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

PHASE2CompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

November 30, 2014

Study Completion Date

February 28, 2015

Conditions
Meningococcal Disease
Interventions
BIOLOGICAL

MenABCWY

Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.

OTHER

Placebo

0.5 mL saline solution (IM)

BIOLOGICAL

MenACWY

Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.

Trial Locations (8)

32935

Accelovance, Inc, Melbourne

35802

Accelovance, Inc, Huntsville

40291

Bluegrass Clinical Research, Inc., Louisville

44121

Senders Pediatrics, Cleveland

67114

Heartland Research Associates LLC, Newton

67207

Heartland Research Associates, LLC, Wichita

68134

Meridian Clinical Research, Omaha

72401

The Children's Clinic of Jonesboro, P.A., Jonesboro

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Novartis Vaccines

INDUSTRY