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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00562237
First received: November 20, 2007
Last updated: October 24, 2008
Last verified: October 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014