InfluenzaPhase 1/2NCT00814385
Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04
A Phase 1/2 study testing Aflunov (Single prime, single boost), Aflunov (Double prime, single boost) and Aflunov (No prime, single boost) in people with Influenza, run by University Hospitals, Leicester at 2 sites in United Kingdom.
Trial summary
This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic. 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?
- Aflunov (Single prime, single boost), Aflunov (Double prime, single boost) and Aflunov (No prime, single boost)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2008to Dec 2013
- Phase
- Phase 1/2
- 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
- Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
- Are in good health or have one or more stable (See footnote) medical conditions, as determined by:
- Medical history,
- Physical examination,
- Clinical judgment of the medical investigator;
- Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
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- Subjects who experienced fever (defined as axillary temperature >38oC) within 3 days prior to Visit 1;
- Subjects who are pregnant or breastfeeding;
- Females of childbearing potential who refuse to use an acceptable method of birth control for a period of 56 days before and after each vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), monogamous relationship with vasectomised partner who has been vasectomised for 6 months or more prior to the subject's study entry, or abstain from heterosexual intercourse (e.g., through sexual orientation or religious or other beliefs about premarital intercourse);
- Subjects with any serious disease, including:
- cancer,
- acute or progressive hepatic disease,
- acute or progressive renal disease,
- chronic pulmonary disease requiring home oxygen therapy,
- active neurological disorder,
- autoimmune disease (including rheumatoid arthritis);
- Subjects for whom surgery is planned during the study period;
- Subjects with a bleeding diathesis;
- Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin, or any other component of the study vaccine;
- Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine;
- Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
- receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or cancer chemotherapy) (long-term, inhaled steroids for asthma management is acceptable),
- receipt of immunostimulants or interferon,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5 (Day 382), or planned during the full length of the study,
- high risk from developing an immunocompromising disease;
- Actual or planned receipt of another vaccine during the period 3 weeks before to 3 weeks after vaccination on Days 1, 22, and 382;
- Subjects with a history of (or current) drug or alcohol abuse (20g/day for females; 30g/day for males) that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
- Subjects who are unable to lead an independent life either physically or mentally;
- Have participated in a previous study of H5 avian influenza vaccine;
- Have been previously vaccinated with a vaccine containing MF59 or similar adjuvant;
- Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Leicester
Leicester, Leicestershire, LE1 5WW
Clincal Trials Unit Leicester Royal Infirmary
Leicester, LE1 5WW
About this study
Official title: A Randomized, Partially Observer-blind, Single-centre Study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Influenza Vaccines in Adults Primed With Adjuvanted Influenza A/Vietnam/1194/04 (H5N1) Vaccine
This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.
Read the detailed description
OBJECTIVES:
Immunogenicity objectives
- To evaluate the magnitude of the antibody responses to one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine, each dose containing 7.5μg of H5N1 haemagglutinin, in immunologically naïve subjects;
- To examine the kinetics of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75 or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
- To evaluate the magnitude of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75μg or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
- To evaluate the breadth of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above), with respect to a representative range of antigenically distinct H5N1 viruses (wild-type and attenuated); and
- To evaluate the persistence of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above).
Safety objective
- To evaluate the safety of the administration of one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (each dose containing 7.5μg of H5N1 haemagglutinin), in immunologically naïve subjects, followed by one 3.75μg or 7.5μg 'booster' dose of antigenically drifted MF59-adjuvanted H5N1 vaccine, or non-adjuvanted antigenically drifted H5N1 vaccine.
- Conditions
- Influenza
- Being tested
- Aflunov (Single prime, single boost), Aflunov (Double prime, single boost), Aflunov (No prime, single boost)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflunov (Single prime, single boost)Biological
Also called Aflunov
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (Single prime, single boost)Biological
Also called Aflunov
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (single prime, single boost)Biological
Also called Aflunov
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (single prime, single boost)Biological
Also called aflunov
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (Double prime, single boost)Biological
Also called aflunov
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (double prime, single boost)Biological
Also called aflunov
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (double prime, single boost)Biological
Also called aflunov
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (double prime, single boost)Biological
Also called aflunov
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (No prime, single boost)Biological
Also called aflunov
No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vaccine arm 1 | Active comparator | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks Receives: Biological: Aflunov (Single prime, single boost) |
| Vaccine arm 2 | Active comparator | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks Receives: Biological: Aflunov (Single prime, single boost) |
| Vaccine arm 3 | Active comparator | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks Receives: Biological: Aflunov (single prime, single boost) |
| Vaccine arm 4 | Active comparator | Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks Receives: Biological: Aflunov (single prime, single boost) |
| Vaccine arm 5 | Active comparator | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks Receives: Biological: Aflunov (Double prime, single boost) |
| vaccine arm 6 | Active comparator | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks Receives: Biological: Aflunov (double prime, single boost) |
| Vaccine arm 7 | Active comparator | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks Receives: Biological: Aflunov (double prime, single boost) |
| Vaccine arm 8 | Active comparator | Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks Receives: Biological: Aflunov (double prime, single boost) |
| Vaccine arm 9 | Active comparator | No priming dose and single dose MF59 adjuvanted H5N1 vaccine at 52 weeks Receives: Biological: Aflunov (No prime, single boost) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean antibody titres to influenza H5N1 by neutralising antibody, HI and SRH
Measured: pre vaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks, 56 weeks
Secondary outcomes (2)
local and systemic reactogenicity
Measured: within 7 days of each vaccination
Seroprotective and seroconversion responses to H5N1 by neutralising antibody, HI and SRH
Measured: Prevaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks and 56 weeks
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 startNov 2008
- Primary completionSep 2013
- Study completionDec 2013
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 1/2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Novartis, Public Health England, National Institute of Biological Standards and Control
- Responsible party
- Sponsor
- Investigators
- Karl G Nicholson, FRCP, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814385
- Sponsor's protocol ID
- UHL10492
- Status last verified
- Jun 2014
- First submitted
- 23 Dec 2008
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially Observer-blind, Single-centre Study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Influenza Vaccines in Adults Primed With Adjuvanted Influenza A/Vietnam/1194/04 (H5N1) Vaccine
- ClinicalTrials.gov ID
- NCT00814385
- Acronym / sponsor ID
- UHL10492
- Conditions
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Medical Research Council, Novartis, Public Health England, National Institute of Biological Standards and Control
- Study start
- Nov 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (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.
