InfluenzaPhase 2NCT00382187
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
A Phase 2 study testing MF59 adjuvanted H5N1 influenza vaccine in people with Influenza, run by Novartis Vaccines at 1 site in Italy.
Trial summary
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- MF59 adjuvanted H5N1 influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2006to Jan 2008
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female volunteers 18-60 years of age
Who cannot join
- Any auto-immune disease or other serious acute, chronic or progressive disease
- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
Siena, Siena, 53100
About this study
Official title: A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
- Conditions
- Influenza
- Being tested
- MF59 adjuvanted H5N1 influenza vaccine
- Keywords
- influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen, MF59, Pandemic influenza disease
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59 adjuvanted H5N1 influenza vaccineBiological
- MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
- non-adjuvanted influenza vaccine containing 15 ug of H5N1
| Study group | Role | What they receive |
|---|---|---|
| MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms | Experimental | Not described Receives: Biological: MF59 adjuvanted H5N1 influenza vaccine |
| MF59 adjuvant H5N1 influenza vaccine 15 micrograms | Experimental | Not described Receives: Biological: MF59 adjuvanted H5N1 influenza vaccine |
| non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen | Experimental | Not described Receives: Biological: MF59 adjuvanted H5N1 influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
Measured: day 1 to day 43
Secondary outcomes (1)
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
Measured: Day 1 to Day 382
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2008
- Study completionJan 2008
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 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines - Information Services, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382187
- Sponsor's protocol ID
- V87P2
- Other IDs
- Eudract number 2006-004063-66
- Status last verified
- Feb 2012
- First submitted
- 27 Sep 2006
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.
PubMed 19237568
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, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults
- ClinicalTrials.gov ID
- NCT00382187
- Acronym / sponsor ID
- V87P2
- Conditions
- Influenza
- Keywords
- influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen, MF59, Pandemic influenza disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 28 Sep 2006 (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.
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms | Experimental | Biological: MF59 adjuvanted H5N1 influenza vaccine |
| MF59 adjuvant H5N1 influenza vaccine 15 micrograms | Experimental | Biological: MF59 adjuvanted H5N1 influenza vaccine |
| non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen | Experimental | Biological: MF59 adjuvanted H5N1 influenza vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female volunteers 18-60 years of age
Key exclusion criteria (4 listed)
- Any auto-immune disease or other serious acute, chronic or progressive disease
- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy
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 |
|---|---|---|
| MF59 adjuvanted H5N1 influenza vaccine* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 * non-adjuvanted influenza vaccine containing 15 ug of H5N1 | Biological | MF59 adjuvant H5N1 influenza vaccine 15 micrograms, MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms, non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen |
Primary outcome
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
Time frame: day 1 to day 43
1 secondary outcome
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
Time frame: Day 1 to Day 382
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 19237568Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.
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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.
Novartis Vaccines - Information Services 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 MF59 adjuvanted H5N1 influenza vaccine in people with Influenza, run by Novartis Vaccines at 1 site in Italy.
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 1 inclusion and 4 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 Italy. 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?
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination. (time frame: day 1 to day 43). 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 NCT00382187, 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.