Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
Public ClinicalTrials.gov record NCT02842853. 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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55 years of age in the United States (US). Primary Objectives: * To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs). * To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®. Secondary Objective: * To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adult population (18 to 55 years old). * To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adolescent population (10 to 17 years old). * To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination. * To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of Menactra®. Observational Objectives: * To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed Menactra®.
Study identification
- NCT ID
- NCT02842853
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,344 participants
Conditions and interventions
Interventions
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Biological
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 10 Years to 55 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
- Jul 15, 2016 (Actual)
- Primary completion
- Feb 28, 2017 (Actual)
- Completion
- Feb 28, 2017 (Actual)
- Last update posted
- Apr 5, 2022
2016 – 2017
United States locations
- U.S. sites
- 89
- U.S. states
- 25
- U.S. cities
- 75
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35205 | — |
| Not listed | Dothan | Alabama | 36305 | — |
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Glendale | Arizona | 85308 | — |
| Not listed | Mesa | Arizona | 85213 | — |
| Not listed | Phoenix | Arizona | 85018 | — |
| Not listed | Harrisburg | Arkansas | 72432 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Anaheim | California | 92804 | — |
| Not listed | Downey | California | 90241 | — |
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Redding | California | 96001 | — |
| Not listed | Sacramento | California | 95825 | — |
| Not listed | San Diego | California | 92102 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | San Diego | California | 96001 | — |
| Not listed | Santa Rosa | California | 95405 | — |
| Not listed | Upland | California | 91786 | — |
| Not listed | West Covina | California | 91790 | — |
| Not listed | Littleton | Colorado | 80128 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Hialeah | Florida | 33012 | — |
| Not listed | Hialeah | Florida | 33016 | — |
| Not listed | Miami | Florida | 33142 | — |
| Not listed | Orlando | Florida | 32806 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | St. Petersburg | Florida | 33710 | — |
| Not listed | West Palm Beach | Florida | 33409 | — |
| Not listed | Savannah | Georgia | 31406 | — |
| Not listed | Meridian | Idaho | 83642 | — |
| Not listed | Council Bluffs | Iowa | 51503 | — |
| Not listed | Lenexa | Kansas | 66219 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Park City | Kansas | 67219 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Wichita | Kansas | 67207 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Bridgeton | Missouri | 63044 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Lincoln | Nebraska | 60505 | — |
| Not listed | Lincoln | Nebraska | 68522 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Omaha | Nebraska | 68134 | — |
| Not listed | Charlotte | North Carolina | 28209 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Salisbury | North Carolina | 28144 | — |
| Not listed | Fargo | North Dakota | 58104 | — |
| Not listed | Cincinnati | Ohio | 45245 | — |
| Not listed | Cincinnati | Ohio | 45246 | — |
| Not listed | Cleveland | Ohio | 44122 | — |
| Not listed | Dayton | Ohio | 45414 | — |
| Not listed | Dayton | Ohio | 45419 | — |
| Not listed | Corvallis | Oregon | 97330 | — |
| Not listed | Grants Pass | Oregon | 97527 | — |
| Not listed | Erie | Pennsylvania | 16505 | — |
| Not listed | Hermitage | Pennsylvania | 16148 | — |
| Not listed | McMurray | Pennsylvania | 15317 | — |
| Not listed | Upper Saint Clair | Pennsylvania | 15241 | — |
| Not listed | Warwick | Rhode Island | 02886 | — |
| Not listed | Charleston | South Carolina | 29407 | — |
| Not listed | Charleston | South Carolina | 29414 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Jackson | Tennessee | 38305 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Tullahoma | Tennessee | 37388 | — |
| Not listed | Corpus Christi | Texas | 78413 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Waxahachie | Texas | 75165 | — |
| Not listed | Draper | Utah | 84020 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Murray | Utah | 84123 | — |
| Not listed | Orem | Utah | 84058 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | South Jordan | Utah | 84095 | — |
| Not listed | West Jordan | Utah | 83642 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Burke | Virginia | 22015 | — |
| Not listed | Charlottesville | Virginia | 22911 | — |
| Not listed | Charlottesville | Virginia | 29902 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02842853, 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 5, 2022 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02842853 live on ClinicalTrials.gov.