Status:

COMPLETED

Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Lead Sponsor:

GlaxoSmithKline

Conditions:

Meningococcal Disease

Eligibility:

All Genders

10-19 years

Phase:

PHASE2

Brief Summary

This is extension of the V102\_16 study (NCT02140762). V102\_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, ...

Eligibility Criteria

Inclusion

  • Adolescents who completed V102\_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).

Exclusion

  • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
  • History of any meningococcal vaccine administration other than vaccination given in the parent V102\_16 protocol.

Key Trial Info

Start Date :

December 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 11 2015

Estimated Enrollment :

189 Patients enrolled

Trial Details

Trial ID

NCT02285777

Start Date

December 1 2014

End Date

June 11 2015

Last Update

September 24 2018

Active Locations (8)

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Page 1 of 2 (8 locations)

1

GSK Investigational Site

Huntsville, Alabama, United States, 35802

2

GSK Investigational Site

Jonesboro, Arkansas, United States, 72401

3

GSK Investigational Site

Melbourne, Florida, United States, 32934

4

GSK Investigational Site

Newton, Kansas, United States, 67114