NCT01992536

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MenABCWY+OMV	Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
BIOLOGICAL	MenABCWY+¼OMV	Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
BIOLOGICAL	Placebo	Saline solution for injection (0.5mL)

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• Completion: 2015-04-01
• First posted: 2013-11-25
• Last updated: 2016-10-25
• Results posted: 2016-10-25

Locations

13 sites across 2 countries: United States, Poland