InfluenzaPhase 4CMVfluNCT00442975
Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status
A Phase 4 study testing Fluarix in people with Influenza, run by Public Health England at 1 site in United Kingdom.
Trial summary
The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluarix
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Sep 2007
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- Written informed consent obtained
- Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Single Group Study to Evaluate the Immune Response to Licensed Seasonal Influenza Vaccine and Relationship of This to Cytomegalovirus-associated Immunosenescence in UK Older Adults Aged 50-80 Years
The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of HIV infection. CMV is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.
Read the detailed description
Human cytomegalovirus (HCMV) is an important pathogen or disease-causing virus, which can result in disease in the unborn child as well as in individuals whose immune systems are not working properly such as those with HIV or who are receiving some treatments for cancer, where the body's ability to fight infection is not as good as in healthy people. HCMV infects the majority of the population, yet rarely causes overt disease which would limit the capacity of the host to transmit HCMV to others. This virus is thought to be millions of years old and because of this we think that it has evolved over time to become very efficient at evading the immune system. This means it has become very efficient at moving through the human population and resulting in humans devoting more immunological resources to controlling this virus than to any other. Recent studies have reported that the immune system does work less efficiently in older people, especially in elderly patients with CMV antibodies compared to age matched controls who did not have CMV antibodies.
It is well recognized that responses to vaccination are generally lower in older populations compared to children, so they may be thought to be immunologically in a suboptimal position. It is proposed that this may be as a result of diversion of key factors in the immune system to address CMV infection, the incidence of which increases with age. This study will allow assessment of responses to licensed seasonal influenza vaccine with respect to age and CMV status and will provide baseline information as a proof of principle on which a larger study will be designed.
- Conditions
- Influenza
- Being tested
- Fluarix
- Keywords
- Influenza Vaccine, CMV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluarixBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to influenza vaccination (HI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startMar 2007
- Study completionSep 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Collaborators
- Royal Free and University College Medical School
- Investigators
- Elizabeth Miller, MBBS FRCPath, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442975
- Sponsor's protocol ID
- CMVfluvaccinees
- Other IDs
- EudraCT No: 2006-006563-23
- Acronym
- CMVflu
- Status last verified
- Feb 2008
- First submitted
- 2 Mar 2007
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single Group Study to Evaluate the Immune Response to Licensed Seasonal Influenza Vaccine and Relationship of This to Cytomegalovirus-associated Immunosenescence in UK Older Adults Aged 50-80 Years
- ClinicalTrials.gov ID
- NCT00442975
- Acronym / sponsor ID
- CMVflu / CMVfluvaccinees
- Conditions
- Influenza
- Keywords
- Influenza Vaccine, CMV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Collaborators
- Royal Free and University College Medical School
- Study start
- Mar 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Mar 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.
The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of HIV infection. CMV is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.
Detailed description
Human cytomegalovirus (HCMV) is an important pathogen or disease-causing virus, which can result in disease in the unborn child as well as in individuals whose immune systems are not working properly such as those with HIV or who are receiving some treatments for cancer, where the body's ability to fight infection is not as good as in healthy people. HCMV infects the majority of the population, yet rarely causes overt disease which would limit the capacity of the host to transmit HCMV to others. This virus is thought to be millions of years old and because of this we think that it has evolved over time to become very efficient at evading the immune system. This means it has become very efficient at moving through the human population and resulting in humans devoting more immunological resources to controlling this virus than to any other. Recent studies have reported that the immune system does work less efficiently in older people, especially in elderly patients with CMV antibodies compared to age matched controls who did not have CMV antibodies.
It is well recognized that responses to vaccination are generally lower in older populations compared to children, so they may be thought to be immunologically in a suboptimal position. It is proposed that this may be as a result of diversion of key factors in the immune system to address CMV infection, the incidence of which increases with age. This study will allow assessment of responses to licensed seasonal influenza vaccine with respect to age and CMV status and will provide baseline information as a proof of principle on which a larger study will be designed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
- Written informed consent obtained
- Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment.
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 |
|---|---|---|
| Fluarix | Biological | – |
Primary outcome
Response to influenza vaccination (HI)
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 29 Aug 2018.
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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.
Elizabeth Miller, MBBS FRCPath principal investigator
Public Health England
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 Fluarix in people with Influenza, run by Public Health England 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 3 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 29 Aug 2018. 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 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?
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?
Response to influenza vaccination (HI). 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 29 Aug 2018.