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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: Meningococcal ABCWY; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02285777

205232

V102_16E1 (Other Identifier)

Details and patient eligibility

About

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, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be invited at the time of their last study visit to participate in this extension study.

Enrollment: 189 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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189 participants in 2 patient groups

MenABCWY Group

Experimental group

Description:

Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.

Treatment:

Biological: Meningococcal ABCWY

MenACWY Group

Active Comparator group

Description:

Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.

Treatment:

Biological: Placebo