NCT02451514

A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

A Phase 2, Open-label, Controlled, Multi-center Extension Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Years – 23 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY

Detailed description

Subjects will be randomised into two different blood draw schedules according to a 1:1 ratio

Conditions

• Meningococcal Disease
• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	MenABCWY+OMV vaccine	Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.

Timeline

• Start date: 2015-06-30
• Primary completion: 2015-11-14
• Completion: 2015-12-10
• First posted: 2015-05-22
• Last updated: 2020-07-09
• Results posted: 2020-07-09

Locations

7 sites across 3 countries: Chile, Colombia, Panama

Regulatory

• FDA-regulated drug study