We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00562237
Recruitment Status : Terminated (This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates)
First Posted : November 21, 2007
Last Update Posted : October 27, 2008
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : July 2007
Primary Completion Date : November 2007
Estimated Study Completion Date : September 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 [ Time Frame: one year ]

Secondary Outcome Measures :
  1. CHMP criteria [ Time Frame: one year ]
  2. Virus neutralization [ Time Frame: one year ]
  3. Anti-HA antibody level kinetics [ Time Frame: one year ]
  4. Safety [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Joost Melis, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00562237     History of Changes
Other Study ID Numbers: S205.1.001
2007-000876-17
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: October 27, 2008
Last Verified: October 2008

Keywords provided by Solvay Pharmaceuticals:
immunogenicity
safety
adjuvanted pandemic vaccine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs