InfluenzaPhase 1NCT00814229
Safety and Immunogenicity of Influenza H9 Vaccine in Humans
A Phase 1 study testing H9N2 whole virus vaccine, IM, 1.5microg, H9N2 whole virus vaccine, IM, 5microg and H9N2 whole virus vaccine vaccine, IM, 15microg in people with Influenza, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in children. Influenza H9N2 poses a pandemic threat to humans. This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole virus and virosomal H9N2 vaccines by the intramuscular route. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- H9N2 whole virus vaccine, IM, 1.5microg, H9N2 whole virus vaccine, IM, 5microg and H9N2 whole virus vaccine vaccine, IM, 15microg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
- Male or female subjects over 18 years who are either healthy or have a stable medical condition.
- Able to understand and comply with all study procedures and to complete study diaries
- Individuals who can be contacted throughout the study and are available for all study visits
- Females should either be using secure contraceptive precautions including a) the oral contraceptive pill, b) condom/barrier contraception c) partner has had a vasectomy, d) be surgically sterilised, or e) post- (defined as at least two years since the last menstrual period)
Who cannot join
- Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
- Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to eggs, chicken protein, chicken feathers, influenzal viral protein, neomycin or polymixin, or products containing mercury.
- Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
- Subjects who are at high risk of developing illnesses of the immune system.
- Individuals who are taking immunostimulant therapy or interferon
- Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
Show all 16Show fewer
- Women should not be pregnant or lactating.
- Women who refuse to use a reliable contraceptive method throughout the study
- Known or suspected drug abuse.
- Individuals who have received another vaccine or experimental (investigational) drug in the preceding 4 weeks.
- Individuals who have previously received H9N2 vaccine
- Unable to lead an independent life either physically or mentally
- Regularly drink more than 40 units of alcohol weekly
- Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable).
- Individuals who had a temperature over 38 degrees C in the preceding 3 days.
- Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Leicester
Leicester, Leicestershire, LE1 5WW
About this study
Official title: Randomised Dose Ranging Observer Blind Single Centre Study to Evaluate Safety and Immunogenicity of Adjuvanted and Non-adjuvanted Influenza H9 Influenza Vaccine in Humans
H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in children. Influenza H9N2 poses a pandemic threat to humans.
This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal route of administration to see if this has any advantages. The aim is to assess antibody responses before and after vaccination. The hypothesis is that lower doses of adjuvanted vaccine will induce similar antibody responses to non-adjuvanted vaccine
Read the detailed description
A double-blind, single centre comparative study in which fourteen groups of 40 male and female adults >18 years of age will be randomly allocated to receive 1.7, 5, 15 or 45 µg quantities of whole virion (WV), Aluminium -adjuvanted WV(Al-WV), and virosomal (V) influenza A/Hong Kong/1073/99 (H9N2) vaccines by intramuscular injection into the deltoid muscle; or 5 or 15microg WV vaccine administered by intradermal injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation (day 0 and 21), and will be monitored for any reactions and other adverse events for 7 days after immunisation. Blood for immunogenicity studies will be obtained at day 0 (pre-immunisation), day-21 (+4 days), and at day-42 (i.e., 21 +4 days after the second immunization). Immunogenicity will be evaluated by haemagglutination inhibition, virus neutralization,, single radial haemolysis, neuraminidase inhibition and cellular mediated responses (in a subset of 5-10 subjects from each group).
- Conditions
- Influenza
- Being tested
- H9N2 whole virus vaccine, IM, 1.5microg, H9N2 whole virus vaccine, IM, 5microg, H9N2 whole virus vaccine vaccine, IM, 15microg, H9N2 whole virus vaccine, IM, 45microg, H9N2 whole virus vaccine, alum, IM, 1.5microg
- Keywords
- influenza, H9N2, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H9N2 whole virus vaccine, IM, 1.5microgBiological
influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection
H9N2 whole virus vaccine, IM, 5microgBiological
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection
H9N2 whole virus vaccine vaccine, IM, 15microgBiological
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection
H9N2 whole virus vaccine, IM, 45microgBiological
influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection
H9N2 whole virus vaccine, alum, IM, 1.5microgBiological
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection
H9N2 whole virus, alum, IM, 5microgBiological
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection
H9N2 vaccine, whole virus, alum, IM, 15 microgBiological
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection
H9N2 vaccine, whole virus, alum, IM, 45microgBiological
influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection
H9N2 virosome vaccine, IM, 1.5microgBiological
influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection
H9N2 virosomal vaccine, IM, 5microgBiological
influenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection
H9N2 virosomal vaccine, IM, 15microgBiological
influenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection
H9N2 virosomal vaccine, IM, 45microgBiological
influenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection
H9N2 whole virus vaccine, ID, 5microgBiological
influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection
H9N2 whole virus vaccine, ID, 15microgBiological
influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Vaccine 1 | Active comparator | influenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 whole virus vaccine, IM, 1.5microg |
| vaccine 2 | Active comparator | influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 whole virus vaccine, IM, 5microg |
| Vaccine 3 | Active comparator | influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 whole virus vaccine vaccine, IM, 15microg |
| Vaccine 4 | Active comparator | influenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 whole virus vaccine, IM, 45microg |
