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Vaccine

V116 for Pneumonia

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 ~180 days
Awards & highlights

Study Summary

This trial is testing a new pneumococcal vaccine in adults over 50 who have received a pneumococcal vaccine in the past. The study will evaluate the new vaccine's safety, tolerability, and effectiveness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~180 days 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
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA

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

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3: V116Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Group II: Cohort 2: V116Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Group III: Cohort 1: V116Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Group IV: Cohort 1: PCV15Active Control1 Intervention
Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Group V: Cohort 2: PPSV23Active Control1 Intervention
Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
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
5,059,218 Total Patients Enrolled
19 Trials studying Pneumonia
421,761 Patients Enrolled for Pneumonia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,023 Total Patients Enrolled
13 Trials studying Pneumonia
3,453 Patients Enrolled for Pneumonia

Frequently Asked Questions

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

In how many different places is this trial taking place?

"This study is currently enrolling at 20 sites, which are located in Meridian, Mirabel, Birmingham and other cities. To make participation more convenient, try to select the clinical trial site that is closest to your home."

Answered by AI

How many test subjects are participating in this research?

"That is correct. The clinical trial was originally posted on 7/12/2022 and was last updated on 11/17/2022. They are looking for 700 participants from 20 different centres."

Answered by AI

What are the short and long-term effects of V116?

"V116's safety is estimated to be a 3. This Phase 3 trial means that not only does data support efficacy, but multiple trials have also shown it to be safe."

Answered by AI

Are people still able to sign-up for this experiment?

"That is correct. The listing on clinicaltrials.gov indicates that the trial administrators are still looking for volunteers. This particular trial was first posted on July 12th, 2022 and updated most recently on November 17th of the same year. They are hoping to enroll 700 individuals from 20 different locations."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
Indago Research & Health Center, Inc ( Site 0005)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
2022. "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05420961.
~261 spots leftby Apr 2025
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