Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Public ClinicalTrials.gov record NCT03893448. 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, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
Study identification
- NCT ID
- NCT03893448
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,720 participants
Conditions and interventions
Conditions
Interventions
- V114 Biological
- Prevnar 13™ Biological
- RotaTeq™ Biological
- Pentacel™ Biological
- RECOMBIVAX HB™ Biological
- VAQTA™ Biological
- MMR II™ Biological
- VARIVAX™ Biological
- HIBERIX™ 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
- Jun 19, 2019 (Actual)
- Primary completion
- May 24, 2021 (Actual)
- Completion
- May 24, 2021 (Actual)
- Last update posted
- Jul 28, 2023
2019 – 2021
United States locations
- U.S. sites
- 66
- U.S. states
- 24
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics ( Site 0159) | Birmingham | Alabama | 35205 | — |
| Southeastern Pediatric Associates, P.A. ( Site 0107) | Dothan | Alabama | 36305 | — |
| South Alabama Pediatrics ( Site 0263) | Opp | Alabama | 36467 | — |
| Northwest Arkansas Pediatric Clinic ( Site 0172) | Fayetteville | Arkansas | 72703 | — |
| Children's Clinic of Jonesboro, PA ( Site 0184) | Jonesboro | Arkansas | 72401 | — |
| Advanced Clinical Research - Rancho Paseo ( Site 0163) | Banning | California | 92220 | — |
| Altissima Clinical Research LLC ( Site 0213) | Bellflower | California | 90706 | — |
| Southland Clinical Research Center ( Site 0187) | Bellflower | California | 90706 | — |
| Premier Health Research Center, LLC ( Site 0121) | Downey | California | 90240 | — |
| Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282) | Oakland | California | 94612 | — |
| Kaiser Permanente - Sacramento ( Site 0257) | Sacramento | California | 95815 | — |
| Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256) | Sacramento | California | 95823 | — |
| Kaiser Permanente - San Jose ( Site 0258) | San Jose | California | 95119 | — |
| Kaiser Permanente - Santa Clara ( Site 0244) | Santa Clara | California | 95051 | — |
| Davita Medical Group ( Site 0141) | Colorado Springs | Colorado | 80922 | — |
| Suncoast Research Associates, LLC ( Site 0250) | Miami | Florida | 33184 | — |
| Suncoast Research Associates, LLC ( Site 0249) | North Miami Beach | Florida | 33160 | — |
| Children's Health Center ( Site 0272) | Tampa | Florida | 33617 | — |
| Saltzer Medical Group ( Site 0215) | Nampa | Idaho | 83686 | — |
| Kentucky Pediatric/Adult Research Inc ( Site 0136) | Bardstown | Kentucky | 40004 | — |
| Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276) | Nicholasville | Kentucky | 40356 | — |
| ACC Pediatric Research ( Site 0147) | Haughton | Louisiana | 71037 | — |
| Medpharmics, LLC ( Site 0157) | Metairie | Louisiana | 70006 | — |
| Virgo-Carter Pediatrics ( Site 0275) | Silver Spring | Maryland | 20910 | — |
| Tufts Medical Center-Floating Hospital for Children ( Site 0129) | Boston | Massachusetts | 02111 | — |
| Pediatric Associates of Fall River ( Site 0183) | Fall River | Massachusetts | 02721 | — |
| MediSync Clinical Research Hattiesburg Clinic ( Site 0259) | Petal | Mississippi | 39465 | — |
| Children's Mercy Clinics on Broadway ( Site 0171) | Kansas City | Missouri | 64111 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0109) | Lincoln | Nebraska | 68505 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0106) | Lincoln | Nebraska | 68522 | — |
| Children's Physicians, UNMC ( Site 0252) | Omaha | Nebraska | 68198 | — |
| Southwest CARE Center ( Site 0161) | Santa Fe | New Mexico | 87501 | — |
| Child Health Care Associates ( Site 0242) | East Syracuse | New York | 13057 | — |
| Child Health Care Associates ( Site 0267) | Liverpool | New York | 13090 | — |
| Advantage Clinical Trials ( Site 0274) | The Bronx | New York | 10468 | — |
| Haywood Pediatric and Adolescent Medicine Group ( Site 0248) | Clyde | North Carolina | 28721 | — |
| Capitol Pediatrics & Adolescent Center ( Site 0223) | Raleigh | North Carolina | 27609 | — |
| Senders Pediatrics ( Site 0190) | Cleveland | Ohio | 44121 | — |
| Dayton Clinical Research ( Site 0188) | Dayton | Ohio | 45406 | — |
| Cyn3rgy Research ( Site 0246) | Gresham | Oregon | 97030 | — |
| Pediatric Medical Associates ( Site 0239) | East Norriton | Pennsylvania | 19401 | — |
| Allegheny Health & Wellness Pavilion West ( Site 0210) | Erie | Pennsylvania | 16506 | — |
| Lockman & Lubell Pediatrics ( Site 0166) | Fort Washington | Pennsylvania | 19034 | — |
| CCP- Kid's Way ( Site 0130) | Hermitage | Pennsylvania | 16148 | — |
| Palmetto Pediatrics, PA ( Site 0164) | Charleston | South Carolina | 29406-9170 | — |
| Cheraw Pediatrics ( Site 0280) | Cheraw | South Carolina | 29520 | — |
| Parkside Pediatric ( Site 0125) | Greenville | South Carolina | 29607 | — |
| Holston Medical Group ( Site 0165) | Kingsport | Tennessee | 37660 | — |
| DFW Clinical Research ( Site 0111) | Dallas | Texas | 75234 | — |
| University of Texas Medical Branch ( Site 0185) | Galveston | Texas | 77555 | — |
| Ventavia Research Group LLC ( Site 0142) | Houston | Texas | 77008 | — |
| Pediatric Associates ( Site 0209) | Houston | Texas | 77087 | — |
| Houston Clinical Research Network ( Site 0266) | Houston | Texas | 77090 | — |
| Ventavia Research Group LLC ( Site 0139) | Keller | Texas | 76248 | — |
| FMC Science ( Site 0115) | Lampasas | Texas | 76550 | — |
| University of Texas Medical Branch ( Site 0170) | League City | Texas | 77573 | — |
| DCOL Center for Clinical Research ( Site 0247) | Longview | Texas | 75605 | — |
| Wee Care Pediatrics ( Site 0154) | Layton | Utah | 84041 | — |
| Cottonwood Pediatrics ( Site 0153) | Murray | Utah | 84107 | — |
| Pediatric Care ( Site 0138) | Provo | Utah | 84604 | — |
| Wee Care Pediatrics-Roy ( Site 0174) | Roy | Utah | 84067 | — |
| University of Utah ( Site 0214) | Salt Lake City | Utah | 84113 | — |
| Dixie Pediatrics ( Site 0260) | St. George | Utah | 84790 | — |
| Wee Care Pediatrics ( Site 0193) | Syracuse | Utah | 84075 | — |
| MultiCare Rockwood Cheney Clinic ( Site 0195) | Cheney | Washington | 99004 | — |
| Multicare / Rockwood Clinic ( Site 0167) | 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 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03893448, 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 NCT03893448 live on ClinicalTrials.gov.