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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: Completed Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An 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. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
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 |
What the finished NCT03620162 record still lists
NCT03620162 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 815-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (10% higher).
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 names 20 study sites across 12 states, led by 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
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 NCT03620162's enrollment target sits among peer trials
900 7th of 10 higher than 4 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
-
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
COMPLETED · Phase 3
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