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NCT01272180 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
A Phase 2 study of Invasive Meningococcal Disease, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 484
- Enrollment target
- 13
- Study locations
NCT01272180: Completed Phase 2 study of Invasive Meningococcal Disease, sponsored by Novartis Vaccines.
NCT01272180 is a Phase 2 study of Invasive Meningococcal Disease that has completed, run by Novartis Vaccines. The registered enrollment target is 484 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (264% higher). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01272180, a Phase 2 study of Invasive Meningococcal Disease, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 484 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
Primary Outcome
Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination tite
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
- BIOLOGICAL Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
- BIOLOGICAL Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
- BIOLOGICAL Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Study Locations (13)
Other
- Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41 - Izabelin (Warszawa)
- NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12 - Krakow
- NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15 - Krakow
- Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80 - Warsaw
- Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44 - Wroclaw
California
- Madera Family Medical Group,1111 West 4th Street - Madera
- Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301 - Paramount
Kentucky
- Kentucky Pediatric/Adult Research, 201 south 5th street - Bardstown
- Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2 - Louisville
Ohio
- Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C - Huber Heights
- Ohio Pediatric Research Association, 1775 Delco Park Drive - Kettering
Alabama
- Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615 - Birmingham
Tennessee
- Focus Research Group,201 Signature Place - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT01272180 record still lists
NCT01272180 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (264% higher).
The record links to 1 condition, with Invasive Meningococcal Disease appearing as the primary indexed condition, and to 4 interventions - of which Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV. is the first listed.
NCT01272180 lists 13 locations in 6 states (Other, California, Kentucky).
Frequently Asked Questions
What is clinical trial NCT01272180 about?
NCT01272180 is a clinical study titled "Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults". This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
What is the current status of trial NCT01272180?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 484 participants. The study started on 2011-08. Estimated completion is 2012-09.
What conditions does trial NCT01272180 study?
This clinical trial studies the following conditions: Invasive Meningococcal Disease.
What interventions are being tested in trial NCT01272180?
The interventions under investigation include: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV. (BIOLOGICAL), Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV. (BIOLOGICAL), Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. (BIOLOGICAL), Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV. (BIOLOGICAL).
Who is sponsoring clinical trial NCT01272180?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01272180 being conducted?
This trial has 13 study locations across Alabama, California, Kentucky, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01272180's enrollment target sits among peer trials
484 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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