Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

NCT03096574 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1025

Last updated 2018-11-19

No results posted yet for this study

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. 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:

1. 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.
2. 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

Conditions

  • Respiratory Syncytial Virus (RSV)
  • Maternal Vaccine Exposure
  • Attitude

Interventions

OTHER

Questionnaire

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.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    collaborator OTHER
  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER
  • St George's Healthcare NHS Trust

    collaborator OTHER
  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Christine Jones · University Hospital Southampton NHS Foundation Trust

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096574 on ClinicalTrials.gov