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Participant information for the OpTIMUM study

online resource
posted on 07.05.2021, 08:30 by Anna CalvertAnna Calvert
These materials are the informed consent forms, participant information sheets (PIS) and questionnaire for the OpTIMUM study (Optimising Timing of whooping cough Immunisation in MUMs).

Pertussis is a highly infectious respiratory illness caused by the bacteria Bordetella pertussis. A resurgence of pertussis, even in countries with good vaccine coverage, has led to an increase in infant deaths. In response to this, many countries have introduced pertussis vaccination in pregnancy. This strategy is effective at preventing infant disease, but there remains uncertainty about what gestational timing is best to ensure maximal protection of the infant. These uncertainties are the rationale for this randomised controlled trial and a sub-study investigating pertussis-specific antibody in breastmilk.

There are different informed consent forms and participant information sheets for the two sites which participated in the breastmilk sub-study and the remaining sites which did not.

Breastmilk and non-breastmilk sites
Participants for the breastmilk sub-study were only recruited from Southampton and St George's. To ensure that participants at these sites received the correct information, we used different PIS and Informed Consent Forms (ICF) at the sites participating in the breastmilk sub-study and the sites not participating in the sub-study.

The filenames in the materials indicate which PIS and ICF were provided to which sites.

ICF and PIS non-breastmilk sites: Manchester, Bristol, Kingston, Oxford
ICF and PIS breastmilk sites: Southampton and St George's

Funding

Thrasher Research Fund

National Immunisation Schedule Evaluation Consortium

History

Research Institute

Infection and Immunity