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NCT01992536 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Meningococcal Disease, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
- 13
- Study locations
NCT01992536 is a Phase 2 study of Meningococcal Disease that has completed, run by Novartis Vaccines. The registered enrollment target is 194 participants, roughly in line with the 210-participant average among 3 other Meningococcal Disease trials with a reported enrollment target. The trial reports 13 study locations across 9 states.
The verdict
NCT01992536, a Phase 2 study of Meningococcal Disease, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
- 13
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 210-participant average among 3 other Meningococcal Disease trials with a reported enrollment target. The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.
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.
NCT01992536 reports 13 study locations spanning 9 distinct geographic areas - top geographies include California, Kentucky, Ohio.
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.
What interventions are being tested in trial NCT01992536?
The interventions under investigation include: Placebo (BIOLOGICAL), MenABCWY+OMV (BIOLOGICAL), MenABCWY+¼OMV (BIOLOGICAL).
Who is sponsoring clinical trial NCT01992536?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
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.
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