H1N1 VirusSnufflesNCT01192958
A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza
An observational study of H1N1 Virus, run by Public Health England.
Trial summary
At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- H1N1 Virus
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2010
- Phase
- Observational
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects from primary care who are participating in the clinical service evaluation.
Who may be able to join
- Participants of the clinical service evaluation of novel H1N1v vaccine
- First or second blood sample for the clinical service evaluation successfully collected
Who cannot join
- Withdrawn from clinical service evaluation of novel H1N1v vaccine
- Second blood sample for the clinical service evaluation not collected.
About this study
At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. If such a test were available, this painless and non invasive test will improve direct clinical care to an individual as well as significantly help guide future public health management of the pandemic.
- Conditions
- H1N1 Virus
- Keywords
- swine flu, novel h1n1v, novel h1n1, h1n1
- Medical subject headings
- Orthomyxoviridae Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H1N1 VirusStudies 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
- Observational
- Observational model
- Case only
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192958
- Sponsor's protocol ID
- OFLU
- Acronym
- Snuffles
- Status last verified
- Dec 2009
- First submitted
- 31 Aug 2010
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza
- ClinicalTrials.gov ID
- NCT01192958
- Acronym / sponsor ID
- Snuffles / OFLU
- Conditions
- H1N1 Virus
- Keywords
- swine flu, novel h1n1v, novel h1n1, h1n1
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Sep 2010 (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.
At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. If such a test were available, this painless and non invasive test will improve direct clinical care to an individual as well as significantly help guide future public health management of the pandemic.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects from primary care who are participating in the clinical service evaluation.
Key inclusion criteria (2 listed)
- Participants of the clinical service evaluation of novel H1N1v vaccine
- First or second blood sample for the clinical service evaluation successfully collected
Key exclusion criteria (2 listed)
- Withdrawn from clinical service evaluation of novel H1N1v vaccine
- Second blood sample for the clinical service evaluation not collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Sep 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of H1N1 Virus, run by Public Health England.
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 2 inclusion and 2 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 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 1 Sep 2010.