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Vaccine
V116 Vaccine for Pneumococcal Disease (STRIDE-8 Trial)
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 6
Awards & highlights
STRIDE-8 Trial Summary
This trial studies the safety & tolerability of a vaccine to protect adults against pneumococcal diseases. It also evaluates how well the vaccine works.
Who is the study for?
Adults at high risk for pneumococcal disease, stable on current treatments with conditions like diabetes (with controlled HbA1c), chronic liver disease, COPD, asthma, heart or kidney disease. Must not be pregnant or planning to get pregnant and agree to use contraception if of childbearing potential. Excludes those with recent severe infections, hypersensitivity to vaccine components, bleeding disorders preventing shots, active cancer treatment within 3 years, planned major surgery or organ transplant during the study.Check my eligibility
What is being tested?
The trial is testing a new vaccine called V116 against pneumococcal diseases compared to an existing vaccine regimen including PCV15 and PPSV23. It aims to assess safety and immune response by measuring how well the body can fight off the bacteria after vaccination.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site such as pain and swelling, feverish symptoms similar to mild flu-like illness. There may also be allergic reactions in rare cases due to sensitivity towards any component of the vaccines.
STRIDE-8 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a condition like diabetes, liver disease, COPD, asthma, heart or kidney disease.
STRIDE-8 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination
Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
+1 moreSecondary outcome measures
Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination
Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
+2 moreSTRIDE-8 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: V116Experimental Treatment2 Interventions
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
Group II: PCV15 + PPSV23Active Control2 Interventions
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V116
2022
Completed Phase 3
~8610
Placebo for PCV15 + PPSV23
2023
Completed Phase 3
~520
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,053 Total Patients Enrolled
Clinical DirectorStudy DirectorMerck Sharp & Dohme LLC
17 Previous Clinical Trials
3,977 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or stroke in the last 3 months.You are allergic to any ingredient in V116, PCV15, or PPSV23 vaccines, including diphtheria toxoid.I have a blood clotting disorder that prevents me from getting shots in my muscles.I haven't had a fever or taken antibiotics in the last 3 days.I have a history of chronic kidney issues or autoimmune kidney disease.I have a condition like diabetes, liver disease, COPD, asthma, heart or kidney disease.I have not received a blood transfusion or blood products in the last 6 months, nor will I receive them within 30 days after getting a study vaccine.My current treatment for my condition has been stable for over 3 months with no major changes expected.I have severe lung blood pressure or Eisenmenger syndrome.I am not able to have children, or I use birth control or practice long-term abstinence.I've been on steroids (20 mg or more daily) for 2 weeks and haven't stopped them 14 days before the study vaccine.I have had or will have a pneumococcal vaccine outside this study's protocol.I am scheduled for a major organ transplant or surgery during this study.I haven't had a live virus vaccine in the last 30 days and won't have one for 30 days after getting the study vaccine.I use oxygen at home regularly.I have had active hepatitis in the past.I am currently on medication that affects my immune system.I had a serious lung infection confirmed by a lab test in the last 3 years.I have a cancer that is getting worse or needed treatment in the last 3 years.I haven't had non-live vaccines 2 weeks before or plan to within 30 days after the study vaccine.You have a weakened immune system due to conditions like HIV, autoimmune disease, or a missing spleen.The doctors believe you may have less than one year to live.I have had diabetic ketoacidosis or two severe low blood sugar episodes recently.
Research Study Groups:
This trial has the following groups:- Group 1: V116
- Group 2: PCV15 + PPSV23
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To which demographic is this research study open?
"In order to be considered, potential participants must have pneumococcal disease and fall within the age bracket of 18-64. A total of 500 individuals are needed for this clinical experiment."
Answered by AI
Does this research project restrict participation to individuals over 35 years old?
"Patients aged 18 to 64 are the only ones eligible for this clinical trial. For those younger or older, there are 11 and 12 respective studies available."
Answered by AI
Has V116 been validated by the Food and Drug Administration?
"The safety of V116 has been rated a 3, as there is evidence confirming its efficacy and numerous rounds of data which support its security."
Answered by AI
Is this research project currently accepting new participants?
"Affirmative. Clinicaltrials.gov has evidence that this medical experiment began recruitment on February 13th 2023 and is actively recruiting patients at the present time. In total, 500 individuals are needed across 8 distinct locations."
Answered by AI
Are there multiple facilities administering this research endeavor in the region?
"Currently, this clinical trial is recruiting subjects from 8 separate sites. These locations include West Palm Beach, Ridgeland and Durham amongst others. To reduce the amount of travel required to participate it is suggested that you select a site in proximity to your own location."
Answered by AI
What is the total sample size for this research project?
"In order to conduct this medical trial, 500 participants must be secured that meet the established inclusion criteria. Individuals can sign up through Triple O Research Institute in West Palm Beach and SKY Integrative Medical Center/SKYCRNG in Ridgeland."
Answered by AI
What is the primary objective of this clinical experiment?
"This clinical trial will primarily focus on assessing the occurrence of vaccine-related serious adverse events (SAEs) over a period of 5 days. Secondary objectives include measuring serotype-specific GMFRs and percentage of participants that experience a ≥4-fold rise in immunoglobulin G (IgG) or OPA responses post vaccination with V116 and PCV15 + PPSV2 respectively."
Answered by AI
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