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

NCT00562237 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2008-10-27

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-11-30
Completion
2008-09-30

Countries

  • Finland
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562237 on ClinicalTrials.gov