33189
      • Top Medical Research, Inc ( Site 0033)
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc ( Site 0054)
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research ( Site 0008)
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute, P.A. ( Site 0026)
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine at Grady Hospital ( Site 0027)
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Health ( Site 0042)
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare & Research, LLC. ( Site 0012)
    • Evergreen Park, Illinois, United States, 60805
      • Pharmakon Inc ( Site 0049)
  • Indiana
    • Richmond, Indiana, United States, 47374
      • Reid Physician Associates ( Site 0055)
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research PC ( Site 0050)
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium ( Site 0053)
  • New Jersey
    • Bridgeton, New Jersey, United States, 08302
      • Internal Medicine Associates [Bridgeton, NJ] ( Site 0015)
  • New Mexico
    • Gallup, New Mexico, United States, 87301
      • Gallup Center for American Indian Health ( Site 0003)
    • Shiprock, New Mexico, United States, 87420
      • Shiprock Center for American Indian Health ( Site 0004)
  • New York
    • Corning, New York, United States, 14830
      • Corning Center For Clinical Research ( Site 0036)
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research ( Site 0022)
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC ( Site 0016)
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
      • Lehigh Valley Health Network ( Site 0040)
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania ( Site 0030)
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Mountain View Clinical Research ( Site 0007)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group ( Site 0025)
  • Texas
    • Fort Worth, Texas, United States, 76104
      • AIM Trials ( Site 0060)
    • Galveston, Texas, United States, 77555-1115
      • University of Texas Medical Branch at Galveston ( Site 0034)
    • Houston, Texas, United States, 77094
      • Private Practice Leadership, LLC ( Site 0051)
    • Houston, Texas, United States, 77801
      • Texas Center For Drug Development ( Site 0041)
    • McKinney, Texas, United States, 75071
      • Texas Institute Of Cardiology ( Site 0048)
    • Plano, Texas, United States, 75024
      • Village Health Partners ( Site 0006)
  • Utah
    • South Jordan, Utah, United States, 84095
      • Copperview Medical Center ( Site 0038)
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Timber Lane Allergy & Asthma Research, LLC ( Site 0044)
  • Washington
    • Spokane Valley, Washington, United States, 99216
      • Pulmonary & Sleep Research ( Site 0046)
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Health System ( Site 0021)
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic ( Site 0013)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) <10%
  2. Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)
  3. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3
  4. Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy
  5. 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.
  6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: PPV23
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: 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: PPV23; 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: PCV13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™	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.	Up to 5 days after Vaccination 1
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™	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.	Up to 14 days after Vaccination 1
Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™	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.	Up to Month 6 (before Vaccination 2)
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™	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.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23	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.	Up to 5 days after Vaccination 2 (Month 6)
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23	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.	Up to 14 days after Vaccination 2 (Month 6)
Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23	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.	From Month 6 (before Vaccination 2) to Month 7
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 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.	Day 30
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to 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.	Day 1 (Baseline) and Day 30
GMFR in Serotype-specific IgG Day 1 to 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.	Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to 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.	Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to 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.	Day 1 (Baseline) and Day 30
Geometric Mean Titer of Serotype-specific OPA at 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.	Month 7
Geometric Mean Concentration of Serotype-specific IgG at 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.	Month 7
GMFR in Serotype-specific OPA Day 1 to 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.	Day 1 (Baseline) and Month 7
GMFR in Serotype-specific IgG Day 1 to 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.	Day 1 (Baseline) and Month 7
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to 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.	Day 1 (Baseline) and Month 7
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to 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.	Day 1 (Baseline) and Month 7
GMFR in Serotype-specific OPA Month 6 to 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.	Month 6 (Baseline before Vaccination 2) and Month 7
GMFR in Serotype-specific IgG Month 6 to 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.	Month 6 (Baseline before Vaccination 2) and Month 7
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to 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.	Month 6 (Baseline before Vaccination 2) and Month 7
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to 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.	Month 6 (Baseline before Vaccination 2) and Month 7

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Hammitt LL, Quinn D, Janczewska E, Pasquel FJ, Tytus R, Rajender Reddy K, Abarca K, Khaertynova IM, Dagan R, McCauley J, Cheon K, Pedley A, Sterling T, Tamms G, Musey L, Buchwald UK. Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY). Open Forum Infect Dis. 2021 Dec 18;9(3):ofab605. doi: 10.1093/ofid/ofab605. eCollection 2022 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: V114-017 (Other Identifier: Merck Protocol Number); 2017-004915-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No