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Vaccine

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) (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 post-vaccination
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new vaccine called V116 in adults who have never received a pneumococcal vaccine. The goal is to see if V116 can help the body produce antibodies to protect against pneumonia and other infections caused by pneumococcal bacteria.

Eligible Conditions
  • Pneumococcal Disease

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
+3 more
Secondary study objectives
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes
+4 more

Side effects data

From 2024 Phase 3 trial • 313 Patients • NCT05393037
83%
Injection site pain
34%
Fatigue
21%
Injection site swelling
20%
Headache
15%
Myalgia
11%
Injection site erythema
6%
Diarrhoea
1%
Arthritis bacterial
1%
Pneumonia
1%
Metastases to meninges
1%
Neurosyphilis
1%
Seizure
1%
Diffuse large B-cell lymphoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
PCV15 + PPSV23
V116 + Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
4,023 Previous Clinical Trials
5,185,722 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,896 Previous Clinical Trials
8,087,353 Total Patients Enrolled
~779 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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