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Completed Phase 3 Interventional Accepts healthy volunteers Results available

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

ClinicalTrials.gov ID: NCT01352793

Public ClinicalTrials.gov record NCT01352793. 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.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 11:12 PM EDT

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 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Study identification

NCT ID
NCT01352793
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
5,715 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
10 Years to 25 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
Nov 2012 (Type not available)
Primary completion
Sep 2014 (Actual)
Completion
Sep 2014 (Actual)
Last update posted
Mar 11, 2015

2012 – 2014

United States locations

U.S. sites
39
U.S. states
16
U.S. cities
31
Facility City State ZIP Site status
Accelovance,Inc. Huntsville Alabama 35802 —
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC Chandler Arizona 85224 —
Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC Chandler Arizona 85224 —
Cassidy Medical Group/Clinical Research Advantage Tempe Arizona 85282 —
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC Tempe Arizona 85282 —
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address Tempe Arizona 85282 —
Harrisburg Family Medical Center Harrisburg Arkansas 72432 —
Accelovance. Inc San Diego California 92108 —
Benchmark Research San Francisco California 94102 —
Cassidy Medical Group/Clinical Research Advantage Vista California 92083 —
Avail Clinical Research, LLC DeLand Florida 32720 —
Jacksonville Center for Clinical Research Jacksonville Florida 32216 —
Optimal Research, LLC Melbourne Florida 32934 —
Accelovance Melbourne Florida 32935 —
Miami Research Associates South Miami Florida 33143 —
Accelovance,Inc. Mishawaka Indiana 46545 —
Clinical Research Advantage,Inc/Ridge Family Practice Council Bluffs Iowa 51503 —
Kentucky Pediatric/Adult Research Bardstown Kentucky 40004 —
Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP Fremont Nebraska 68025 —
Prairie Fields Family Medicine/Clinical Research Advantage Fremont Nebraska 68025 —
Rochester Clinical Research, Inc. Rochester New York 14609 —
Rapid Medical Research. Inc. Cleveland Ohio 44122 —
Ohio Pediatric Research Association Dayton Ohio 45414 —
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464 —
PMG Research of Bristol Bristol Tennessee 37620 —
Benchmark Research Austin Texas 78705 —
Tekton Research Austin Texas 78745 —
Research Across America Dallas Texas 75234 —
Benchmark Research Fort Worth Texas 76135 —
West Houston Clinical Research Service Houston Texas 77055 —
Research Across America Katy Texas 77450 —
Clinical Trials of Texas, Inc. San Antonio Texas 78229 —
J. Lewis Research, Inc. - Foothill Family Clinic Salt Lake City Utah 84109 —
J. Lewis Research, Inc. / Foothill Family Clinic South Salt Lake City Utah 84121 —
Jean Brown Research Salt Lake City Utah 84124 —
J. Lewis Research, Inc. - Jordan River Family Medicine South Jordan Utah 84095 —
Advanced Clinical Research West Jordan Utah 84088 —
PI-Coor Clinical Research, LLC Burke Virginia 22015 —
Pediatric Research of Charlottesville Charlottesville Virginia 22902 —

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 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01352793, 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 Mar 11, 2015 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01352793 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →