NCT02140762

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

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-11-01
• Completion: 2015-02-01
• First posted: 2014-05-16
• Last updated: 2018-09-12
• Results posted: 2018-06-26

Locations

8 sites across 1 country: United States