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COMPLETED Phase 2

Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

NCT00985088 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.

Conditions Studied

Interventions

  • BIOLOGICAL GSK2340274A
  • BIOLOGICAL GSK2340273A
  • BIOLOGICAL Saline placebo

Study Locations (14)

Florida

  • GSK Investigational Site — Jacksonville
  • GSK Investigational Site — Miami

Alabama

  • GSK Investigational Site — Huntsville

Idaho

  • GSK Investigational Site — Meridian

Kansas

  • GSK Investigational Site — Lenexa

Montana

  • GSK Investigational Site — Missoula

Nevada

  • GSK Investigational Site — Las Vegas

New Jersey

  • GSK Investigational Site — Edison

New York

  • GSK Investigational Site — Rochester

Trial Details

FieldValue
Enrollment Target 1,343 participants
Start Date 2009-10-11
Est. Completion 2010-12-16
Phase Phase 2

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00985088

The ClinicalTrials.gov registry entry for NCT00985088 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 1,343 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 3 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: NCT00985088 reports 14 study locations spanning 13 distinct geographic areas — top geographies include Florida, Alabama, Idaho. 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 NCT00985088 about?

NCT00985088 is a clinical study titled "Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older". The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.

What is the current status of trial NCT00985088?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,343 participants. The study started on 2009-10-11. Estimated completion is 2010-12-16.

What conditions does trial NCT00985088 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 NCT00985088?

The interventions under investigation include: GSK2340274A (BIOLOGICAL), GSK2340273A (BIOLOGICAL), Saline placebo (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00985088?

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 NCT00985088 being conducted?

This trial has 14 study locations across Alabama, Florida, Idaho, Kansas, Montana. 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