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NCT00985673 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults

A Phase 2 study of Influenza, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
611
Enrollment target
7
Study locations

NCT00985673 is a Phase 2 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 611 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 5 states.

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The verdict

NCT00985673, a Phase 2 study of Influenza, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
611 participants
Enrollment target
7
Study locations

Study Summary

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.

Conditions Studied

Interventions

  • BIOLOGICAL GSK2340274A
  • BIOLOGICAL GSK2340273A
  • BIOLOGICAL Seasonal trivalent influenza vaccine (TIV)
  • BIOLOGICAL Saline placebo

Study Locations (7)

Texas

  • GSK Investigational Site - Austin
  • GSK Investigational Site - Fort Worth

Quebec

  • GSK Investigational Site - Montreal
  • GSK Investigational Site - Sherbrooke

Georgia

  • GSK Investigational Site - Stockbridge

North Carolina

  • GSK Investigational Site - Raleigh

Nova Scotia

  • GSK Investigational Site - Halifax

Trial Details

FieldValue
Enrollment Target 611 participants
Start Date 2009-10-01
Est. Completion 2010-12-29
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00985673

The ClinicalTrials.gov registry entry for NCT00985673 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 611 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 4 interventions - of which GSK2340274A is the first listed.

NCT00985673 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Texas, Quebec, Georgia.

Frequently Asked Questions

What is clinical trial NCT00985673 about?

NCT00985673 is a clinical study titled "Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults". The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.

What is the current status of trial NCT00985673?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 611 participants. The study started on 2009-10-01. Estimated completion is 2010-12-29.

What conditions does trial NCT00985673 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00985673?

The interventions under investigation include: GSK2340274A (BIOLOGICAL), GSK2340273A (BIOLOGICAL), Seasonal trivalent influenza vaccine (TIV) (BIOLOGICAL), Saline placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT00985673?

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

Where is trial NCT00985673 being conducted?

This trial has 7 study locations across Georgia, North Carolina, Texas, Nova Scotia, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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