A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Public ClinicalTrials.gov record NCT03135834. 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, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
Study identification
- NCT ID
- NCT03135834
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,610 participants
Conditions and interventions
Conditions
Interventions
- MenABCWY Biological
- Saline Biological
- rLP2086 Biological
- MenACWY-CRM Biological
Biological
Eligibility (public fields only)
- Age range
- 10 Years to 25 Years
- 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
- Apr 24, 2017 (Actual)
- Primary completion
- Oct 25, 2022 (Actual)
- Completion
- Oct 25, 2022 (Actual)
- Last update posted
- Aug 8, 2023
2017 – 2022
United States locations
- U.S. sites
- 60
- U.S. states
- 22
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35205 | — |
| Optimal Research, LLC | Huntsville | Alabama | 35802 | — |
| Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C. | Fountain Hills | Arizona | 85268 | — |
| Clinical Research Consortium | Tempe | Arizona | 85283 | — |
| Harrisburg Family Medical Center | Harrisburg | Arkansas | 72432 | — |
| Paradigm Clinical Research Centers, Inc. | La Mesa | California | 91942 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Kaiser Permanente Santa Clara | Santa Clara | California | 95051 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Optimal Research, LLC | Melbourne | Florida | 32934 | — |
| Meridian Clinical Research LLC | Savannah | Georgia | 31406 | — |
| Optimal Research | Peoria | Illinois | 61614 | — |
| Meridian Clinical Research | Sioux City | Iowa | 51106 | — |
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | — |
| Alliance For Multispecialty Research (AMR) | Wichita | Kansas | 67207 | — |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| Horizon Research Group of Opelousas, LLC | Eunice | Louisiana | 70535 | — |
| ACC Pediatric Research | Haughton | Louisiana | 71037 | — |
| Methodist Physicians Clinic/CCT Research | Fremont | Nebraska | 68025 | — |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Meridian Clinical Research, LLC | Binghamton | New York | 13901 | — |
| United Medical Associates | Binghamton | New York | 13901 | — |
| Meridian Clinical Research, LLC | Binghamton | New York | 13905 | — |
| United Medical Associates | Binghamton | New York | 13905 | — |
| Regional Clinical Research, Inc | Endwell | New York | 13760 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| Meridian Clinical Research, LLC | Vestal | New York | 13850 | — |
| Regional Clinical Research, Inc | Vestal | New York | 13850 | — |
| Capitol Pediatrics & Adolescent Center PLLC | Raleigh | North Carolina | 27609 | — |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45246 | — |
| Velocity Clinical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | — |
| Ohio Pediatric Research Association, Inc. | Dayton | Ohio | 45414 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | — |
| Charleston Pediatrics, PA | Charleston | South Carolina | 29403 | — |
| PMG Research of Charleston, LLC | Mt. Pleasant | South Carolina | 29464 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | — |
| PMG Research of Bristol, LLC | Bristol | Tennessee | 37620 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Texas Health Care, PLLC | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Acrc Trials | Plano | Texas | 75024 | — |
| North Texas Family Medicine | Plano | Texas | 75093 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| J. Lewis Research Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | 84095 | — |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | — |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | — |
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 NCT03135834, 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 Aug 8, 2023 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03135834 live on ClinicalTrials.gov.