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

• Sponsor: Solvay Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00562237
• Collaborator: (none)
• Enrollment: 400
• Locations: 6
• Arms: 7
• Duration (Months): 14.1
• Patients Per Site: 66.7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	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 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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.
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Anticipated Study Completion Date: Sep 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hemagglutination inhibition titers [one year]

Secondary Outcome Measures

1. CHMP criteria [one year]

2. Virus neutralization [one year]

3. Anti-HA antibody level kinetics [one year]

4. Safety [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Site 21	Helsinki		Finland
2	Site 22	Tampere		Finland
3	Site 23	Turku		Finland
4	Site 12	Goch		Germany
5	Site 10	Hamburg		Germany
6	Site 11	Nürnberg		Germany

Sponsors and Collaborators

• Solvay Pharmaceuticals

Investigators

• Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00562237
• Other Study ID Numbers: S205.1.001; 2007-000876-17
• First Posted: Nov 21, 2007
• Last Update Posted: Oct 27, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: immunogenicity; safety; adjuvanted pandemic vaccine

Study Results

No Results Posted as of Oct 27, 2008