Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
Public ClinicalTrials.gov record NCT03077438. 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 an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children 2 to 9 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico. Primary objective: \- To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years. Secondary objectives: * To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age. * To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. * To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. Observational objective: \- To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®.
Study identification
- NCT ID
- NCT03077438
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,000 participants
Conditions and interventions
Interventions
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Biological
- Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years to 9 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
- Feb 17, 2017 (Actual)
- Primary completion
- Oct 10, 2017 (Actual)
- Completion
- Oct 10, 2017 (Actual)
- Last update posted
- Mar 28, 2022
2017
United States locations
- U.S. sites
- 35
- U.S. states
- 16
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35205 | — |
| Investigational Site | Dothan | Alabama | 36305 | — |
| Investigational Site | Tucson | Arizona | 85741 | — |
| Investigational Site | Jonesboro | Arkansas | 72401 | — |
| Investigational Site | Anaheim | California | 92804 | — |
| Investigational Site | Downey | California | 90241 | — |
| Investigational Site | Paramount | California | 90723 | — |
| Investigational Site | San Diego | California | 92103 | — |
| Investigational Site | Council Bluffs | Iowa | 51503 | — |
| Investigational Site | Bardstown | Kentucky | 40004 | — |
| Investigational Site | Nicholasville | Kentucky | 40356 | — |
| Investigational Site | Metairie | Louisiana | 70006 | — |
| Investigational Site | Woburn | Massachusetts | 01801 | — |
| Investigational Site | Bridgeton | Missouri | 63044 | — |
| Investigational Site | Kansas City | Missouri | 64114 | — |
| Investigational Site | Omaha | Nebraska | 68134 | — |
| Investigational Site | Cincinnati | Ohio | 45245 | — |
| Investigational Site | Cleveland | Ohio | 44121 | — |
| Investigational Site | Dayton | Ohio | 45414 | — |
| Investigational Site | Fairfield | Ohio | 45014 | — |
| Investigational Site | Grants Pass | Oregon | 97527 | — |
| Investigational Site | Gresham | Oregon | 92103 | — |
| Investigational Site | Erie | Pennsylvania | 16506 | — |
| Investigational Site | Hermitage | Pennsylvania | 16148 | — |
| Investigational Site | Goodlettsville | Tennessee | 37072 | — |
| Investigational Site | Tullahoma | Tennessee | 37388 | — |
| Investigational Site | Layton | Utah | 84041 | — |
| Investigational Site | Orem | Utah | 84057 | — |
| Investigational Site | Roy | Utah | 84067 | — |
| Investigational Site | Salt Lake City | Utah | 84109 | — |
| Investigational Site | Salt Lake City | Utah | 84121 | — |
| Investigational Site | South Jordan | Utah | 84095 | — |
| Investigational Site | Syracuse | Utah | 84075 | — |
| Investigational Site | West Jordan | Utah | 848088 | — |
| Investigational Site | Midlothian | Virginia | 23113 | — |
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 NCT03077438, 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 Mar 28, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03077438 live on ClinicalTrials.gov.