Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
Public ClinicalTrials.gov record NCT02752906. 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
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years. Primary Objective: * To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose. Secondary Objectives: * To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants. * To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination. Observational Objectives: * To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination. * To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants. * To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.
Study identification
- NCT ID
- NCT02752906
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 810 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
- 15 Years and older
- 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 15, 2016 (Actual)
- Primary completion
- Dec 19, 2016 (Actual)
- Completion
- Dec 19, 2016 (Actual)
- Last update posted
- Apr 5, 2022
2016
United States locations
- U.S. sites
- 29
- U.S. states
- 16
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 016 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 032 | Dothan | Alabama | 36305 | — |
| Investigational Site Number 026 | Mesa | Arizona | 85213 | — |
| Investigational Site Number 022 | Jonesboro | Arkansas | 72401 | — |
| Investigational Site Number 005 | Downey | California | 90241 | — |
| Investigational Site Number 014 | La Puente | California | 91744 | — |
| Investigational Site Number 029 | San Diego | California | 92108 | — |
| Investigational Site Number 001 | San Diego | California | 92123-1881 | — |
| Investigational Site Number 013 | Bardstown | Kentucky | 40004 | — |
| Investigational Site Number 027 | Nicholasville | Kentucky | 40356 | — |
| Investigational Site Number 015 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 018 | Woburn | Massachusetts | 01801 | — |
| Investigational Site Number 010 | Troy | Michigan | 48098 | — |
| Investigational Site Number 008 | Kansas City | Missouri | 64114 | — |
| Investigational Site Number 028 | St Louis | Missouri | 63141 | — |
| Investigational Site Number 023 | Lincoln | Nebraska | 68504 | — |
| Investigational Site Number 031 | Omaha | Nebraska | 68144 | — |
| Investigational Site Number 006 | Rochester | New York | 14609 | — |
| Investigational Site Number 012 | Fargo | North Dakota | 58104 | — |
| Investigational Site Number 019 | Cincinnati | Ohio | 45245 | — |
| Investigational Site Number 011 | Fairfield | Ohio | 45014 | — |
| Investigational Site Number 025 | Huber Heights | Ohio | 45424 | — |
| Investigational Site Number 021 | Kettering | Ohio | 45429 | — |
| Investigational Site Number 009 | Erie | Pennsylvania | 16508 | — |
| Investigational Site Number 007 | Hermitage | Pennsylvania | 16148 | — |
| Investigational Site Number 024 | Tullahoma | Tennessee | 37388 | — |
| Investigational Site Number 020 | Salt Lake City | Utah | 84109 | — |
| Investigational Site Number 003 | Salt Lake City | Utah | 84121 | — |
| Investigational Site Number 017 | 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02752906, 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 Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02752906 live on ClinicalTrials.gov.