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COMPLETED 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)

NCT03615482 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,200 participants
Start Date 2018-09-14
Est. Completion 2019-06-24
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03615482

The ClinicalTrials.gov registry entry for NCT03615482 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03615482 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03615482?

The interventions under investigation include: V114 (BIOLOGICAL), QIV (BIOLOGICAL), Matching Placebo for V114 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03615482?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial