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Vaccine

V116 for Pneumococcal Disease (STRIDE-3 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 194 days postvaccination
Awards & highlights

STRIDE-3 Trial Summary

This trial is testing a new pneumococcal vaccine (V116) to see if it is safe, effective, and tolerable. The study will compare V116 to another pneumococcal vaccine (PCV20) in people who have not received a pneumococcal vaccine before. It is expected that V116 will be at least as good as PCV20 for the common serotypes and better than PCV20 for the unique serotypes.

Eligible Conditions
  • Pneumococcal Disease

STRIDE-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 194 days postvaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 194 days postvaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with solicited injection-site adverse events (AEs)
Percentage of participants with solicited systemic AEs
Percentage of participants with vaccine-related serious AE (SAE)
+2 more
Secondary outcome measures
GMFR from baseline in serotype specific IgG GMCs in Cohort 1
Geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs in Cohort 1
Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG GMCs in Cohort 1
+4 more

Side effects data

From 2021 Phase 1 & 2 trial • 600 Patients • NCT04168190
38%
Injection site pain
16%
Headache
13%
Fatigue
10%
Myalgia
8%
Injection site swelling
7%
Injection site erythema
5%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: PPSV23
Phase 2: V116
Phase 1: V116 0.5 mL
Phase 1: V116 1.0 mL
Phase 1: PPSV23

STRIDE-3 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2 V116Experimental Treatment1 Intervention
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
Group II: Cohort 1 V116Experimental Treatment1 Intervention
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
Group III: Cohort 1 PCV20Active Control1 Intervention
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
Group IV: Cohort 2 PCV20Active Control1 Intervention
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V116
2022
Completed Phase 3
~8610

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,052,393 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,061,200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are actively involved at this time?

"2600 patients who meet the clinical study's inclusion criteria are required to carry out the research project. The sponsor, Merck Sharp & Dohme LLC, will be managing the trial from various locations; for example, Alliance for Multispecialty Research, LLC ( Site 0026) in Kansas City, Missouri and Aventiv Research Inc ( Site 0044) in Columbus, Ohio."

Answered by AI

Has V116 been greenlit by the FDA?

"V116 has been studied in Phase 3 trials, meaning that there is both evidence of its efficacy and multiple rounds of data supporting its safety. Our team at Power rates the safety of V116 as a 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Elixir Research Group - W Houston ( Site 0068)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
2022. "Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425732.
~969 spots leftby Apr 2025
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