| Vaccine 5 | Active comparator | influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 whole virus vaccine, alum, IM, 1.5microg |
| Vaccine 6 | Active comparator | influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 whole virus, alum, IM, 5microg |
| Vaccine 7 | Active comparator | influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 vaccine, whole virus, alum, IM, 15 microg |
| Vaccine 8 | Active comparator | influenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 vaccine, whole virus, alum, IM, 45microg |
| Vaccine 9 | Active comparator | influenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 virosome vaccine, IM, 1.5microg |
| Vaccine 10 | Active comparator | influenza H9N2 vaccine virosomal containing 5microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 virosomal vaccine, IM, 5microg |
| Vaccine 11 | Active comparator | influenza H9N2 vaccine virosomal containing 15microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 virosomal vaccine, IM, 15microg |
| Vaccine 12 | Active comparator | influenza H9N2 vaccine virosomal containing 45microg haemagglutinin by intramuscular injection Receives: Biological: H9N2 virosomal vaccine, IM, 45microg |
| Vaccine 13 | Active comparator | influenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection Receives: Biological: H9N2 whole virus vaccine, ID, 5microg |
| Vaccine 14 | Active comparator | influenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection Receives: Biological: H9N2 whole virus vaccine, ID, 15microg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays
Measured: Pre vaccination, 21 days and 42 days
Secondary outcomes (2)
Local and systemic reactogenicity of influenza H9 vaccine
Measured: within 7 days of vaccination
seroprotective antibody titres to influenza H9 by HI and neutralising antibody
Measured: pre vacciantion, 21 and 42 days post-vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Crucell Holland BV, National Institute of Biological Standards and Control, Public Health England
- Investigators
- Karl G Nicholson, FRCP, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814229
- Sponsor's protocol ID
- UHL 08162
- Other IDs
- REC 6794
- Status last verified
- Jul 2009
- First submitted
- 23 Dec 2008
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Dose Ranging Observer Blind Single Centre Study to Evaluate Safety and Immunogenicity of Adjuvanted and Non-adjuvanted Influenza H9 Influenza Vaccine in Humans
- ClinicalTrials.gov ID
- NCT00814229
- Acronym / sponsor ID
- UHL 08162
- Conditions
- Influenza
- Keywords
- influenza, H9N2, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Crucell Holland BV, National Institute of Biological Standards and Control, Public Health England
- Study start
- Aug 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Dec 2008 (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.
H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in children. Influenza H9N2 poses a pandemic threat to humans.
This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal route of administration to see if this has any advantages. The aim is to assess antibody responses before and after vaccination. The hypothesis is that lower doses of adjuvanted vaccine will induce similar antibody responses to non-adjuvanted vaccine
Detailed description
A double-blind, single centre comparative study in which fourteen groups of 40 male and female adults >18 years of age will be randomly allocated to receive 1.7, 5, 15 or 45 µg quantities of whole virion (WV), Aluminium -adjuvanted WV(Al-WV), and virosomal (V) influenza A/Hong Kong/1073/99 (H9N2) vaccines by intramuscular injection into the deltoid muscle; or 5 or 15microg WV vaccine administered by intradermal injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation (day 0 and 21), and will be monitored for any reactions and other adverse events for 7 days after immunisation. Blood for immunogenicity studies will be obtained at day 0 (pre-immunisation), day-21 (+4 days), and at day-42 (i.e., 21 +4 days after the second immunization). Immunogenicity will be evaluated by haemagglutination inhibition, virus neutralization,, single radial haemolysis, neuraminidase inhibition and cellular mediated responses (in a subset of 5-10 subjects from each group).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Vaccine 1 | Active comparator | Biological: H9N2 whole virus vaccine, IM, 1.5microginfluenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection |
| vaccine 2 | Active comparator | Biological: H9N2 whole virus vaccine, IM, 5microginfluenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection |
| Vaccine 3 | Active comparator | Biological: H9N2 whole virus vaccine vaccine, IM, 15microginfluenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection |
| Vaccine 4 | Active comparator | Biological: H9N2 whole virus vaccine, IM, 45microginfluenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection |
| Vaccine 5 | Active comparator | Biological: H9N2 whole virus vaccine, alum, IM, 1.5microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection |
| Vaccine 6 | Active comparator | Biological: H9N2 whole virus, alum, IM, 5microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection |
| Vaccine 7 | Active comparator | Biological: H9N2 vaccine, whole virus, alum, IM, 15 microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection |
| Vaccine 8 | Active comparator | Biological: H9N2 vaccine, whole virus, alum, IM, 45microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection |
| Vaccine 9 | Active comparator | Biological: H9N2 virosome vaccine, IM, 1.5microginfluenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection |
| Vaccine 10 | Active comparator | Biological: H9N2 virosomal vaccine, IM, 5microginfluenza H9N2 vaccine virosomal containing 5microg haemagglutinin by intramuscular injection |
| Vaccine 11 | Active comparator | Biological: H9N2 virosomal vaccine, IM, 15microginfluenza H9N2 vaccine virosomal containing 15microg haemagglutinin by intramuscular injection |
| Vaccine 12 | Active comparator | Biological: H9N2 virosomal vaccine, IM, 45microginfluenza H9N2 vaccine virosomal containing 45microg haemagglutinin by intramuscular injection |
| Vaccine 13 | Active comparator | Biological: H9N2 whole virus vaccine, ID, 5microginfluenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection |
| Vaccine 14 | Active comparator | Biological: H9N2 whole virus vaccine, ID, 15microginfluenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
- Male or female subjects over 18 years who are either healthy or have a stable medical condition.
