Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00529516 · ClinicalTrials.gov registry record · Phase 3
Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,252
- Enrollment target
NCT00529516: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00529516 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,252 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00529516, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,252 participants
- Enrollment target
Study Summary
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
Primary Outcome
Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Interventions
- BIOLOGICAL Fluarix
- BIOLOGICAL GSK Biologicals Influenza Vaccine GSK576389A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,252 participants |
| Start Date | 2007-10-15 |
| Est. Completion | 2008-06-04 |
| Phase | Phase 3 |
What the finished NCT00529516 record still lists
NCT00529516 is an interventional study that assigns participants to a tested intervention. Its 1,252 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 (62% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluarix is the first listed.
NCT00529516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00529516 about?
NCT00529516 is a clinical study titled "Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults". Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the sub...
What is the current status of trial NCT00529516?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,252 participants. The study started on 2007-10-15. Estimated completion is 2008-06-04.
What interventions are being tested in trial NCT00529516?
The interventions under investigation include: Fluarix (BIOLOGICAL), GSK Biologicals Influenza Vaccine GSK576389A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00529516?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00529516's enrollment target sits among peer trials
1,252 206th of 2000 higher than 1,795 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02743858 · 1,250 participants
Lymphedema Surveillance Study
- NCT04670874 · 1,250 participants
Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29
- NCT04807868 · 1,250 participants
AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)
- NCT05995821 · 1,250 participants
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI