Respiratory Syncytial Virus (RSV)NCT03096574
Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
An observational study of Respiratory Syncytial Virus (RSV) and Maternal Vaccine Exposure, run by University Hospital Southampton NHS Foundation Trust at 4 sites in United Kingdom.
Trial summary
Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure, Attitude
- What is being tested?
- Questionnaire
- How many people
- 1,025 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jun 2017to Nov 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women and clinical staff at the four study sites
Who may be able to join
- Over the age of 16
- Under the care of staff working in: University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
- Able to read and write in English and give fully informed consent
- Over the age of 18
- Working in obstetrics or midwifery who regularly care for women in pregnancy at University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
- Able to read and write in English and give fully informed consent
Show all 9Show fewer
- General practitioners
- Fully-qualified and working in the UK
- Able to read and write in English and give fully informed consent
Who cannot join
- Women in active labour
- Women deemed acutely unwell or distressed
- Maternity healthcare professionals
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 3 recruiting
- Recruiting
Bristol University Hospitals
Bristol
Jane Metz
- Recruiting
St Georges Hospital
London
Anna Calvert
- Recruiting
Oxford University Hospitals
Oxford
Kirsten Beadon
- Completed
University Hosital Southampton NHS Foundation Trust
Southampton
About this study
Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy (maternal vaccination), which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection.
There are two main aims to this study:
Read more
- To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.
- We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)
The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at English teaching hospitals and GP practices. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination
Read the detailed description
Respiratory Syncytial Virus (RSV) is a very common virus that causes infection of the airways and lungs. It is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. Lots of research trials are being done into ways of preventing and treating RSV, however there is still no RSV vaccine approved for routine use. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy, which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection. There are two vaccines that are currently being tested in pregnant women around the world, including the UK.
There are two main aims to this study:
- To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.
- We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)
The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at four English teaching hospitals. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination
- Being tested
- Questionnaire
- Keywords
- Respiratory Syncytial Virus (RSV), Maternal vaccination, Attitudes, Pregnancy
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The participants will be approached by a member of the study team and, following recruitment, participants will be asked to fill in a short paper or online questionnaire. Our estimated time for completion is 5-10 minutes, and this time will be stated at the start of the questionnaire. Having completed the questionnaire they will be free to leave without further follow up, and given the contact details of the investigators/research governance office whom they can contact if they have further questions or concerns.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | * Over the age of 16
* Under the care of staff working in: University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
* Able to read and write in English and give fully informed consent Receives: Other: Questionnaire | |
| Maternity healthcare professionals | * Over the age of 18 * Working in obstetrics or midwifery who regularly care for women in pregnancy at University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust * Able to read and write in English and give fully informed consent | |
| UK General Practitioners | * Fully-qualified general practitioners practicing in the UK * Able to read and write in English and give fully informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Answers to questionnaires
The answers to the questionnaires will be analysed using statistical software to assess their knowledge of RSV, and identify factors that might affect their understanding of RSV and attitudes to being involved in hypothetical future trials and receiving the RSV vaccination.
Measured: Until data collection complete (December 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Jun 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
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 Syncytial Virus (RSV)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,025 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, St George's Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Christine Jones, Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096574
- Sponsor's protocol ID
- IRAS project ID: 220968
- Status last verified
- Nov 2018
- First submitted
- 24 Mar 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilcox CR, Calvert A, Metz J, Kilich E, MacLeod R, Beadon K, Heath PT, Khalil A, Finn A, Snape MD, Vandrevala T, Nadarzynski T, Coleman MA, Jones CE. Determinants of Influenza and Pertussis Vaccination Uptake in Pregnancy: A Multicenter Questionnaire Study of Pregnant Women and Healthcare Professionals. Pediatr Infect Dis J. 2019 Jun;38(6):625-630. doi: 10.1097/INF.0000000000002242.
