A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Public ClinicalTrials.gov record NCT03692871. 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, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Study identification
- NCT ID
- NCT03692871
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,409 participants
Conditions and interventions
Conditions
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
- Dec 14, 2018 (Actual)
- Primary completion
- Mar 26, 2021 (Actual)
- Completion
- Mar 26, 2021 (Actual)
- Last update posted
- Jul 28, 2023
2018 – 2021
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Premier Health Research Center, LLC ( Site 0005) | Downey | California | 90240 | — |
| Beach Pediatrics ( Site 0040) | Huntington Beach | California | 92647 | — |
| Khruz Biotechnology Research Institute ( Site 0006) | San Diego | California | 92102 | — |
| Kaiser Permanente - San Jose ( Site 0036) | San Jose | California | 95119 | — |
| Kaiser Permanente - Santa Clara ( Site 0027) | Santa Clara | California | 95051 | — |
| Children's Research, LLC ( Site 0025) | Lake Mary | Florida | 32746 | — |
| Advanced Research For Health Improvement LLC ( Site 0030) | Naples | Florida | 34102 | — |
| Pediatric Partners, P.A. ( Site 0010) | Overland Park | Kansas | 66213 | — |
| Novak Center for Childrens Health ( Site 0033) | Louisville | Kentucky | 40202 | — |
| Medpharmics, LLC ( Site 0037) | Metairie | Louisiana | 70006 | — |
| Child Health Care Associates ( Site 0024) | East Syracuse | New York | 13057 | — |
| Primedical Clinical Research ( Site 0035) | Dayton | Ohio | 45419 | — |
| Allegheny Health & Wellness Pavilion West ( Site 0034) | Erie | Pennsylvania | 16506 | — |
| CCP- Kid's Way ( Site 0008) | Hermitage | Pennsylvania | 16148 | — |
| Thomas Jefferson University ( Site 0029) | Philadelphia | Pennsylvania | 19107 | — |
| Medical Research South, LLC ( Site 0013) | Charleston | South Carolina | 29407 | — |
| Pediatric Associates [Houston, TX] ( Site 0039) | Houston | Texas | 77087 | — |
| University of Texas Medical Branch ( Site 0018) | League City | Texas | 77573 | — |
| Tanner Clinic ( Site 0009) | Layton | Utah | 84041 | — |
| Wee Care Pediatrics ( Site 0031) | Layton | Utah | 84041 | — |
| Wee Care Pediatrics ( Site 0020) | Roy | Utah | 84067 | — |
| University of Wisconsin American Family Children's Hospital ( Site 0023) | Madison | Wisconsin | 53792 | — |
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 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03692871, 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 Jul 28, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03692871 live on ClinicalTrials.gov.