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)
Public ClinicalTrials.gov record NCT01992536. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01992536
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 194 participants
Conditions and interventions
Conditions
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 30, 2013
- Primary completion
- Apr 30, 2014
- Completion
- Mar 31, 2015
- Last update posted
- Oct 24, 2016
2013 – 2015
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 | Birmingham | Alabama | 35205 | — |
| Site 24, Madera Family Medical Group 1111 West 4th Street | Madera | California | 93637 | — |
| Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301 | Paramount | California | 90723 | — |
| Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street | Bardstown | Kentucky | 40004 | — |
| Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2 | Louisville | Kentucky | 40291 | — |
| Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200 | Dayton | Ohio | 45414 | — |
| Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive | Kettering | Ohio | 45420 | — |
| Site 22, Focus Research Group 201 Signature Place | Lebanon | Tennessee | 37087 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01992536, 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 Oct 24, 2016 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01992536 live on ClinicalTrials.gov.