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COMPLETED Phase 2

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

NCT00985673 · View on ClinicalTrials.gov ↗

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

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00985673

The ClinicalTrials.gov registry entry for NCT00985673 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 611 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00985673 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Texas, Quebec, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00985673?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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