Pneumococcal InfectionsPhase 3NCT03547167
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 study testing V114, Prevnar 13™ and PNEUMOVAX™23 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 78 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- V114, Prevnar 13™ and PNEUMOVAX™23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,515 participants
- Where
- 78 sitesin 7 countries
- Study dates
- 16 Jul 2018to 20 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 29Show fewer
- 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.
Trial locations and contacts
78 sites in 7 countries.
78 sites in 7 countries
United States38 sites
Lehigh Valley Health Network ( Site 0040)
Allentown, Pennsylvania, 18102
Emory University School of Medicine at Grady Hospital ( Site 0027)
Atlanta, Georgia, 30303
Internal Medicine Associates [Bridgeton, NJ] ( Site 0015)
Bridgeton, New Jersey, 08302
Chinle Comprehensive Health Care Facility ( Site 0001)
Chinle, Arizona, 86503
Kootenai Health ( Site 0042)
Coeur d'Alene, Idaho, 83814
Corning Center For Clinical Research ( Site 0036)
Corning, New York, 14830
Top Medical Research, Inc ( Site 0033)
Cutler Bay, Florida, 33189
Evanston Premier Healthcare & Research, LLC. ( Site 0012)
Evanston, Illinois, 60201
Pharmakon Inc ( Site 0049)
Evergreen Park, Illinois, 60805
Fort Defiance Center for American Indian Health ( Site 0002)
Fort Defiance, Arizona, 86504
AIM Trials ( Site 0060)
Fort Worth, Texas, 76104
Gallup Center for American Indian Health ( Site 0003)
Gallup, New Mexico, 87301
University of Texas Medical Branch at Galveston ( Site 0034)
Galveston, Texas, 77555-1115
Pulmonary Associates, PA ( Site 0043)
Glendale, Arizona, 85306
Mountain View Clinical Research ( Site 0007)
Greer, South Carolina, 29651
Indago Research & Health Center, Inc ( Site 0054)
Hialeah, Florida, 33012
Private Practice Leadership, LLC ( Site 0051)
Houston, Texas, 77094
Texas Center For Drug Development ( Site 0041)
Houston, Texas, 77801
The Center for Pharmaceutical Research PC ( Site 0050)
Kansas City, Missouri, 64114
Holston Medical Group ( Site 0025)
Kingsport, Tennessee, 37660
Gundersen Health System ( Site 0021)
La Crosse, Wisconsin, 54601
Clinical Research Consortium ( Site 0053)
Las Vegas, Nevada, 89119
Marshfield Clinic ( Site 0013)
Marshfield, Wisconsin, 54449
Texas Institute Of Cardiology ( Site 0048)
McKinney, Texas, 75071
Mid Hudson Medical Research ( Site 0022)
New Windsor, New York, 12553
Renstar Medical Research ( Site 0008)
Ocala, Florida, 34471
University of Pennsylvania ( Site 0030)
Philadelphia, Pennsylvania, 19104
Central Phoenix Medical Clinic, LLC ( Site 0031)
Phoenix, Arizona, 85020
Village Health Partners ( Site 0006)
Plano, Texas, 75024
Wake Research Associates, LLC ( Site 0016)
Raleigh, North Carolina, 27612
Inland Empire Clinical Trials, LLC ( Site 0052)
Rialto, California, 92377
Reid Physician Associates ( Site 0055)
Richmond, Indiana, 47374
Shiprock Center for American Indian Health ( Site 0004)
Shiprock, New Mexico, 87420
Timber Lane Allergy & Asthma Research, LLC ( Site 0044)
South Burlington, Vermont, 05403
Copperview Medical Center ( Site 0038)
South Jordan, Utah, 84095
Pulmonary & Sleep Research ( Site 0046)
Spokane Valley, Washington, 99216
Triple O Research Institute, P.A. ( Site 0026)
West Palm Beach, Florida, 33407
Whiteriver Center for American Indian Health ( Site 0005)
Whiteriver, Arizona, 85941
Canada9 sites
Hamilton Medical Research Group ( Site 0092)
Hamilton, Ontario, L8M 1K7
Omnispec Recherche Clinique Inc ( Site 0093)
Mirabel, Quebec, J7J 2K8
GA Research Associates, Ltd/Ltee ( Site 0303)
Moncton, New Brunswick, E1G 1A7
SKDS Research Inc. ( Site 0099)
Newmarket, Ontario, L3Y 5G8
Dynamik Research ( Site 0095)
Pointe-Claire, Quebec, H9R 3J1
Diex Recherche Quebec Inc ( Site 0091)
Québec, Quebec, G1N 4V3
Q & T Research Sherbrooke Inc. ( Site 0097)
Sherbrooke, Quebec, J1J 2G2
Colchester Research Group ( Site 0094)
Truro, Nova Scotia, B2N 1L2
The Liver and Intestinal Research Centre (LAIR) ( Site 0302)
Vancouver, British Columbia, V5Z 1H2
Poland9 sites
WSOZ im.T.Browicza w Bydgoszczy ( Site 0317)
Bydgoszcz, 85-030
Centrum Medyczne Pratia Bydgoszcz ( Site 0139)
Bydgoszcz, 85-796
Synexus Polska Sp. z o.o. ( Site 0238)
Gdansk, 80-382
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233)
Krakow, 30-033
ID Clinic ( Site 0235)
Mysłowice, 41-400
Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319)
Skierniewice, 96-100
Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314)
Sopot, 81-717
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236)
Wroclaw, 50-136
Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234)
Wroclaw, 50-381
New Zealand8 sites
Southern Clinical Trials - Waitemata ( Site 0183)
Auckland, 0626
Auckland Clinical Studies Limited ( Site 0189)
Auckland, 1010
Optimal Clinical Trials ( Site 0182)
Auckland, 1010
Christchurch Heart Institute ( Site 0280)
Christchurch, 8011
Southern Clinical Trials Ltd ( Site 0180)
Christchurch, 8013
Lakeland Clinical Trials ( Site 0181)
Rotorua, 3010
Bay of Plenty Clinical School ( Site 0186)
Tauranga, 3143
P3 Research Ltd - Wellington ( Site 0184)
Wellington, 6021
Australia6 sites
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174)
Blacktown, New South Wales, 2148
Core Research Group Pty limited ( Site 0175)
Brisbane, Queensland, 4064
