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NCT03620162 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
- 20
- Study locations
NCT03620162 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 900 participants, above the 815-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT03620162, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2020-12-14 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 815-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (10% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT03620162 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Nebraska, New York, Alabama.
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.
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).
Who is sponsoring clinical trial NCT03620162?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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