Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00616928 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
A Phase 3 study of Influenza, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,561
- Enrollment target
- 20
- Study locations
NCT00616928: Completed Phase 3 study of Influenza, sponsored by GlaxoSmithKline.
NCT00616928 is a Phase 3 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,561 participants, below the 36,775-participant average among 156 other Influenza trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616928, a Phase 3 study of Influenza, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,561 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
Primary Outcome
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Study Locations (20)
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Melbourne
- GSK Investigational Site - Miami
- GSK Investigational Site - Pembroke Pines
Illinois
- GSK Investigational Site - Chicago
- GSK Investigational Site - Peoria
Kansas
- GSK Investigational Site - Lenexa
- GSK Investigational Site - Wichita
Alabama
- GSK Investigational Site - Huntsville
Arizona
- GSK Investigational Site - Phoenix
California
- GSK Investigational Site - Anaheim
Georgia
- GSK Investigational Site - Stockbridge
Indiana
- GSK Investigational Site - South Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,561 participants |
| Start Date | 2008-01-23 |
| Est. Completion | 2009-03-19 |
| Phase | Phase 3 |
What the finished NCT00616928 record still lists
NCT00616928 is an interventional study that assigns participants to a tested intervention. Its 4,561 participants enrollment target places it among the larger protocols in the corpus, below the 36,775-participant average among 156 other Influenza trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00616928 names 20 study sites across 15 states, led by Florida, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT00616928 about?
NCT00616928 is a clinical study titled "Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years". The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
What is the current status of trial NCT00616928?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,561 participants. The study started on 2008-01-23. Estimated completion is 2009-03-19.
What conditions does trial NCT00616928 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00616928?
The interventions under investigation include: Placebo (BIOLOGICAL), Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (BIOLOGICAL).
Who is sponsoring clinical trial NCT00616928?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00616928 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00616928's enrollment target sits among peer trials
4,561 18th of 156 higher than 139 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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
-
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
COMPLETED · Phase 3
-
Study of Quadrivalent Influenza Vaccine Among Children
COMPLETED · Phase 3
-
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
COMPLETED · Phase 3
-
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
COMPLETED · Phase 3
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
- NCT05768217 · 4,600 participants · NA
Community Resiliency Collective Efficacy Intervention
- NCT06702878 · 4,514 participants · Phase 3
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
- NCT06533111 · 4,500 participants · NA
Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
- NCT06588452 · 4,500 participants
Manual Versus AI-Assisted Clinical Trial Screening Using Large-Language Models
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