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Cancer Vaccine

V116 for Pneumococcal Disease (STRIDE-13 Trial)

Phase 3
Recruiting
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 completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 months
Awards & highlights

STRIDE-13 Trial Summary

This trial aims to compare the safety and effectiveness of the V116 vaccine to the PPSV23 vaccine in children and teenagers aged 2 to 17. The researchers want to see if V116

Who is the study for?
This trial is for children and teenagers aged 2 to 17 who've finished their pneumococcal conjugate vaccine series. They must have stable chronic conditions like diabetes, liver, lung, heart, or kidney disease for at least three months.Check my eligibility
What is being tested?
The study compares two vaccines: V116 and PPSV23. It aims to see if V116 triggers a better or equal immune response against pneumococcal infections in kids with higher risk of invasive disease.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site (like pain and swelling), fever, fatigue, headache, chills or muscle pain. These are common after vaccination and usually mild.

STRIDE-13 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have completed my pneumococcal vaccine course more than 8 weeks ago.

STRIDE-13 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Percentage of participants with solicited injection-site adverse events (AEs)
Percentage of participants with solicited systemic AEs
+1 more
Secondary outcome measures
GMFR from baseline in serotype-specific IgG GMCs
Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination
Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs
+2 more

Side effects data

From 2023 Phase 3 trial • 717 Patients • NCT05420961
36%
Injection site pain
14%
Fatigue
9%
Injection site swelling
8%
Injection site erythema
7%
Headache
7%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: V116
Cohort 2: V116
Cohort 3: V116
Cohort 1: PCV15
Cohort 2: PPSV23

STRIDE-13 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: V116Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1
Group II: PPSV23Active Control1 Intervention
Participants will receive a single 0.5 mL IM dose of PPSV23 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
3,910 Previous Clinical Trials
5,065,609 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,793 Previous Clinical Trials
8,067,794 Total Patients Enrolled
~547 spots leftby Feb 2025
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