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NCT03615482 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT03615482: Completed Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
NCT03615482 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, above the 785-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03615482, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection-site AEs included injection-site erythema /redness, pain /tendernes
Conditions Studied
Interventions
- BIOLOGICAL V114
- BIOLOGICAL QIV
- BIOLOGICAL Matching Placebo for V114
Study Locations (20)
California
- Southland Clinical Research Center ( Site 0033) - Fountain Valley
- Valley Clinical Trials Inc. ( Site 0001) - Northridge
- Center for Clinical Trials, LLC ( Site 0025) - Paramount
- Artemis Institute for Clinical Research ( Site 0026) - San Diego
- California Research Foundation ( Site 0002) - San Diego
- Bayview Research Group, LLC ( Site 0010) - Valley Village
Florida
- Indago Research & Health Center, Inc ( Site 0007) - Hialeah
- Research Centers of America, LLC ( Site 0036) - Hollywood
- Suncoast Research Group, LLC ( Site 0020) - Miami
- L&C Professional Medical Research Institute ( Site 0015) - Miami
- Alpha Science Research ( Site 0018) - Miami
- Lakes Research LLC ( Site 0034) - Miami Lakes
Arizona
- Synexus Clinical Research US, Inc. ( Site 0039) - Chandler
- Synexus Clinical Research, US,Inc/Central Arizona Medical Associates, PC ( Site 0004) - Mesa
- Synexus Clinical Research US, Inc. ( Site 0042) - Scottsdale
Illinois
- Evanston Premier Healthcare & Research, LLC. ( Site 0012) - Evanston
- Healthcare Research Network LLC ( Site 0006) - Flossmoor
- Springfield Clinic ( Site 0045) - Springfield
Alabama
- Achieve Clinical Research, LLC ( Site 0046) - Birmingham
Colorado
- Synexus Clinical Research US, Inc./Colorado Springs Family Practice ( Site 0021) - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2019-06-24 |
| Phase | Phase 3 |
What the finished NCT03615482 record still lists
NCT03615482 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 785-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (53% higher).
The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 3 interventions - of which V114 is the first listed.
NCT03615482 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03615482 about?
NCT03615482 is a clinical study titled "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)". This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the a...
What is the current status of trial NCT03615482?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2018-09-14. Estimated completion is 2019-06-24.
What conditions does trial NCT03615482 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT03615482?
The interventions under investigation include: V114 (BIOLOGICAL), QIV (BIOLOGICAL), Matching Placebo for V114 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03615482?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03615482 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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 NCT03615482's enrollment target sits among peer trials
1,200 4th of 10 higher than 7 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 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
-
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
COMPLETED · Phase 3
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