- Able to understand and comply with all study procedures and to complete study diaries
- Individuals who can be contacted throughout the study and are available for all study visits
- Females should either be using secure contraceptive precautions including a) the oral contraceptive pill, b) condom/barrier contraception c) partner has had a vasectomy, d) be surgically sterilised, or e) post- (defined as at least two years since the last menstrual period)
Key exclusion criteria (16 listed)
- Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
- Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to eggs, chicken protein, chicken feathers, influenzal viral protein, neomycin or polymixin, or products containing mercury.
- Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
- Subjects who are at high risk of developing illnesses of the immune system.
- Individuals who are taking immunostimulant therapy or interferon
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 |
|---|---|---|
| H9N2 whole virus vaccine, IM, 1.5microginfluenza H9N2 vaccine whole virus containing 1.5microg haemagglutinin by intramuscular injection | Biological | Vaccine 1 |
| H9N2 whole virus vaccine, IM, 5microginfluenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intramuscular injection | Biological | vaccine 2 |
| H9N2 whole virus vaccine vaccine, IM, 15microginfluenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intramuscular injection | Biological | Vaccine 3 |
| H9N2 whole virus vaccine, IM, 45microginfluenza H9N2 vaccine whole virus containing 45microg haemagglutinin by intramuscular injection | Biological | Vaccine 4 |
| H9N2 whole virus vaccine, alum, IM, 1.5microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 1.5microg haemagglutinin by intramuscular injection | Biological | Vaccine 5 |
| H9N2 whole virus, alum, IM, 5microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 5microg haemagglutinin by intramuscular injection | Biological | Vaccine 6 |
| H9N2 vaccine, whole virus, alum, IM, 15 microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 15microg haemagglutinin by intramuscular injection | Biological | Vaccine 7 |
| H9N2 vaccine, whole virus, alum, IM, 45microginfluenza H9N2 vaccine whole virus adjuvanted with alum hydroxide containing 45microg haemagglutinin by intramuscular injection | Biological | Vaccine 8 |
| H9N2 virosome vaccine, IM, 1.5microginfluenza H9N2 vaccine virosomal containing 1.5microg haemagglutinin by intramuscular injection | Biological | Vaccine 9 |
| H9N2 virosomal vaccine, IM, 5microginfluenza H9N2 vaccine virosome containing 5microg haemagglutinin by intramuscular injection | Biological | Vaccine 10 |
| H9N2 virosomal vaccine, IM, 15microginfluenza H9N2 vaccine virosome containing 15microg haemagglutinin by intramuscular injection | Biological | Vaccine 11 |
| H9N2 virosomal vaccine, IM, 45microginfluenza H9N2 vaccine virosome containing 45microg haemagglutinin by intramuscular injection | Biological | Vaccine 12 |
| H9N2 whole virus vaccine, ID, 5microginfluenza H9N2 vaccine whole virus containing 5microg haemagglutinin by intradermal injection | Biological | Vaccine 13 |
| H9N2 whole virus vaccine, ID, 15microginfluenza H9N2 vaccine whole virus containing 15microg haemagglutinin by intradermal injection | Biological | Vaccine 14 |
Primary outcome
Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays
Time frame: Pre vaccination, 21 days and 42 days
2 secondary outcomes
Local and systemic reactogenicity of influenza H9 vaccine
Time frame: within 7 days of vaccination
seroprotective antibody titres to influenza H9 by HI and neutralising antibody
Time frame: pre vacciantion, 21 and 42 days post-vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
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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.
Karl G Nicholson, FRCP, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H9N2 whole virus vaccine, IM, 1.5microg, H9N2 whole virus vaccine, IM, 5microg and H9N2 whole virus vaccine vaccine, IM, 15microg in people with Influenza, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Geometric mean antibody titres of antibody to influenza H9 by HI and neutralising antibody assays (time frame: Pre vaccination, 21 days and 42 days). 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 21 Jul 2009.