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NCT00980005 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
2,116
Enrollment target

NCT00980005: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT00980005 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,116 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (174% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00980005, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
2,116 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Primary Outcome

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

Interventions

  • BIOLOGICAL Fluzone®
  • BIOLOGICAL GSK investigational vaccine GSK1557482A

Trial Details

FieldValue
Enrollment Target 2,116 participants
Start Date 2009-10-13
Est. Completion 2010-06-17
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT00980005 record still lists

NCT00980005 is an interventional study that assigns participants to a tested intervention. Its 2,116 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (174% higher).

The record links to 0 conditions, and to 2 interventions - of which Fluzone® is the first listed.

NCT00980005 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00980005 about?

NCT00980005 is a clinical study titled "Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children". The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

What is the current status of trial NCT00980005?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,116 participants. The study started on 2009-10-13. Estimated completion is 2010-06-17.

What interventions are being tested in trial NCT00980005?

The interventions under investigation include: Fluzone® (BIOLOGICAL), GSK investigational vaccine GSK1557482A (BIOLOGICAL).

Who is sponsoring clinical trial NCT00980005?

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 NCT00980005's enrollment target sits among peer trials

2,116 98th of 2000 higher than 1,903 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00980005, the US trial registry maintained by the National Library of Medicine. NCT00980005 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.