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NCT00562237 Clinical Trial

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

Healthy Subjects Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00562237
Other study ID # S205.1.001
Secondary ID 2007-000876-17
Status Terminated
Phase Phase 1
First received November 20, 2007
Last updated October 24, 2008
Start date July 2007
Est. completion date September 2008

Study information
Verified date October 2008
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines AgencyGermany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 400
Est. completion date September 2008
Est. primary completion date November 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- being healthy and = 18 and = 49 years of age

- willing and able to give informed consent

Exclusion Criteria:

- having participated in an influenza H5 vaccine trial in the past

- known to be allergic to any constituent of the vaccine

- serious adverse reactions to previous (influenza) vaccination

- currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study

- using medication that influences the immune system

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• S205 placebo
2 i.m. injections per subject (0.5 mL each)
• S205 10ugHA
2 i.m. injections per subject (0.5 mL each)
• S205 30ugHA
2 i.m. injections per subject (0.5 mL each)
• S205 10ugHA+500ugAlOH
2 i.m. injections per subject (0.5 mL each)
• S205 30ugHA+500ugAlOH
2 i.m. injections per subject (0.5 mL each)
• S205 10ugHA+1250ugAlOH
2 i.m. injections per subject (0.5 mL each)
• S205 30ugHA+1250ugAlOH
2 i.m. injections per subject (0.5 mL each)

Locations
Country Name City State
Finland Site 21 Helsinki
Finland Site 22 Tampere
Finland Site 23 Turku
Germany Site 12 Goch
Germany Site 10 Hamburg
Germany Site 11 Nürnberg

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Finland,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemagglutination inhibition titers one year No
Secondary CHMP criteria one year No
Secondary Virus neutralization one year No
Secondary Anti-HA antibody level kinetics one year No
Secondary Safety one year Yes
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