Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05696080




Registration number
NCT05696080
Ethics application status
Date submitted
13/01/2023
Date registered
25/01/2023
Date last updated
27/11/2024

Titles & IDs
Public title
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
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
Secondary ID [1] 0 0
V116-008
Secondary ID [2] 0 0
V116-008
Universal Trial Number (UTN)
Trial acronym
STRIDE-8
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - V116
Treatment: Drugs - Placebo for PCV15 + PPSV23
Treatment: Other - PCV15
Treatment: Other - 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.


Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination
Timepoint [1] 0 0
Up to Day 5
Primary outcome [2] 0 0
Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
Timepoint [2] 0 0
Up to Day 5
Primary outcome [3] 0 0
Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
Timepoint [3] 0 0
Up to Month 6
Primary outcome [4] 0 0
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination
Timepoint [4] 0 0
Up to Week 12
Secondary outcome [1] 0 0
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination
Timepoint [1] 0 0
Up to Week 12
Secondary outcome [2] 0 0
Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
Timepoint [2] 0 0
Baseline and up to Week 12
Secondary outcome [3] 0 0
Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses
Timepoint [3] 0 0
Baseline and up to Week 12
Secondary outcome [4] 0 0
Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
Timepoint [4] 0 0
Baseline and up to Week 12
Secondary outcome [5] 0 0
Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2
Timepoint [5] 0 0
Baseline and up to Week 12

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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/02/2024
Sample size
Target
Accrual to date
Final
518
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice ( Site 0402) - Darlinghurst
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital ( Site 0400) - Brisbane
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Mississippi
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Canada
State/province [8] 0 0
New Brunswick
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Chile
State/province [11] 0 0
Araucania
Country [12] 0 0
Chile
State/province [12] 0 0
Maule
Country [13] 0 0
Chile
State/province [13] 0 0
Region M. De Santiago
Country [14] 0 0
Japan
State/province [14] 0 0
Fukuoka
Country [15] 0 0
Japan
State/province [15] 0 0
Yamaguchi
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Kyonggi-do
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
New Zealand
State/province [18] 0 0
Bay Of Plenty
Country [19] 0 0
New Zealand
State/province [19] 0 0
Canterbury
Country [20] 0 0
New Zealand
State/province [20] 0 0
Wellington
Country [21] 0 0
Poland
State/province [21] 0 0
Kujawsko-pomorskie
Country [22] 0 0
Poland
State/province [22] 0 0
Lodzkie
Country [23] 0 0
Poland
State/province [23] 0 0
Podkarpackie
Country [24] 0 0
Poland
State/province [24] 0 0
Slaskie

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05696080
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Director
Address 0 0
Merck Sharp & Dohme LLC
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05696080