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

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00562237

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Biological: S205 placebo Biological: S205 10ugHA Biological: S205 30ugHA Biological: S205 10ugHA+500ugAlOH Biological: S205 30ugHA+500ugAlOH Biological: S205 10ugHA+1250ugAlOH Biological: S205 30ugHA+1250ugAlOH	Phase I

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Hemagglutination inhibition titers [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CHMP criteria [ Time Frame: one year ] [ Designated as safety issue: No ]
Virus neutralization [ Time Frame: one year ] [ Designated as safety issue: No ]
Anti-HA antibody level kinetics [ Time Frame: one year ] [ Designated as safety issue: No ]
Safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	July 2007
Estimated Study Completion Date:	September 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Biological: S205 placebo 2 i.m. injections per subject (0.5 mL each)
2: Experimental	Biological: S205 10ugHA 2 i.m. injections per subject (0.5 mL each)
3: Experimental	Biological: S205 30ugHA 2 i.m. injections per subject (0.5 mL each)
4: Experimental	Biological: S205 10ugHA+500ugAlOH 2 i.m. injections per subject (0.5 mL each)
5: Experimental	Biological: S205 30ugHA+500ugAlOH 2 i.m. injections per subject (0.5 mL each)
6: Experimental	Biological: S205 10ugHA+1250ugAlOH 2 i.m. injections per subject (0.5 mL each)
7: Experimental	Biological: S205 30ugHA+1250ugAlOH 2 i.m. injections per subject (0.5 mL each)

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562237

Locations

Finland
Site 21
Helsinki, Finland
Site 22
Tampere, Finland
Site 23
Turku, Finland
Germany
Site 12
Goch, Germany
Site 11
Nürnberg, Germany
Site 10
Hamburg, Germany

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Joost Melis )
Study ID Numbers:	S205.1.001, 2007-000876-17
Study First Received:	November 20, 2007
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00562237
Health Authority:	Finland: National Agency for Medicines; Germany: Paul-Ehrlich-Institut

Keywords provided by Solvay Pharmaceuticals:

immunogenicity
safety
adjuvanted pandemic vaccine

Study placed in the following topic categories:

Influenza, Human
Healthy

ClinicalTrials.gov processed this record on January 14, 2009