NCT00430521

Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

Reactogenicity and Immunogenicity Study of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1119711A) Administered According to Different Vaccination Schedules

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess the safety \& immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Influenza
• Influenza Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Pandemic influenza vaccine (GSK1119711A)-formulation 1	2 or 3 doses, intramuscular injection, at different time points.
BIOLOGICAL	Pandemic influenza vaccine (GSK1119711A)-formulation 2	2 or 3 doses, intramuscular injection, at different time points.

Timeline

• Start date: 2007-02-05
• Primary completion: 2008-10-20
• Completion: 2008-10-20
• First posted: 2007-02-02
• Last updated: 2019-10-28
• Results posted: 2019-10-28

Locations

10 sites across 1 country: Germany