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COMPLETED Phase 2

Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

NCT01992536 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects. In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102\_03E1.

Conditions Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL MenABCWY+OMV
  • BIOLOGICAL MenABCWY+¼OMV

Study Locations (13)

California

  • Site 24, Madera Family Medical Group 1111 West 4th Street — Madera
  • Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301 — Paramount

Kentucky

  • Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street — Bardstown
  • Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2 — Louisville

Ohio

  • Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200 — Dayton
  • Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive — Kettering

Kraków

  • Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska — Ul. Braci Kiemliczów 14
  • Site 12, NZOZ PRAKTIMED Sp.zo.o — ul.Strzelców 15

Alabama

  • Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 — Birmingham

Tennessee

  • Site 22, Focus Research Group 201 Signature Place — Lebanon

Izabelin

  • Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c. — ul.Kościuszki 41

Warszawa

  • Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański — Ul. Cegłowska 80

Trial Details

FieldValue
Enrollment Target 194 participants
Start Date 2013-12
Est. Completion 2015-04
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 NCT01992536

The ClinicalTrials.gov registry entry for NCT01992536 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 194 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 Meningococcal Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT01992536 reports 13 study locations spanning 9 distinct geographic areas — top geographies include California, Kentucky, Ohio. 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 NCT01992536 about?

NCT01992536 is a clinical study titled "Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)". The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180) (Group...

What is the current status of trial NCT01992536?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2013-12. Estimated completion is 2015-04.

What conditions does trial NCT01992536 study?

This clinical trial studies the following conditions: 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 NCT01992536?

The interventions under investigation include: Placebo (BIOLOGICAL), MenABCWY+OMV (BIOLOGICAL), MenABCWY+¼OMV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01992536?

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 NCT01992536 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