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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 422 participants.

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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

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01659086

The ClinicalTrials.gov registry entry for NCT01659086 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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

NCT01659086 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.