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NCT01659086 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
422
Enrollment target

NCT01659086: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT01659086 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 422 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (603% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01659086, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
422 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Investigational H9N2 vaccine GSK2654911A
  • BIOLOGICAL Investigational H9N2 vaccine GSK2654909A

Trial Details

FieldValue
Enrollment Target 422 participants
Start Date 2012-08-22
Est. Completion 2014-03-19
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT01659086 record still lists

NCT01659086 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (603% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01659086 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01659086 about?

NCT01659086 is a clinical study titled "Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age". The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.

What is the current status of trial NCT01659086?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 422 participants. The study started on 2012-08-22. Estimated completion is 2014-03-19.

What interventions are being tested in trial NCT01659086?

The interventions under investigation include: Placebo (BIOLOGICAL), Investigational H9N2 vaccine GSK2654911A (BIOLOGICAL), Investigational H9N2 vaccine GSK2654909A (BIOLOGICAL).

Who is sponsoring clinical trial NCT01659086?

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 NCT01659086's enrollment target sits among peer trials

422 65th of 2000 higher than 1,936 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01659086, the US trial registry maintained by the National Library of Medicine. NCT01659086 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.