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NCT03950622 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,205
- Enrollment target
- 20
- Study locations
NCT03950622: Completed Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
NCT03950622 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,205 participants, above the 784-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03950622, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,205 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain.
Conditions Studied
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13®
Study Locations (20)
Florida
- Indago Research & Health Center, Inc ( Site 1002) - Hialeah
- Research Centers of America, LLC ( Site 1014) - Hollywood
- Advanced Medical Research Institute ( Site 0117) - Miami
- Lakes Research LLC ( Site 1005) - Miami Lakes
Ontario
- Milestone Research ( Site 2003) - London
- Bluewater Clinical Research Group Inc ( Site 2004) - Sarnia
- Manna Research Inc.. ( Site 2007) - Toronto
Texas
- Diagnostics Research Group ( Site 1000) - San Antonio
- Synexus ( Site 1009) - San Antonio
Virginia
- Charlottesville Medical Research Center, LLC ( Site 1003) - Charlottesville
- Health Research of Hampton Roads, Inc. ( Site 1007) - Newport News
Quebec
- Dynamik Research ( Site 2000) - Pointe-Claire
- Q & T Research Sherbrooke Inc. ( Site 2001) - Sherbrooke
Arizona
- Synexus ( Site 1001) - Mesa
California
- Artemis Institute for Clinical Research ( Site 1012) - San Diego
Kansas
- Alliance for Multispecialty Research, LLC ( Site 1008) - Newton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,205 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 3 |
What the finished NCT03950622 record still lists
NCT03950622 is an interventional study that assigns participants to a tested intervention. Its 1,205 participants enrollment target places it among the larger protocols in the corpus, above the 784-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (54% higher).
The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 2 interventions - of which V114 is the first listed.
NCT03950622 names 20 study sites across 12 states, led by Florida, Ontario, Texas.
Frequently Asked Questions
What is clinical trial NCT03950622 about?
NCT03950622 is a clinical study titled "Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)". The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsono...
What is the current status of trial NCT03950622?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,205 participants. The study started on 2019-06-13. Estimated completion is 2020-03-30.
What conditions does trial NCT03950622 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT03950622?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13® (BIOLOGICAL).
Who is sponsoring clinical trial NCT03950622?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03950622 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pneumococcal Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03950622's enrollment target sits among peer trials
1,205 3rd of 10 higher than 8 of 10 other Pneumococcal Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pneumococcal Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)
COMPLETED · Phase 3
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
COMPLETED · Phase 3
-
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
COMPLETED · Phase 3
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
COMPLETED · Phase 3
-
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
COMPLETED · Phase 3
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