Back to resultsA 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)
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V114
Prevnar 13™
PNEUMOVAX™23
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections
Eligibility Criteria
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.
Sites / Locations
- Chinle Comprehensive Health Care Facility ( Site 0001)
- Fort Defiance Center for American Indian Health ( Site 0002)
- Pulmonary Associates, PA ( Site 0043)
- Central Phoenix Medical Clinic, LLC ( Site 0031)
- Whiteriver Center for American Indian Health ( Site 0005)
- Inland Empire Clinical Trials, LLC ( Site 0052)
- Top Medical Research, Inc ( Site 0033)
- Indago Research & Health Center, Inc ( Site 0054)
- Renstar Medical Research ( Site 0008)
- Triple O Research Institute, P.A. ( Site 0026)
- Emory University School of Medicine at Grady Hospital ( Site 0027)
- Kootenai Health ( Site 0042)
- Evanston Premier Healthcare & Research, LLC. ( Site 0012)
- Pharmakon Inc ( Site 0049)
- Reid Physician Associates ( Site 0055)
- The Center for Pharmaceutical Research PC ( Site 0050)
- Clinical Research Consortium ( Site 0053)
- Internal Medicine Associates [Bridgeton, NJ] ( Site 0015)
- Gallup Center for American Indian Health ( Site 0003)
- Shiprock Center for American Indian Health ( Site 0004)
- Corning Center For Clinical Research ( Site 0036)
- Mid Hudson Medical Research ( Site 0022)
- Wake Research Associates, LLC ( Site 0016)
- Lehigh Valley Health Network ( Site 0040)
- University of Pennsylvania ( Site 0030)
- Mountain View Clinical Research ( Site 0007)
- Holston Medical Group ( Site 0025)
- AIM Trials ( Site 0060)
- University of Texas Medical Branch at Galveston ( Site 0034)
- Private Practice Leadership, LLC ( Site 0051)
- Texas Center For Drug Development ( Site 0041)
- Texas Institute Of Cardiology ( Site 0048)
- Village Health Partners ( Site 0006)
- Copperview Medical Center ( Site 0038)
- Timber Lane Allergy & Asthma Research, LLC ( Site 0044)
- Pulmonary & Sleep Research ( Site 0046)
- Gundersen Health System ( Site 0021)
- Marshfield Clinic ( Site 0013)
- Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174)
- Holdsworth House Medical Practice ( Site 0170)
- Core Research Group Pty limited ( Site 0175)
- Emeritus Research Pty Ltd ( Site 0173)
- Paratus Clinical Kanwal ( Site 0172)
- Nepean Hospital ( Site 0176)
- The Liver and Intestinal Research Centre (LAIR) ( Site 0302)
- GA Research Associates, Ltd/Ltee ( Site 0303)
- Colchester Research Group ( Site 0094)
- Hamilton Medical Research Group ( Site 0092)
- SKDS Research Inc. ( Site 0099)
- Omnispec Recherche Clinique Inc ( Site 0093)
- Dynamik Research ( Site 0095)
- Q & T Research Sherbrooke Inc. ( Site 0097)
- Diex Recherche Quebec Inc ( Site 0091)
- Clinica Arauco Salud ( Site 0100)
- Centro de Investigacion Clinica UC CICUC ( Site 0104)
- CECIM ( Site 0101)
- CESFAM Esmeralda ( Site 0102)
- Hospital Dr. Hernan Henriquez Aravena ( Site 0105)
- Southern Clinical Trials - Waitemata ( Site 0183)
- Auckland Clinical Studies Limited ( Site 0189)
- Optimal Clinical Trials ( Site 0182)
- Christchurch Heart Institute ( Site 0280)
- Southern Clinical Trials Ltd ( Site 0180)
- Lakeland Clinical Trials ( Site 0181)
- Bay of Plenty Clinical School ( Site 0186)
- P3 Research Ltd - Wellington ( Site 0184)
- WSOZ im.T.Browicza w Bydgoszczy ( Site 0317)
- Centrum Medyczne Pratia Bydgoszcz ( Site 0139)
- Synexus Polska Sp. z o.o. ( Site 0238)
- Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233)
- ID Clinic ( Site 0235)
- Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319)
- Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314)
- Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236)
- Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234)
- Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249)
- Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144)
- Smolensk State Medical University ( Site 0246)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
V114
Prevnar 13™
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03547167
First Posted
May 24, 2018
Last Updated
December 21, 2020
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03547167
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1515 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V114
Arm Type
Experimental
Arm Description
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)
Arm Title
Prevnar 13™
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
V114
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Prevnar 13™
Other Intervention Name(s)
PCV13
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
PNEUMOVAX™23
Other Intervention Name(s)
PPV23
Intervention Description
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
Primary Outcome Measure Information:
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
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
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)
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
Secondary Outcome Measure Information:
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Chinle Comprehensive Health Care Facility ( Site 0001)
City
Chinle
State/Province
Arizona
ZIP/Postal Code
86503
Country
United States
Facility Name
Fort Defiance Center for American Indian Health ( Site 0002)
City
Fort Defiance
State/Province
Arizona
ZIP/Postal Code
86504
Country
United States
Facility Name
Pulmonary Associates, PA ( Site 0043)
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Central Phoenix Medical Clinic, LLC ( Site 0031)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Whiteriver Center for American Indian Health ( Site 0005)
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Name
Inland Empire Clinical Trials, LLC ( Site 0052)
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Top Medical Research, Inc ( Site 0033)
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Indago Research & Health Center, Inc ( Site 0054)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Renstar Medical Research ( Site 0008)
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Triple O Research Institute, P.A. ( Site 0026)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University School of Medicine at Grady Hospital ( Site 0027)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Kootenai Health ( Site 0042)
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Evanston Premier Healthcare & Research, LLC. ( Site 0012)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Pharmakon Inc ( Site 0049)
