NCT00562237

Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine

Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Surface Antigen Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	S205 placebo	2 i.m. injections per subject (0.5 mL each)
BIOLOGICAL	S205 10ugHA	2 i.m. injections per subject (0.5 mL each)
BIOLOGICAL	S205 30ugHA	2 i.m. injections per subject (0.5 mL each)
BIOLOGICAL	S205 10ugHA+500ugAlOH	2 i.m. injections per subject (0.5 mL each)
BIOLOGICAL	S205 30ugHA+500ugAlOH	2 i.m. injections per subject (0.5 mL each)
BIOLOGICAL	S205 10ugHA+1250ugAlOH	2 i.m. injections per subject (0.5 mL each)
BIOLOGICAL	S205 30ugHA+1250ugAlOH	2 i.m. injections per subject (0.5 mL each)

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-11-01
• Completion: 2008-09-01
• First posted: 2007-11-21
• Last updated: 2008-10-27

Locations

6 sites across 2 countries: Finland, Germany