Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Public ClinicalTrials.gov record NCT02199691. 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 II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
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 vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This study also evaluated the immunogenicity and safety of MenACYW Conjugate vaccine when given alone compared to when given concomitantly with tetanus, diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine. Primary objective: * To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was given alone. Secondary objective: * To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines, compared to those when it was given alone. * To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine was given with HPV vaccine only. * To evaluate the antibody responses to the antigens present in HPV vaccine after the 3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine is given with Tdap vaccine only. Observational objective: * To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV vaccines.
Study identification
- NCT ID
- NCT02199691
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,715 participants
Conditions and interventions
Interventions
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine Biological
- Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Biological
- Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Biological
- GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Biological
Biological
Eligibility (public fields only)
- Age range
- 10 Years to 17 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 21, 2014
- Primary completion
- Oct 1, 2015
- Completion
- Oct 1, 2015
- Last update posted
- Apr 3, 2022
2014 – 2015
United States locations
- U.S. sites
- 35
- U.S. states
- 15
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35235 | — |
| Not listed | Huntsville | Alabama | 35802 | — |
| Not listed | Downey | California | 90241 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | Miami Beach | Florida | 33141 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Nicholasville | Kentucky | 40356 | — |
| Not listed | Columbia | Maryland | 21075 | — |
| Not listed | Lincoln | Nebraska | 68504 | — |
| Not listed | Lincoln | Nebraska | 68505 | — |
| Not listed | Lincoln | Nebraska | 68516 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Dayton | Ohio | 45414 | — |
| Not listed | Norman | Oklahoma | 73069 | — |
| Not listed | Erie | Pennsylvania | 16505 | — |
| Not listed | Charleston | South Carolina | 29414 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Tullahoma | Tennessee | 37388 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Orem | Utah | 84057 | — |
| Not listed | Payson | Utah | 84651 | — |
| Not listed | Provo | Utah | 84064 | — |
| Not listed | Roy | Utah | 84067 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
| Not listed | South Jordan | Utah | 84095 | — |
| Not listed | Spanish Fork | Utah | 84660 | — |
| Not listed | Syracuse | Utah | 84075 | — |
| Not listed | West Haven | Utah | 84401 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Charlottesville | Virginia | 22902 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Spokane | Washington | 99204 | — |
| Not listed | Spokane | Washington | 99218 | — |
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 NCT02199691, 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 3, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02199691 live on ClinicalTrials.gov.