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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 months

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 2021 Phase 1 & 2 trial • 600 Patients • NCT04168190

38%

Injection site pain

16%

Headache

13%

Fatigue

10%

Myalgia

Injection site swelling

Injection site erythema

Arthralgia

100%

80%

60%

40%

20%

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-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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,326 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,399 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this research trial?

"In order to qualify for participation in this medical trial, patients must have a confirmed diagnosis of pneumococcal disease and be within the age range of 2 to 17 years old. The study aims to enroll a total of 820 participants."

Answered by AI

In how many distinct locations is this investigation currently being conducted?

"Among the various locations recruiting patients for this trial, some include Tribe Clinical Research - Spartanburg (Site 0108) situated in Spartanburg, Velocity Clinical Research, Salt Lake City (Site 0124) located in West Jordan, and Tribe Clinical Research, LLC-Pediatrics (Site 0118) based in Greenville. There are also eight other sites participating as well."

Answered by AI

What is the upper limit of participants enrolled in this medical study?

"To successfully carry out this study, a total of 820 participants who meet the inclusion criteria are needed. Merck Sharp & Dohme LLC, acting as the sponsor, will oversee the trial across multiple sites. Some notable locations include Tribe Clinical Research - Spartanburg (Site 0108) situated in Spartanburg, South carolina and Velocity Clinical Research, Salt Lake City (Site 0124) located in West Jordan, Utah."

Answered by AI

Has V116 received official approval from the FDA?

"Based on being a Phase 3 trial, which signifies the presence of efficacy data and multiple rounds of safety data, our team at Power rates the safety of V116 as a 3."

Answered by AI

Is the clinical trial open to participants who are above the age of 70?

"This clinical trial is seeking participants within the age range of 2 to 17 years old."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary outcome measure for this clinical trial is the percentage of participants experiencing vaccine-related serious adverse events (SAEs) within a 30-day period following vaccination. Secondary outcomes include determining the geometric mean fold rise (GMFR) in serotype-specific IgG geometric mean concentrations (GMCs) using pneumococcal electrochemiluminescence (PnECL). Additionally, the study will assess the GMCs of serotype-specific Immunoglobulin G (IgG) after vaccination utilizing PnECL and determine the percentage of participants with at least a four-fold increase from baseline in serotype-specific IgG GMCs"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

2024. "A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06177912.

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