Respiratory Syncyctial Virus VaccinesNCT01706302
Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009
An observational study of Respiratory Syncyctial Virus Vaccines, run by GlaxoSmithKline.
Trial summary
The study will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Syncyctial Virus Vaccines
- What is being tested?
- Data collection
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects included in the 116273 study who were registered with an acceptable flag in the CPRD, or with a potentially RSV-related event in the HES database or the ONS mortality data.
Who may be able to join
- Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.
Who cannot join
- Not Applicable
About this study
Official title: Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom, 1995 to 2009
The study will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.
Read the detailed description
This epidemiological study is based on an already existing database of time series regression modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study, which estimated the burden of influenza in terms of General Practitioner (GP) consultations, hospitalizations, and deaths associated with various respiratory and non-respiratory outcomes.
- Conditions
- Respiratory Syncyctial Virus Vaccines
- Being tested
- Data collection
- Keywords
- General Practice Research Database, Burden of Disease, Clinical Practice Research Datalink, Hospital Episode Statistics, Office of National Statistics, RSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
The previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.
Measured: From 1995 to 2009
Secondary outcomes (4)
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes.
Measured: From 1995 to 2009
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group.
Measured: From 1995 to 2009
Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.
Measured: From 1995 to 2009
Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.
Measured: From 1995 to 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncyctial Virus VaccinesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sage Analytica
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706302
- Sponsor's protocol ID
- 116357
- Status last verified
- Apr 2013
- First submitted
- 11 Oct 2012
- Last updated
- 29 Apr 2013
- Results posted
- No
Publications
Taylor S, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Fleming DM. Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open. 2016 Jun 2;6(6):e009337. doi: 10.1136/bmjopen-2015-009337.
PubMed 27256085Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z.
PubMed 26497750
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom, 1995 to 2009
- ClinicalTrials.gov ID
- NCT01706302
- Acronym / sponsor ID
- 116357
- Conditions
- Respiratory Syncyctial Virus Vaccines
- Keywords
- General Practice Research Database, Burden of Disease, Clinical Practice Research Datalink, Hospital Episode Statistics, Office of National Statistics, RSV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Sage Analytica
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Oct 2012 (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 will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.
Detailed description
This epidemiological study is based on an already existing database of time series regression modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study, which estimated the burden of influenza in terms of General Practitioner (GP) consultations, hospitalizations, and deaths associated with various respiratory and non-respiratory outcomes.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Group | – | Other: Data collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects included in the 116273 study who were registered with an acceptable flag in the CPRD, or with a potentially RSV-related event in the HES database or the ONS mortality data.
Key inclusion criteria (1 listed)
- Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.
Key exclusion criteria (1 listed)
- Not Applicable
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 |
|---|---|---|
| Data collectionThe previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group. | Other | Cohort Group |
Primary outcome
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.
Time frame: From 1995 to 2009
4 secondary outcomes
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes.
Time frame: From 1995 to 2009
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group.
Time frame: From 1995 to 2009
Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.
Time frame: From 1995 to 2009
Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.
Time frame: From 1995 to 2009
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 Apr 2013.
- Derived from this study: PubMed 27256085Taylor S, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Fleming DM. Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open. 2016 Jun 2;6(6):e009337. doi: 10.1136/bmjopen-2015-009337.
- Derived from this study: PubMed 26497750Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z.
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncyctial Virus Vaccines, run by GlaxoSmithKline.
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 1 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 Apr 2013. 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.
What does the primary outcome measure?
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes. (time frame: From 1995 to 2009). 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 NCT01706302, which also lists 2 linked publications.
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 Apr 2013.