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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03547167




Registration number
NCT03547167
Ethics application status
Date submitted
24/05/2018
Date registered
6/06/2018
Date last updated
17/06/2019

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2017-004915-38
Secondary ID [2] 0 0
V114-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - V114
Other interventions - Prevnar 13™
Other interventions - PNEUMOVAX™23

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)

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)


Other interventions: 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

Other interventions: 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 interventions: 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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with a Solicited Injection-site Adverse Event - 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. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.
Timepoint [1] 0 0
Up to Day 5 after Vaccination 1
Primary outcome [2] 0 0
Percentage of Participants with a Solicited Systemic Adverse Event - An 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. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Timepoint [2] 0 0
Up to Day 14 after Vaccination 1
Primary outcome [3] 0 0
Percentage of Participants with a Vaccine-related Serious Adverse Event - 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 will be determined by the investigator.
Timepoint [3] 0 0
Up to Month 6 (before Vaccination 2)
Primary outcome [4] 0 0
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
Timepoint [4] 0 0
Day 30
Secondary outcome [1] 0 0
Percentage of Participants with a Solicited Injection-site Adverse Event - An 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. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.
Timepoint [1] 0 0
Up to Day 5 after Vaccination 2 (Month 6)
Secondary outcome [2] 0 0
Percentage of Participants with a Solicited Systemic Adverse Event - An 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. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Timepoint [2] 0 0
Up to Day 14 after Vaccination 2 (Month 6)
Secondary outcome [3] 0 0
Percentage of Participants with a Vaccine-related Serious Adverse Event - An 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 will be determined by the investigator.
Timepoint [3] 0 0
From Month 6 (before Vaccination 2) to Month 7
Secondary outcome [4] 0 0
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
Timepoint [4] 0 0
Day 30
Secondary outcome [5] 0 0
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Day 30 / GMT at Day 1.
Timepoint [5] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [6] 0 0
GMFR in Serotype-specific IgG - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Day 30 / GMC at Day 1.
Timepoint [6] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [7] 0 0
Percentage of Participants with GMFR =4 in Serotype-specific OPA - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
Timepoint [7] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [8] 0 0
Percentage of Participants with GMFR =4 in Serotype-specific IgG - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
Timepoint [8] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [9] 0 0
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
Timepoint [9] 0 0
Month 7
Secondary outcome [10] 0 0
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
Timepoint [10] 0 0
Month 7
Secondary outcome [11] 0 0
GMFR in Serotype-specific OPA - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Month 7 / GMT at Day 1.
Timepoint [11] 0 0
Day 1 (Baseline) and Month 7
Secondary outcome [12] 0 0
GMFR in Serotype-specific IgG - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Month 7 / GMC at Day 1.
Timepoint [12] 0 0
Day 1 (Baseline) and Month 7
Secondary outcome [13] 0 0
Percentage of Participants with GMFR =4 in Serotype-specific OPA - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
Timepoint [13] 0 0
Day 1 (Baseline) and Month 7
Secondary outcome [14] 0 0
Percentage of Participants with GMFR =4 in Serotype-specific IgG - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
Timepoint [14] 0 0
Day 1 (Baseline) and Month 7
Secondary outcome [15] 0 0
GMFR in Serotype-specific OPA - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT at Month 7 / GMT at Month 6.
Timepoint [15] 0 0
Month 6 (Baseline before Vaccination 2) and Month 7
Secondary outcome [16] 0 0
GMFR in Serotype-specific IgG - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC at Month 7 / GMC at Month 6.
Timepoint [16] 0 0
Month 6 (Baseline before Vaccination 2) and Month 7
Secondary outcome [17] 0 0
Percentage of Participants with GMFR =4 in Serotype-specific OPA - Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.
Timepoint [17] 0 0
Month 6 (Baseline before Vaccination 2) and Month 7
Secondary outcome [18] 0 0
Percentage of Participants with GMFR =4 in Serotype-specific IgG - Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.
Timepoint [18] 0 0
Month 6 (Baseline before Vaccination 2) and Month 7

Eligibility
Key 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 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.
Minimum age
18 Years
Maximum age
49 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
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 - 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 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174) - Blacktown
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice ( Site 0170) - Sydney
Recruitment hospital [3] 0 0
Core Research Group Pty limited ( Site 0175) - Brisbane
Recruitment hospital [4] 0 0
Emeritus Research Pty Ltd ( Site 0173) - Camberwell
Recruitment hospital [5] 0 0
Paratus Clinical Kanwal ( Site 0172) - Kanwal
Recruitment hospital [6] 0 0
Nepean Hospital ( Site 0176) - Kingswood
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4064 - Brisbane
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
2259 - Kanwal
Recruitment postcode(s) [6] 0 0
2747 - Kingswood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
New Brunswick
Country [24] 0 0
Canada
State/province [24] 0 0
Nova Scotia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Chile
State/province [27] 0 0
RM
Country [28] 0 0
Chile
State/province [28] 0 0
Santiago
Country [29] 0 0
Chile
State/province [29] 0 0
Temuco
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
New Zealand
State/province [31] 0 0
Christchurch
Country [32] 0 0
New Zealand
State/province [32] 0 0
Rotorua
Country [33] 0 0
New Zealand
State/province [33] 0 0
Tauranga
Country [34] 0 0
New Zealand
State/province [34] 0 0
Wellington
Country [35] 0 0
Poland
State/province [35] 0 0
Bydgoszcz
Country [36] 0 0
Poland
State/province [36] 0 0
Gdansk
Country [37] 0 0
Poland
State/province [37] 0 0
Krakow
Country [38] 0 0
Poland
State/province [38] 0 0
Myslowice
Country [39] 0 0
Poland
State/province [39] 0 0
Skierniewice
Country [40] 0 0
Poland
State/province [40] 0 0
Sopot
Country [41] 0 0
Poland
State/province [41] 0 0
Wroclaw
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Kazan
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Saratov
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Smolensk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
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 3) living in a community/environment with increased risk of disease
transmission.
Trial website
https://clinicaltrials.gov/show/NCT03547167
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications