Prophylaxis of Avian Influenza VaccinePhase 2NCT00478816
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines
A Phase 2 study testing Fluad H5N1 Pandemic Influenza Vaccine in people with Prophylaxis of Avian Influenza Vaccine, run by Novartis Vaccines at 1 site in United Kingdom.
Trial summary
Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis of Avian Influenza Vaccine
- What is being tested?
- Fluad H5N1 Pandemic Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to Feb 2009
- Phase
- Phase 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 to 65 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
- In good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the Investigator;
- Subjects in the primed group previously received at least two doses of an H5N3 vaccine;
- Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
Who cannot join
- Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
- Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
- Subjects who experienced fever (defined as axillary temperature ≥38.0°C) 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 the duration of the study. 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), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
- Subjects with any serious disease, such as:
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- cancer,
- autoimmune disease (including rheumatoid arthritis),
- diabetes mellitus,
- chronic pulmonary disease,
- acute or progressive hepatic disease,
- acute or progressive renal disease;
- Subjects for whom a surgery is planned during the study period;
- Subjects with bleeding diathesis;
- Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
- Subjects with a history of any neurological symptoms or 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 immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
- high risk for developing an immunocompromising disease;
- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
- Subjects with a history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
- Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single Center, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With MF59-adjuvanted or Non-adjuvanted H5N3 Influenza Vaccines
Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects
- Conditions
- Prophylaxis of Avian Influenza Vaccine
- Being tested
- Fluad H5N1 Pandemic Influenza Vaccine
- Keywords
- Bird flu, influenza vaccine, prepandemic vaccine
- Medical subject headings
- Influenza in Birds, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluad H5N1 Pandemic Influenza VaccineBiological
Also called Vaccine
Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Primed subject with pandemic Vaccine Receives: Biological: Fluad H5N1 Pandemic Influenza Vaccine |
| Group 2 | Active comparator | Non Primed subject with pandemic Vaccine Receives: Biological: Fluad H5N1 Pandemic Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-mediated immunity, magnitude, breath and kinetics of antibody response to 2 doses of MF59-adjuvanted H5N1 influenza vaccine, in subjects primed by previous vaccination with either MF59-adjuvanted or non-adjuvanted H5N3 influenza vaccine.
Measured: Days 1, 8, 15, 22, 43 and 202
Secondary outcomes (1)
Safety Objectives: safety and reactogenicity of the vaccine
Measured: Days 1, 8, 15, 22, 43 and 202
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prophylaxis of Avian Influenza VaccineStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines Information Service +41 61 324 1111, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478816
- Sponsor's protocol ID
- V87P3
- Status last verified
- Feb 2012
- First submitted
- 24 May 2007
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Galli G, Hancock K, Hoschler K, DeVos J, Praus M, Bardelli M, Malzone C, Castellino F, Gentile C, McNally T, Del Giudice G, Banzhoff A, Brauer V, Montomoli E, Zambon M, Katz J, Nicholson K, Stephenson I. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7962-7. doi: 10.1073/pnas.0903181106. Epub 2009 Apr 27.
PubMed 19416838
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Center, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With MF59-adjuvanted or Non-adjuvanted H5N3 Influenza Vaccines
- ClinicalTrials.gov ID
- NCT00478816
- Acronym / sponsor ID
- V87P3
- Conditions
- Prophylaxis of Avian Influenza Vaccine
- Keywords
- Bird flu, influenza vaccine, prepandemic vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 25 May 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.
Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Fluad H5N1 Pandemic Influenza VaccinePrimed subject with pandemic Vaccine |
| Group 2 | Active comparator | Biological: Fluad H5N1 Pandemic Influenza VaccineNon Primed subject with pandemic Vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged 18 to 65 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
- In good health as determined by:
- Subjects in the primed group previously received at least two doses of an H5N3 vaccine;
- Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
Key exclusion criteria (24 listed)
- Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
- Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
- Subjects who experienced fever (defined as axillary temperature ≥38.0°C) 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 the duration of the study. 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), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
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 |
|---|---|---|
| Fluad H5N1 Pandemic Influenza VaccineAlso: VaccineTwo 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm. | Biological | Group 1, Group 2 |
Primary outcome
Cell-mediated immunity, magnitude, breath and kinetics of antibody response to 2 doses of MF59-adjuvanted H5N1 influenza vaccine, in subjects primed by previous vaccination with either MF59-adjuvanted or non-adjuvanted H5N3 influenza vaccine.
Time frame: Days 1, 8, 15, 22, 43 and 202
1 secondary outcome
Safety Objectives: safety and reactogenicity of the vaccine
Time frame: Days 1, 8, 15, 22, 43 and 202
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 1 Dec 2016.
- Results publication: PubMed 19416838Galli G, Hancock K, Hoschler K, DeVos J, Praus M, Bardelli M, Malzone C, Castellino F, Gentile C, McNally T, Del Giudice G, Banzhoff A, Brauer V, Montomoli E, Zambon M, Katz J, Nicholson K, Stephenson I. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7962-7. doi: 10.1073/pnas.0903181106. Epub 2009 Apr 27.
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.
Novartis Vaccines Information Service +41 61 324 1111 study chair
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluad H5N1 Pandemic Influenza Vaccine in people with Prophylaxis of Avian Influenza Vaccine, run by Novartis Vaccines 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 7 inclusion and 24 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 1 Dec 2016. 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 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?
Cell-mediated immunity, magnitude, breath and kinetics of antibody response to 2 doses of MF59-adjuvanted H5N1 influenza vaccine, in subjects primed by previous vaccination with either MF59-adjuvanted or non-adjuvanted H5N3 influenza vaccine. (time frame: Days 1, 8, 15, 22, 43 and 202). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478816, which also lists 1 linked publication.
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 1 Dec 2016.