MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Public ClinicalTrials.gov record NCT04440163. 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 TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.
Study identification
- NCT ID
- NCT04440163
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,431 participants
Conditions and interventions
Conditions
Interventions
- MenABCWY Biological
- Saline Biological
- Trumenba 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
- Jun 16, 2020
- Primary completion
- Jul 23, 2022
- Completion
- Jul 23, 2022
- Last update posted
- Apr 17, 2023
2020 – 2022
United States locations
- U.S. sites
- 61
- U.S. states
- 23
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites | Birmingham | Alabama | 35205 | — |
| Central Research Associates, Inc. | Birmingham | Alabama | 35205 | — |
| Fiel Family and Sports Medicine, PC/CCT Research | Tempe | Arizona | 85283 | — |
| Velocity Clinical Research (Banning) | Banning | California | 92220 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials | Paramount | California | 90723 | — |
| Optumcare Colorado Springs, LLC | Colorado Springs | Colorado | 80922 | — |
| ALL Medical Research, LLC | Cooper City | Florida | 33024 | — |
| Alliance for MultiSpecialty Research, LLC - Miami | Coral Gables | Florida | 33134 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | — |
| Healthy Life Research, Inc. | Miami | Florida | 33175 | — |
| Bio-Medical Research, LLC | Miami | Florida | 33184 | — |
| Crystal Biomedical Research, LLC | Miami Lakes | Florida | 33014 | — |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | — |
| Complete Health Research | Ormond Beach | Florida | 32174 | — |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | — |
| PAS Research | Tampa | Florida | 33613 | — |
| Tekton Research, Inc. | Chamblee | Georgia | 30341 | — |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | — |
| Saltzer Health | Nampa | Idaho | 83686 | — |
| MOC Research | Mishawaka | Indiana | 46544 | — |
| The South Bend Clinic Center for Research | South Bend | Indiana | 46617 | — |
| The Iowa Clinic | Ankeny | Iowa | 50023 | — |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| Alliance for Multispecialty Research, LLC | El Dorado | Kansas | 67042 | — |
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | — |
| Michael W. Simon, MD, PSC | Lexington | Kentucky | 40517 | — |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70806 | — |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70809 | — |
| Acorn to Oak Pediatrics - ACC Pediatric Research | Haughton | Louisiana | 71037 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Skyline Medical Center, PC/CCT Research | Elkhorn | Nebraska | 68022 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Meridian Clinical Research, LLC | Binghamton | New York | 13901 | — |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Accellacare - Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Velocity Clinical Research - Cleveland | Cleveland | Ohio | 44122 | — |
| Dayton Clinical Research | Dayton | Ohio | 45409 | — |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Lynn Institute of Norman | Norman | Oklahoma | 73072 | — |
| Tekton Research | Yukon | Oklahoma | 73099 | — |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Accellacare US Inc. | Mt. Pleasant | South Carolina | 29464 | — |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Family Medicine Associates of Texas | Carrollton | Texas | 75010 | — |
| AIM Trials, LLC | Plano | Texas | 75093 | — |
| North Texas Family Medicine | Plano | Texas | 75093 | — |
| Tekton Research | San Antonio | Texas | 78229 | — |
| Olympus Family Medicine/CCT Research | Holladay | Utah | 84117 | — |
| Pediatric Care | Provo | Utah | 84604 | — |
| 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 | — |
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 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04440163, 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 Apr 17, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04440163 live on ClinicalTrials.gov.