InfluenzaPhase 2NCT00522236
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects
A Phase 2 study testing Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008 in people with Influenza, run by Novartis Vaccines at 2 sites in Italy.
Trial summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2007to Jul 2007
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older
Who cannot join
- any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
- hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- known or suspected (or high risk of developing) impairment/alteration of immune function
- any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
- fever within the past 3 days
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Dipartimento di Medicina e Scienze dell'Invecchiamento
Chieti
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37
Lanciano, 66034
About this study
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
- Conditions
- Influenza
- Being tested
- Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
- Keywords
- Adjuvanted Influenza 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.
Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008Biological
A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:
- A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
- A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
- B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.
The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.
A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
The measures of immunogenicity for each antigen are:
- the geometric mean area (GMA) on Day 0 and Day 21
- the Day 21/Day 0 geometric mean area ratio (GMR)
- the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2
- the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21
- Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2.
- Significant increase in antibody titer is defined as at least a 50% increase in area.
Measured: 21 days post-vaccination
Secondary outcomes (1)
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Measured: 3 days, respectively 21 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2007
- Study completionJul 2007
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522236
- Sponsor's protocol ID
- V70P5S
- Other IDs
- 2007-000966-19
- Status last verified
- Jan 2012
- First submitted
- 28 Aug 2007
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
- ClinicalTrials.gov ID
- NCT00522236
- Acronym / sponsor ID
- V70P5S
- Conditions
- Influenza
- Keywords
- Adjuvanted Influenza Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Aug 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.
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years of age or older
Key exclusion criteria (6 listed)
- any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
- hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- known or suspected (or high risk of developing) impairment/alteration of immune function
- any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
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 |
|---|---|---|
| Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens: * A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain) * A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain) * B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season. The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes. A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm. | Biological | Arm 1 |
Primary outcome
Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
Time frame: 21 days post-vaccination
The measures of immunogenicity for each antigen are: * the geometric mean area (GMA) on Day 0 and Day 21 * the Day 21/Day 0 geometric mean area ratio (GMR) * the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 * the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21 1. Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. 2. Significant increase in antibody titer is defined as at least a 50% increase in area.
1 secondary outcome
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
Time frame: 3 days, respectively 21 days post-vaccination
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 25 Jan 2012.
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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 study chair
Novartis Vaccines
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008 in people with Influenza, run by Novartis Vaccines at 2 sites 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 6 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 25 Jan 2012. 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 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?
Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96) (time frame: 21 days post-vaccination). 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 25 Jan 2012.