This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.
Detailed description
OBJECTIVES:
Immunogenicity objectives
- To evaluate the magnitude of the antibody responses to one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine, each dose containing 7.5μg of H5N1 haemagglutinin, in immunologically naïve subjects;
- To examine the kinetics of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75 or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
- To evaluate the magnitude of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75μg or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
- To evaluate the breadth of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above), with respect to a representative range of antigenically distinct H5N1 viruses (wild-type and attenuated); and
- To evaluate the persistence of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above).
Safety objective
- To evaluate the safety of the administration of one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (each dose containing 7.5μg of H5N1 haemagglutinin), in immunologically naïve subjects, followed by one 3.75μg or 7.5μg 'booster' dose of antigenically drifted MF59-adjuvanted H5N1 vaccine, or non-adjuvanted antigenically drifted H5N1 vaccine.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Vaccine arm 1 | Active comparator | Biological: Aflunov (Single prime, single boost)Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| Vaccine arm 2 | Active comparator | Biological: Aflunov (Single prime, single boost)Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| Vaccine arm 3 | Active comparator | Biological: Aflunov (single prime, single boost)Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 4 | Active comparator | Biological: Aflunov (single prime, single boost)Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 5 | Active comparator | Biological: Aflunov (Double prime, single boost)Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| vaccine arm 6 | Active comparator | Biological: Aflunov (double prime, single boost)Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks |
| Vaccine arm 7 | Active comparator | Biological: Aflunov (double prime, single boost)Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 8 | Active comparator | Biological: Aflunov (double prime, single boost)Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks |
| Vaccine arm 9 | Active comparator | Biological: Aflunov (No prime, single boost)No priming dose and single dose MF59 adjuvanted H5N1 vaccine at 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
- Are in good health or have one or more stable (See footnote) medical conditions, as determined by:
- Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
- Subjects who experienced fever (defined as axillary temperature >38oC) within 3 days prior to Visit 1;
- Subjects who are pregnant or breastfeeding;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Aflunov (Single prime, single boost)Also: AflunovPriming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks | Biological | Vaccine arm 1 |
| Aflunov (Single prime, single boost)Also: AflunovPriming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks | Biological | Vaccine arm 2 |
| Aflunov (single prime, single boost)Also: AflunovPriming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks | Biological | Vaccine arm 3 |
| Aflunov (single prime, single boost)Also: aflunovPriming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks | Biological | Vaccine arm 4 |
| Aflunov (Double prime, single boost)Also: aflunovPriming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks | Biological | Vaccine arm 5 |
| Aflunov (double prime, single boost)Also: aflunovPriming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks | Biological | vaccine arm 6 |
| Aflunov (double prime, single boost)Also: aflunovPriming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks | Biological | Vaccine arm 7 |
| Aflunov (double prime, single boost)Also: aflunovPriming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks | Biological | Vaccine arm 8 |
| Aflunov (No prime, single boost)Also: aflunovNo Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks | Biological | Vaccine arm 9 |
Primary outcome
Geometric mean antibody titres to influenza H5N1 by neutralising antibody, HI and SRH
Time frame: pre vaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks, 56 weeks
2 secondary outcomes
local and systemic reactogenicity
Time frame: within 7 days of each vaccination
Seroprotective and seroconversion responses to H5N1 by neutralising antibody, HI and SRH
Time frame: Prevaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks and 56 weeks
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 3 Jun 2014.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aflunov (Single prime, single boost), Aflunov (Double prime, single boost) and Aflunov (No prime, single boost) in people with Influenza, run by University Hospitals, Leicester at 2 sites 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 31 inclusion and 0 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 to influenza H5N1 by neutralising antibody, HI and SRH (time frame: pre vaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks, 56 weeks). 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 3 Jun 2014.