Healthy SubjectsPhase 1NCT00562237
Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine
A Phase 1 study testing S205 10ugHA, S205 30ugHA and S205 10ugHA+500ugAlOH in people with Healthy Subjects, run by Solvay Pharmaceuticals at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- S205 10ugHA, S205 30ugHA and S205 10ugHA+500ugAlOH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2007to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being healthy and ≥ 18 and ≤ 49 years of age
- willing and able to give informed consent
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
About this study
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.
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.
- Conditions
- Healthy Subjects
- Being tested
- S205 placebo, S205 10ugHA, S205 30ugHA, S205 10ugHA+500ugAlOH, S205 30ugHA+500ugAlOH
- Keywords
- immunogenicity, safety, adjuvanted pandemic vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S205 placeboBiological
2 i.m. injections per subject (0.5 mL each)
S205 10ugHABiological
2 i.m. injections per subject (0.5 mL each)
S205 30ugHABiological
2 i.m. injections per subject (0.5 mL each)
S205 10ugHA+500ugAlOHBiological
2 i.m. injections per subject (0.5 mL each)
S205 30ugHA+500ugAlOHBiological
2 i.m. injections per subject (0.5 mL each)
S205 10ugHA+1250ugAlOHBiological
2 i.m. injections per subject (0.5 mL each)
S205 30ugHA+1250ugAlOHBiological
2 i.m. injections per subject (0.5 mL each)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Biological: S205 placebo |
| 2 | Experimental | Not described Receives: Biological: S205 10ugHA |
| 3 | Experimental | Not described Receives: Biological: S205 30ugHA |
| 4 | Experimental | Not described Receives: Biological: S205 10ugHA+500ugAlOH |
| 5 | Experimental | Not described Receives: Biological: S205 30ugHA+500ugAlOH |
| 6 | Experimental | Not described Receives: Biological: S205 10ugHA+1250ugAlOH |
| 7 | Experimental | Not described Receives: Biological: S205 30ugHA+1250ugAlOH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination inhibition titers
Measured: one year
Secondary outcomes (4)
CHMP criteria
Measured: one year
Virus neutralization
Measured: one year
Anti-HA antibody level kinetics
Measured: one year
Safety
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2007
- Study completionSep 2008 (estimated)
Why it stopped: This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562237
- Sponsor's protocol ID
- S205.1.001
- Other IDs
- 2007-000876-17
- Status last verified
- Oct 2008
- First submitted
- 20 Nov 2007
- Last updated
- 27 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00562237
- Acronym / sponsor ID
- S205.1.001
- Conditions
- Healthy Subjects
- Keywords
- immunogenicity, safety, adjuvanted pandemic vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2008 (estimated)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: S205 placebo |
| 2 | Experimental | Biological: S205 10ugHA |
| 3 | Experimental | Biological: S205 30ugHA |
| 4 | Experimental | Biological: S205 10ugHA+500ugAlOH |
| 5 | Experimental | Biological: S205 30ugHA+500ugAlOH |
| 6 | Experimental | Biological: S205 10ugHA+1250ugAlOH |
| 7 | Experimental | Biological: S205 30ugHA+1250ugAlOH |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- being healthy and ≥ 18 and ≤ 49 years of age
- willing and able to give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S205 placebo2 i.m. injections per subject (0.5 mL each) | Biological | 1 |
| S205 10ugHA2 i.m. injections per subject (0.5 mL each) | Biological | 2 |
| S205 30ugHA2 i.m. injections per subject (0.5 mL each) | Biological | 3 |
| S205 10ugHA+500ugAlOH2 i.m. injections per subject (0.5 mL each) | Biological | 4 |
| S205 30ugHA+500ugAlOH2 i.m. injections per subject (0.5 mL each) | Biological | 5 |
| S205 10ugHA+1250ugAlOH2 i.m. injections per subject (0.5 mL each) | Biological | 6 |
| S205 30ugHA+1250ugAlOH2 i.m. injections per subject (0.5 mL each) | Biological | 7 |
Primary outcome
Hemagglutination inhibition titers
Time frame: one year
4 secondary outcomes
CHMP criteria
Time frame: one year
Virus neutralization
Time frame: one year
Anti-HA antibody level kinetics
Time frame: one year
Safety
Time frame: one year
Results and safety
The study was stopped early (reason given: This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S205 10ugHA, S205 30ugHA and S205 10ugHA+500ugAlOH in people with Healthy Subjects, run by Solvay Pharmaceuticals at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemagglutination inhibition titers (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2008.