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COMPLETED Phase 3

A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

NCT03620162 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Conditions Studied

Interventions

  • BIOLOGICAL V114
  • BIOLOGICAL Prevnar 13™
  • BIOLOGICAL RotaTeq™
  • BIOLOGICAL Pentacel™
  • BIOLOGICAL RECOMBIVAX HB™

Study Locations (20)

Nebraska

  • Midwest Children's Health Research Institute, LLC ( Site 0024) — Lincoln
  • Midwest Children's Health Research Institute, LLC ( Site 0003) — Lincoln
  • Midwest Children's Health Research Institute, LLC ( Site 0004) — Lincoln
  • Midwest Children's Health Research Institute, LLC ( Site 0001) — Lincoln

New York

  • Summerwood Pediatrics ( Site 0009) — Liverpool
  • University of Rochester Medical Center ( Site 0029) — Rochester
  • SUNY Upstate Medical University ( Site 0008) — Syracuse

Alabama

  • Alabama Clinical Therapeutics ( Site 0015) — Birmingham
  • Southeastern Pediatric Associates, P.A. ( Site 0002) — Dothan

South Carolina

  • Coastal Pediatric Research ( Site 0006) — Charleston
  • Parkside Pediatric ( Site 0007) — Greenville

Texas

  • Ventavia Research Group LLC ( Site 0017) — Fort Worth
  • University of Texas Medical Branch ( Site 0023) — Galveston

Arkansas

  • Children's Clinic of Jonesboro, PA ( Site 0022) — Jonesboro

Colorado

  • Davita Medical Group ( Site 0012) — Colorado Springs

Florida

  • Suncoast Research Associates, LLC ( Site 0035) — Miami

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2018-10-18
Est. Completion 2020-12-14
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 NCT03620162

The ClinicalTrials.gov registry entry for NCT03620162 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 900 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 5 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: NCT03620162 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Nebraska, New York, Alabama. 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 NCT03620162 about?

NCT03620162 is a clinical study titled "A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)". The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

What is the current status of trial NCT03620162?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2018-10-18. Estimated completion is 2020-12-14.

What conditions does trial NCT03620162 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 NCT03620162?

The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), RotaTeq™ (BIOLOGICAL), Pentacel™ (BIOLOGICAL), RECOMBIVAX HB™ (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03620162?

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 NCT03620162 being conducted?

This trial has 20 study locations across Alabama, Arkansas, Colorado, Florida, Kentucky. 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