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

NCT ID: NCT02285777

Last Updated: 2018-09-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2015-06-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MenABCWY Group

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

Group Type EXPERIMENTAL

Meningococcal ABCWY

Intervention Type BIOLOGICAL

One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

MenACWY Group

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.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

Interventions

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Meningococcal ABCWY

One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

Intervention Type BIOLOGICAL

Placebo

One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntsville, Alabama, United States

Site Status

GSK Investigational Site

Jonesboro, Arkansas, United States

Site Status

GSK Investigational Site

Melbourne, Florida, United States

Site Status

GSK Investigational Site

Newton, Kansas, United States

Site Status

GSK Investigational Site

Wichita, Kansas, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.

Reference Type DERIVED
PMID: 35257644 (View on PubMed)

Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.

Reference Type DERIVED
PMID: 30061029 (View on PubMed)

Other Identifiers

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V102_16E1

Identifier Type: OTHER

Identifier Source: secondary_id

205232

Identifier Type: -

Identifier Source: org_study_id

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