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NCT02285777 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
189
Enrollment target

NCT02285777: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT02285777 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 189 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02285777, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
189 participants
Enrollment target

Study Summary

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.

Primary Outcome

The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects with

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Meningococcal ABCWY

Trial Details

FieldValue
Enrollment Target 189 participants
Start Date 2014-12-01
Est. Completion 2015-06-11
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT02285777 record still lists

NCT02285777 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02285777 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02285777 about?

NCT02285777 is a clinical study titled "Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents". 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 as...

What is the current status of trial NCT02285777?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2014-12-01. Estimated completion is 2015-06-11.

What interventions are being tested in trial NCT02285777?

The interventions under investigation include: Placebo (BIOLOGICAL), Meningococcal ABCWY (BIOLOGICAL).

Who is sponsoring clinical trial NCT02285777?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02285777's enrollment target sits among peer trials

189 355th of 2000 higher than 1,645 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02285777, the US trial registry maintained by the National Library of Medicine. NCT02285777 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.