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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05696080
Registration number
NCT05696080
Ethics application status
Date submitted
13/01/2023
Date registered
25/01/2023
Date last updated
28/02/2024
Titles & IDs
Public title
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
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Scientific title
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease
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Secondary ID [1]
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V116-008
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Secondary ID [2]
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V116-008
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Universal Trial Number (UTN)
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Trial acronym
STRIDE-8
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infection
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - V116
Treatment: Drugs - Placebo for PCV15 + PPSV23
Other interventions - PCV15
Other interventions - PPSV23
Experimental: V116 - Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo for PCV15 + PPSV23 on Week 8
Active Comparator: PCV15 + PPSV23 - Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
Other interventions: V116
Pneumococcal 21-valent conjugate vaccine with 4 µg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Treatment: Drugs: Placebo for PCV15 + PPSV23
Saline in each 0.5 mL sterile solution
Other interventions: PCV15
Pneumococcal 15-valent conjugate vaccine with 2 µg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 µg of PnPs antigen 6B in each 0.5 mL sterile suspension
Other interventions: PPSV23
Pneumococcal 23-valent polyvalent vaccine with 25 µg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination
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Assessment method [1]
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Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 post-vaccination
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Timepoint [1]
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Up to Day 5
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Primary outcome [2]
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Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
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Assessment method [2]
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Percentage of participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
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Timepoint [2]
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Up to Day 5
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Primary outcome [3]
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Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
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Assessment method [3]
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Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in the study
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Timepoint [3]
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Up to Month 6
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Primary outcome [4]
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Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination
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Assessment method [4]
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Serotype-specific OPA GMTs post-vaccination with V116 (30 days post-vaccination [Day 30]) or PCV15 + PPSV23 (30 days post-vaccination with the final dose in the regimen [Week 12])
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Timepoint [4]
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Up to Week 12
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Secondary outcome [1]
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Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination
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Assessment method [1]
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Serotype-specific IgG GMCs post-vaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12)
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Timepoint [1]
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Up to Week 12
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Secondary outcome [2]
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Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
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Assessment method [2]
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Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post=vaccination with PCV15 + PPSV2 (Week 12) for OPA responses
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Timepoint [2]
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Baseline and up to Week 12
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Secondary outcome [3]
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Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses
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Assessment method [3]
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Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV23 (Week 12) for IgG responses
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Timepoint [3]
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Baseline and up to Week 12
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Secondary outcome [4]
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Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
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Assessment method [4]
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Serotype-specific percentage of participants with a =4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for OPA responses
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Timepoint [4]
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Baseline and up to Week 12
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Secondary outcome [5]
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Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2
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Assessment method [5]
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Serotype-specific proportion of participants with a =4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for IgG responses
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Timepoint [5]
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Baseline and up to Week 12
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Eligibility
Key inclusion criteria
- Has documented result(s) of =1 of the following risk conditions for pneumococcal
disease: diabetes mellitus, receiving treatment with =1 approved antidiabetic
medication, with all Hemoglobin A1c (HbA1c) measurements =9% within 6 months before
first study vaccination; compensated chronic liver disease; diagnosis of chronic
obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild
or moderate persistent asthma managed per local guidelines; confirmed diagnosis of
chronic heart disease managed per local guidelines; confirmed diagnosis of chronic
kidney disease (>3 months duration).
- Is receiving stable medical management for the listed risk conditions for =3 months
with no anticipated major change in treatment expected for the duration of the study
and with =1 hospitalization directly related to the risk condition.
- Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an
acceptable contraceptive method or is abstinent from penile-vaginal intercourse as
their preferred and usual lifestyle (abstinent on a long-term and persistent basis);
their medical history, menstrual history, and recent sexual activity has been reviewed
by the investigator.
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Has a history of active hepatitis.
- Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic
hypoglycemia within 3 months before first study vaccination (Day 1).
- Has a history of myocardial infarction, acute coronary syndrome, transient ischemic
attack, or ischemic or hemorrhagic stroke within 3 months before first study
vaccination (Day 1).
- Has a history of severe pulmonary hypertension with World Health Organization (WHO)
functional class =3 or history of Eisenmenger syndrome
- Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a
reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney
Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration
rate (GFR) and Albuminuria
- Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive
cerebrospinal fluid culture, or positive culture at another sterile site) or known
history of other culture-positive pneumococcal disease within 3 years before first
study vaccination (Day 1).
- Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including
diphtheria toxoid.
- Has a known or suspected impairment of immunological function including, but not
limited to, congenital or acquired immunodeficiency, documented human immunodeficiency
virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease.
- Has a coagulation disorder contraindicating intramuscular (IM) vaccination.
- Had a recent febrile illness or received antibiotic therapy for any acute illness
occurring within 72 hours before receipt of any study vaccine.
- Has a known malignancy that is progressing or has required active treatment <3 years
before randomization.
- Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other
planned major surgical procedure during the duration of this study.
- Has expected survival for <1 year.
- Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal
vaccine during the study outside the protocol.
- Has received systemic corticosteroids (prednisone equivalent of =20 mg/day) for =14
consecutive days and has not completed intervention =14 days before receipt of study
vaccine at Visit 2 (Day 1).
- Is currently receiving systemic immunosuppressive therapy, including chemotherapeutic
agents or other immunotherapies/immunomodulators used to treat cancer or other
conditions, and interventions associated with organ or bone marrow transplantation, or
autoimmune disease.
- Has received any non-live vaccine =14 days before receipt of any study vaccine or is
scheduled to receive any non-live vaccine =30 days after receipt of any study vaccine.
- Has received any live virus vaccine (including severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) live virus vaccines) =30 days before receipt of any study
vaccine or is scheduled to receive any live virus vaccine =30 days after receipt of
any study vaccine
- Has received a blood transfusion or blood products, including immunoglobulin =6 months
before receipt of any study vaccine or is scheduled to receive a blood transfusion or
blood product =30 days after receipt of any study vaccine.
- Is receiving chronic home oxygen therapy.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/02/2024
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Sample size
Target
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Accrual to date
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Final
518
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Holdsworth House Medical Practice ( Site 0402) - Darlinghurst
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital ( Site 0400) - Brisbane
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Mississippi
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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United States of America
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State/province [7]
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Washington
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Country [8]
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Canada
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State/province [8]
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New Brunswick
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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Canada
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State/province [10]
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Quebec
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Country [11]
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Chile
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State/province [11]
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Araucania
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Country [12]
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Chile
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State/province [12]
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Maule
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Country [13]
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Chile
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State/province [13]
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Region M. De Santiago
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Country [14]
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Japan
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State/province [14]
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Fukuoka
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Country [15]
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Japan
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State/province [15]
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Yamaguchi
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Country [16]
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Korea, Republic of
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State/province [16]
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Kyonggi-do
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Country [17]
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Korea, Republic of
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State/province [17]
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Seoul
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Country [18]
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New Zealand
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State/province [18]
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Bay Of Plenty
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Country [19]
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New Zealand
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State/province [19]
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Canterbury
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Country [20]
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New Zealand
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State/province [20]
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Wellington
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Country [21]
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Poland
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State/province [21]
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Kujawsko-pomorskie
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Country [22]
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Poland
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State/province [22]
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Lodzkie
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Country [23]
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Poland
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State/province [23]
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Podkarpackie
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Country [24]
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Poland
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State/province [24]
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Slaskie
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are to evaluate the safety and tolerability of the
pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific
opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal
conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from
23 of the serotypes causing disease in adults) post-vaccination. within each vaccination
group separately.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05696080
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05696080
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