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Conjugate Vaccine

V116 for Pneumococcal Diseases

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~6 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new pneumococcal vaccine in young adults.

Eligible Conditions
  • Pneumococcal Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~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 titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116
Percentage of participants with solicited injection-site adverse events (AEs)
Percentage of participants with solicited systemic AEs
+1 more
Secondary outcome measures
Immunoglobulin G
Immunoglobulin G
Vaccination
+5 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

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: V116 Lot 3Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
Group II: V116 Lot 2Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
Group III: V116 Lot 1Experimental Treatment1 Intervention
Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
Group IV: 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
3,888 Previous Clinical Trials
5,052,921 Total Patients Enrolled
5 Trials studying Pneumococcal Diseases
2,407 Patients Enrolled for Pneumococcal Diseases
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,061,726 Total Patients Enrolled
7 Trials studying Pneumococcal Diseases
3,112 Patients Enrolled for Pneumococcal Diseases

Frequently Asked Questions

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

Are there any specific medical requirements for this clinical trial?

"This study is enrolling 2040 individuals that have contracted pneumococcal diseases and are between 18-49 years old. There are several key inclusion criteria that potential patients must meet."

Answered by AI

How many people can join this clinical trial at the most?

"To meet the requirements of this clinical study, 2040 individuals must be enrolled. These participants must adhere to specific inclusion criteria and can sign up at locations such as Lynn Health Science Institute (Site 0014) in Oklahoma City, OK or Clinical Research Prime Rexburg (Site 0040) in Rexburg, ID."

Answered by AI

In how many different places is this trial being run today?

"Currently, this 38 clinical trial sites are looking for participants including Lynn Health Science Institute ( Site 0014) in Oklahoma City, Clinical Research Prime Rexburg ( Site 0040) in Rexburg, and IMA Clinical Research San Antonio ( Site 0020) in San Antonio."

Answered by AI

Are there any unfilled slots in this clinical trial?

"That is accurate. The information available on clinicaltrials.gov shows that the trial began recruiting on 8/12/2022 and has since been updated on 11/17/2022. They are looking for 2040 participants across 38 different centres."

Answered by AI

For this particular test, are elderly patients being sought out?

"This study is aiming to enroll individuals who are between the ages of 18-49."

Answered by AI

What are the aims of this clinical trial?

"The primary outcome of this trial will be percentage of participants with vaccine-related serious adverse events (SAEs). The trial will last up to 5 days, and secondary outcomes include GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots, GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™, and Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with"

Answered by AI

What are the possible dangers associated with V116?

"V116 received a score of 3 on Power's safety scale. This is because V116 is in Phase 3 clinical trials, meaning that there is some data to support its efficacy and multiple rounds of data supporting its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
2022. "A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05464420.
~811 spots leftby Apr 2025
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