Study Stopped
This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates
Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine
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.
2 other identifiers
interventional
400
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedOctober 27, 2008
October 1, 2008
4 months
November 20, 2007
October 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemagglutination inhibition titers
one year
Secondary Outcomes (4)
CHMP criteria
one year
Virus neutralization
one year
Anti-HA antibody level kinetics
one year
Safety
one year
Study Arms (7)
1
PLACEBO COMPARATOR2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTAL7
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- being healthy and ≥ 18 and ≤ 49 years of age
- willing and able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Site 21
Helsinki, Finland
Site 22
Tampere, Finland
Site 23
Turku, Finland
Site 12
Goch, Germany
Site 10
Hamburg, Germany
Site 11
Nuremberg, Germany
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 21, 2007
Study Start
July 1, 2007
Primary Completion
November 1, 2007
Study Completion
September 1, 2008
Last Updated
October 27, 2008
Record last verified: 2008-10