CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 138 enrolled
Drug / intervention
Pandemic Influenza Vaccine (GSK1562902A) +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/NCT00502593
NCT00502593Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Open, Controlled Study to Evaluate the Safety and Immunogenicity of Different Formulations of a Pandemic Influenza Vaccine Candidate (Split Virus Formulation Adjuvanted With AS03) Given Following a Two-administration Schedule (21 Days Apart) in Children Between 3 and 9 Years of Age.

GlaxoSmithKline·interventional·Posted Jul 17, 2007·Updated Oct 25, 2018

In Brief

A Phase 2 clinical trial evaluating Pandemic Influenza Vaccine (GSK1562902A) and Fluarix™ for Influenza. Completed, enrolled 138 participants across 7 sites.

Detailed Summary

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2007
Enrollment StartJul 23, 2007
Primary CompletionDec 4, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.0 years ago

Interventions

Pandemic Influenza Vaccine (GSK1562902A)biological

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix™biological

2 doses, intramuscular injection on Days 0 and 21.