Immune ResponsePhase 4Expand IDWP21NCT01289535
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
A Phase 4 study testing Blood sample in people with Immune Response, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 4
- 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
- Subject aged 65 years or over
- Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit
- Legal capacity to consent
- Subject had given written consent before his participation
Who cannot join
- Adjuvanted influenza vaccine (e.g: Fluad, Gripguard)
- Live vaccines within 3 weeks before and after influenza vaccination
- Inactivated vaccines within 2 weeks before and after influenza vaccination
- Chronic disease non-stabilized under treatment
- Severe malnutrition in the opinion of the investigator
- Congenital immunodeficiency
Show all 9Show fewer
- Chemotherapy or radiotherapy over the last 6 months
- Immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent >/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit
- Participation in another clinical study that could interfere with the present study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie
Pierre-Bénite, 69495
Catherine GOUJON, Dr, +33 478 86 41 25, catherine.goujon@chu-lyon.fr
Catherine GOUJON, Dr
About this study
This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.
Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.
Read more
Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.
However, the immune response to influenza vaccine appears to be lower in elderly than in young people.
- Conditions
- Immune Response
- Being tested
- Blood sample
- Keywords
- Influenza vaccine, immune response, elderly
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Blood sample of 7 ml
| Study group | Role | What they receive |
|---|---|---|
| antibody rates | Experimental | Not described Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody rates after influenza vaccination
Measured: up to 3 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289535
- Sponsor's protocol ID
- 2010.621
- Acronym
- Expand IDWP21
- Status last verified
- Dec 2011
- First submitted
- 2 Feb 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
- ClinicalTrials.gov ID
- NCT01289535
- Acronym / sponsor ID
- Expand IDWP21 / 2010.621
- Conditions
- Immune Response
- Keywords
- Influenza vaccine, immune response, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 3 Feb 2011 (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 is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.
Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.
Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.
However, the immune response to influenza vaccine appears to be lower in elderly than in young people.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antibody rates | Experimental | Procedure: Blood sample |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subject aged 65 years or over
- Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit
- Legal capacity to consent
- Subject had given written consent before his participation
Key exclusion criteria (9 listed)
- Adjuvanted influenza vaccine (e.g: Fluad, Gripguard)
- Live vaccines within 3 weeks before and after influenza vaccination
- Inactivated vaccines within 2 weeks before and after influenza vaccination
- Chronic disease non-stabilized under treatment
- Severe malnutrition in the opinion of the investigator
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 |
|---|---|---|
| Blood sampleBlood sample of 7 ml | Procedure or surgery | antibody rates |
Primary outcome
antibody rates after influenza vaccination
Time frame: up to 3 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood sample in people with Immune Response, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Dec 2011. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine GOUJON, Dr (+33 478 86 41 25, catherine.goujon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibody rates after influenza vaccination (time frame: up to 3 months after 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 30 Dec 2011.