Emeritus Research Pty Ltd ( Site 0173)
Camberwell, Victoria, 3124
Paratus Clinical Kanwal ( Site 0172)
Kanwal, 2259
Nepean Hospital ( Site 0176)
Kingswood, 2747
Holdsworth House Medical Practice ( Site 0170)
Sydney, New South Wales, 2010
Chile5 sites
Clinica Arauco Salud ( Site 0100)
Santiago, RM, 7560994
Centro de Investigacion Clinica UC CICUC ( Site 0104)
Santiago, 8330034
CECIM ( Site 0101)
Santiago, 8330336
CESFAM Esmeralda ( Site 0102)
Santiago, 9351603
Hospital Dr. Hernan Henriquez Aravena ( Site 0105)
Temuco, 4781151
Russia3 sites
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249)
Kazan', 420140
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144)
Saratov, 410054
Smolensk State Medical University ( Site 0246)
Smolensk, 214019
About this study
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)
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.
- Conditions
- Pneumococcal Infections
- Being tested
- V114, Prevnar 13™, PNEUMOVAX™23
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V114Biological
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
Prevnar 13™Biological
Also called PCV13
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
PNEUMOVAX™23Biological
Also called PPV23
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
| Study group | Role | What they receive |
|---|---|---|
| V114 | Experimental | 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) Receives: Biological: V114; Biological: PNEUMOVAX™23 |
| Prevnar 13™ | Active comparator | 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) Receives: Biological: Prevnar 13™; Biological: PNEUMOVAX™23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6 (Baseline before Vaccination 2) and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start16 Jul 2018
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547167
- Sponsor's protocol ID
- V114-017
- Other IDs
- 2017-004915-38, V114-017, 2017
- Status last verified
- Dec 2020
- First submitted
- 24 May 2018
- Last updated
- 15 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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.
PubMed 35146039
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03547167
- Acronym / sponsor ID
- V114-017
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,515 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 15 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V114 | Experimental | Biological: V114, Biological: PNEUMOVAX™23Participants 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) |
| Prevnar 13™ | Active comparator | Biological: Prevnar 13™, Biological: PNEUMOVAX™23Participants 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) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V11415-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 | V114 |
| Prevnar 13™Also: PCV1313-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 | Biological | Prevnar 13™ |
| PNEUMOVAX™23Also: PPV2323-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 | Biological | Prevnar 13™, V114 |
Primary outcome
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Time frame: 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™
Time frame: 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™
Time frame: 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™
Time frame: 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.
18 secondary outcomes
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Time frame: Up to 5 days after Vaccination 2 (Month 6)
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Time frame: Up to 14 days after Vaccination 2 (Month 6)
Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23
Time frame: From Month 6 (before Vaccination 2) to Month 7
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
Time frame: Day 30
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific IgG Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
Geometric Mean Titer of Serotype-specific OPA at Month 7
Time frame: Month 7
Geometric Mean Concentration of Serotype-specific IgG at Month 7
Time frame: Month 7
GMFR in Serotype-specific OPA Day 1 to Month 7
Time frame: Day 1 (Baseline) and Month 7
GMFR in Serotype-specific IgG Day 1 to Month 7
Time frame: Day 1 (Baseline) and Month 7
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
Time frame: Day 1 (Baseline) and Month 7
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
Time frame: Day 1 (Baseline) and Month 7
GMFR in Serotype-specific OPA Month 6 to Month 7
Time frame: Month 6 (Baseline before Vaccination 2) and Month 7
GMFR in Serotype-specific IgG Month 6 to Month 7
Time frame: 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
Time frame: 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
Time frame: Month 6 (Baseline before Vaccination 2) and Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35146039Hammitt 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.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
78 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V114, Prevnar 13™ and PNEUMOVAX™23 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 78 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Canada, Poland, New Zealand, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ (time frame: Up to 5 days after Vaccination 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.