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Group B Streptococcus: Attitudes to Immunisation in Pregnancy

NCT01982084 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 758

Last updated 2018-04-05

No results posted yet for this study

Summary

Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development.

Vaccinating pregnant women against GBS in order to protect their newborn babies is a promising area of research.However, many women are reluctant to accept vaccination during pregnancy for fear it will harm their unborn child and there is often a lack of understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive experience of immunisation against pertussis in the United Kingdom, suggest that antenatal immunisation can be acceptable.

Previous research has shown that advice from maternity healthcare professionals regarding vaccination is highly valued by pregnant women so it is also important to explore the attitudes and opinions of this group.

The objective of this study is to assess the knowledge and attitudes of pregnant women and maternity healthcare professionals in England and Scotland regarding GBS disease and the acceptability of a potential vaccine.

There are two parts to this study. The first part will invite pregnant women, maternity healthcare professionals and parents who have had a child affected by GBS disease to take part in either a focus group or an individual interview.

This will allow for an in-depth exploration of the participants thoughts and opinions about GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site only. The results will guide the development of a self completed, paper questionnaire which will be distributed to a wider range of pregnant women and maternity healthcare professionals across four different study sites.

This study has been funded by Meningitis UK. Additional collaborators to those listed include the charity Group B Strep Support.

Conditions

  • Immunisation During Pregnancy
  • Group B Streptococcus

Sponsors & Collaborators

  • St George's, University of London

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • Royal Infirmary of Edinburgh

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Matthew Snape, MBBS FRCPCH · University of Oxford

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-03-31
Completion
2014-03-29

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 NCT01982084 on ClinicalTrials.gov