PubMed 30418358Wilcox CR, Bottrell K, Paterson P, Schulz WS, Vandrevala T, Larson HJ, Jones CE. Influenza and pertussis vaccination in pregnancy: Portrayal in online media articles and perceptions of pregnant women and healthcare professionals. Vaccine. 2018 Nov 29;36(50):7625-7631. doi: 10.1016/j.vaccine.2018.10.092. Epub 2018 Nov 3.
PubMed 30401620
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
- ClinicalTrials.gov ID
- NCT03096574
- Acronym / sponsor ID
- IRAS project ID: 220968
- Keywords
- Respiratory Syncytial Virus (RSV), Maternal vaccination, Attitudes, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,025 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, St George's Healthcare NHS Trust
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 30 Mar 2017 (actual)
- 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.
Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy (maternal vaccination), which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection.
There are two main aims to this study:
- To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.
- We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)
The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at English teaching hospitals and GP practices. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination
Detailed description
Respiratory Syncytial Virus (RSV) is a very common virus that causes infection of the airways and lungs. It is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. Lots of research trials are being done into ways of preventing and treating RSV, however there is still no RSV vaccine approved for routine use. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy, which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection. There are two vaccines that are currently being tested in pregnant women around the world, including the UK.
There are two main aims to this study:
- To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.
- We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)
The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at four English teaching hospitals. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Questionnaire* Over the age of 16 * Under the care of staff working in: University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust * Able to read and write in English and give fully informed consent |
| Maternity healthcare professionals | – | –* Over the age of 18 * Working in obstetrics or midwifery who regularly care for women in pregnancy at University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust * Able to read and write in English and give fully informed consent |
| UK General Practitioners | – | –* Fully-qualified general practitioners practicing in the UK * Able to read and write in English and give fully informed consent |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women and clinical staff at the four study sites
Key inclusion criteria (9 listed)
- General practitioners
Key exclusion criteria (3 listed)
- Maternity healthcare professionals
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 |
|---|---|---|
| QuestionnaireThe participants will be approached by a member of the study team and, following recruitment, participants will be asked to fill in a short paper or online questionnaire. Our estimated time for completion is 5-10 minutes, and this time will be stated at the start of the questionnaire. Having completed the questionnaire they will be free to leave without further follow up, and given the contact details of the investigators/research governance office whom they can contact if they have further questions or concerns. | Other | Pregnant women |
Primary outcome
Answers to questionnaires
Time frame: Until data collection complete (December 2017)
The answers to the questionnaires will be analysed using statistical software to assess their knowledge of RSV, and identify factors that might affect their understanding of RSV and attitudes to being involved in hypothetical future trials and receiving the RSV vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Derived from this study: PubMed 30418358Wilcox CR, Calvert A, Metz J, Kilich E, MacLeod R, Beadon K, Heath PT, Khalil A, Finn A, Snape MD, Vandrevala T, Nadarzynski T, Coleman MA, Jones CE. Determinants of Influenza and Pertussis Vaccination Uptake in Pregnancy: A Multicenter Questionnaire Study of Pregnant Women and Healthcare Professionals. Pediatr Infect Dis J. 2019 Jun;38(6):625-630. doi: 10.1097/INF.0000000000002242.
- Derived from this study: PubMed 30401620Wilcox CR, Bottrell K, Paterson P, Schulz WS, Vandrevala T, Larson HJ, Jones CE. Influenza and pertussis vaccination in pregnancy: Portrayal in online media articles and perceptions of pregnant women and healthcare professionals. Vaccine. 2018 Nov 29;36(50):7625-7631. doi: 10.1016/j.vaccine.2018.10.092. Epub 2018 Nov 3.
- Individual participant dataSharing planned: No
Related trials for Respiratory Syncytial Virus (RSV)
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
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.
Christine Jones study chair
University Hospital Southampton NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV) and Maternal Vaccine Exposure, run by University Hospital Southampton NHS Foundation Trust at 4 sites 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 9 inclusion and 3 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 Christopher Wilcox (02381204956, christopher.wilcox@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Answers to questionnaires (time frame: Until data collection complete (December 2017)). 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 NCT03096574, 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 19 Nov 2018.