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Reid Physician Associates ( Site 0055)
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
The Center for Pharmaceutical Research PC ( Site 0050)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Clinical Research Consortium ( Site 0053)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Internal Medicine Associates [Bridgeton, NJ] ( Site 0015)
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
Country
United States
Facility Name
Gallup Center for American Indian Health ( Site 0003)
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
Facility Name
Shiprock Center for American Indian Health ( Site 0004)
City
Shiprock
State/Province
New Mexico
ZIP/Postal Code
87420
Country
United States
Facility Name
Corning Center For Clinical Research ( Site 0036)
City
Corning
State/Province
New York
ZIP/Postal Code
14830
Country
United States
Facility Name
Mid Hudson Medical Research ( Site 0022)
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Wake Research Associates, LLC ( Site 0016)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Lehigh Valley Health Network ( Site 0040)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
University of Pennsylvania ( Site 0030)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mountain View Clinical Research ( Site 0007)
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Holston Medical Group ( Site 0025)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
AIM Trials ( Site 0060)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Branch at Galveston ( Site 0034)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1115
Country
United States
Facility Name
Private Practice Leadership, LLC ( Site 0051)
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
Texas Center For Drug Development ( Site 0041)
City
Houston
State/Province
Texas
ZIP/Postal Code
77801
Country
United States
Facility Name
Texas Institute Of Cardiology ( Site 0048)
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Village Health Partners ( Site 0006)
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Copperview Medical Center ( Site 0038)
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Timber Lane Allergy & Asthma Research, LLC ( Site 0044)
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Pulmonary & Sleep Research ( Site 0046)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Gundersen Health System ( Site 0021)
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Marshfield Clinic ( Site 0013)
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174)
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Holdsworth House Medical Practice ( Site 0170)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Core Research Group Pty limited ( Site 0175)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Emeritus Research Pty Ltd ( Site 0173)
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Paratus Clinical Kanwal ( Site 0172)
City
Kanwal
ZIP/Postal Code
2259
Country
Australia
Facility Name
Nepean Hospital ( Site 0176)
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Facility Name
The Liver and Intestinal Research Centre (LAIR) ( Site 0302)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
GA Research Associates, Ltd/Ltee ( Site 0303)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Colchester Research Group ( Site 0094)
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Hamilton Medical Research Group ( Site 0092)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
SKDS Research Inc. ( Site 0099)
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Omnispec Recherche Clinique Inc ( Site 0093)
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Dynamik Research ( Site 0095)
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Q & T Research Sherbrooke Inc. ( Site 0097)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
Diex Recherche Quebec Inc ( Site 0091)
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Clinica Arauco Salud ( Site 0100)
City
Santiago
State/Province
RM
ZIP/Postal Code
7560994
Country
Chile
Facility Name
Centro de Investigacion Clinica UC CICUC ( Site 0104)
City
Santiago
ZIP/Postal Code
8330034
Country
Chile
Facility Name
CECIM ( Site 0101)
City
Santiago
ZIP/Postal Code
8330336
Country
Chile
Facility Name
CESFAM Esmeralda ( Site 0102)
City
Santiago
ZIP/Postal Code
9351603
Country
Chile
Facility Name
Hospital Dr. Hernan Henriquez Aravena ( Site 0105)
City
Temuco
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Southern Clinical Trials - Waitemata ( Site 0183)
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Auckland Clinical Studies Limited ( Site 0189)
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Optimal Clinical Trials ( Site 0182)
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Christchurch Heart Institute ( Site 0280)
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Southern Clinical Trials Ltd ( Site 0180)
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Lakeland Clinical Trials ( Site 0181)
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Bay of Plenty Clinical School ( Site 0186)
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
P3 Research Ltd - Wellington ( Site 0184)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
WSOZ im.T.Browicza w Bydgoszczy ( Site 0317)
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Centrum Medyczne Pratia Bydgoszcz ( Site 0139)
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. ( Site 0238)
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233)
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
ID Clinic ( Site 0235)
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319)
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314)
City
Sopot
ZIP/Postal Code
81-717
Country
Poland
Facility Name
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236)
City
Wroclaw
ZIP/Postal Code
50-136
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234)
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249)
City
Kazan
ZIP/Postal Code
420140
Country
Russian Federation
Facility Name
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144)
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Smolensk State Medical University ( Site 0246)
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35146039
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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