A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Public ClinicalTrials.gov record NCT03620162. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03620162
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 900 participants
Conditions and interventions
Conditions
Interventions
- Prevnar 13™ Biological
- V114 Biological
- RotaTeq™ Biological
- Pentacel™ Biological
- RECOMBIVAX HB™ Biological
- HIBERIX™ Biological
- M-M-R™ II Biological
- VARIVAX™ Biological
Biological
Eligibility (public fields only)
- Age range
- 42 Days to 90 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 18, 2018 (Actual)
- Primary completion
- Dec 14, 2020 (Actual)
- Completion
- Dec 14, 2020 (Actual)
- Last update posted
- Jan 17, 2023
2018 – 2020
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics ( Site 0015) | Birmingham | Alabama | 35205 | — |
| Southeastern Pediatric Associates, P.A. ( Site 0002) | Dothan | Alabama | 36305 | — |
| Children's Clinic of Jonesboro, PA ( Site 0022) | Jonesboro | Arkansas | 72401 | — |
| Davita Medical Group ( Site 0012) | Colorado Springs | Colorado | 80922 | — |
| Suncoast Research Associates, LLC ( Site 0035) | Miami | Florida | 33184 | — |
| Kentucky Pediatric/Adult Research Inc ( Site 0011) | Bardstown | Kentucky | 40004 | — |
| Pediatric Associates of Fall River ( Site 0021) | Fall River | Massachusetts | 02721 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0024) | Lincoln | Nebraska | 68504 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0003) | Lincoln | Nebraska | 68505 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0004) | Lincoln | Nebraska | 68516 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0001) | Lincoln | Nebraska | 68522 | — |
| Summerwood Pediatrics ( Site 0009) | Liverpool | New York | 13088 | — |
| University of Rochester Medical Center ( Site 0029) | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University ( Site 0008) | Syracuse | New York | 13202 | — |
| Piedmont Healthcare, PA ( Site 0025) | Statesville | North Carolina | 28625 | — |
| Coastal Pediatric Research ( Site 0006) | Charleston | South Carolina | 29414 | — |
| Parkside Pediatric ( Site 0007) | Greenville | South Carolina | 29607 | — |
| Holston Medical Group ( Site 0018) | Kingsport | Tennessee | 37660 | — |
| Ventavia Research Group LLC ( Site 0017) | Fort Worth | Texas | 76104 | — |
| University of Texas Medical Branch ( Site 0023) | Galveston | Texas | 77555 | — |
| Wasatch Pediatrics-Cottonwood Office ( Site 0014) | Murray | Utah | 84107 | — |
| Multicare ( Site 0019) | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03620162, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 17, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03620162 live on ClinicalTrials.gov.