Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine
This study has been terminated.
(This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates)
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00562237
First received: November 20, 2007
Last updated: October 24, 2008
Last verified: October 2008
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
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 |
|---|---|
| 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)
|
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 10 | |
| Hamburg, Germany | |
| Site 11 | |
| Nürnberg, Germany | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Joost Melis, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00562237 History of Changes |
| Other Study ID Numbers: | S205.1.001, 2007-000876-17 |
| Study First Received: | November 20, 2007 |
| Last Updated: | October 24, 2008 |
| Health Authority: | Finland: Finnish Medicines Agency Germany: Paul-Ehrlich-Institut |
Keywords provided by Solvay Pharmaceuticals:
|
immunogenicity safety adjuvanted pandemic vaccine |
ClinicalTrials.gov processed this record on June 18, 2013