At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 437 enrolled

Drug / intervention

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00397215

NCT00397215Phase 2Completed

Compare CT.gov

Evaluate Immunogenicity & Safety of a Single or Double-dose of the Pandemic Influenza Candidate Vaccine (GSK1562902A) Given Following a Two-administration Schedule (21 Days Apart) in Adults Over 60 Yrs

GlaxoSmithKline·interventional·Posted Nov 8, 2006·Updated Jun 10, 2019

In Brief

A Phase 2 clinical trial evaluating Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) and Fluarix for Influenza. Completed, enrolled 437 participants across 12 sites in 2 countries.

Detailed Summary

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza

CountriesBelgium, Italy

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedNov 2006

Enrollment StartNov 2006

Primary CompletionSep 2009

TodayJul 2026

First PostedNov 8, 2006

Enrollment StartNov 17, 2006

Primary CompletionSep 14, 2009

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 19.7 years ago

Interventions

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)biological

intramuscular injection

Fluarixbiological

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.