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COMPLETED Phase 2

Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

NCT01272180 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

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

FieldValue
Enrollment Target 484 participants
Start Date 2011-08
Est. Completion 2012-09
Phase Phase 2

Sponsor

Novartis Vaccines

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01272180

The ClinicalTrials.gov registry entry for NCT01272180 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Vaccines, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01272180 reports 13 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01272180?

This trial is sponsored by Novartis Vaccines, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial