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. 2023 Nov 14;13(11):e072938. doi: 10.1136/bmjopen-2023-072938

Table 2.

Summary of Salmonella Vaccine Study in Oxford inclusion and exclusion criteria

Inclusion criteria Willing and able to give informed consent for participation in the study
Aged between 18 and 55 years inclusive
In good health as determined by:
  • Medical history

  • Physical examination

  • Laboratory assessment

  • Clinical judgement of the investigators

Willing to use highly effective contraception from 1 month prior to receiving the first vaccine and for the duration of the study (females)
Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
Willing to allow his or her general practitioner and/or consultant, if appropriate, to be notified of participation in the study
Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
Exclusion criteria History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators
Have any known or suspected impairment or alteration of immune function
Study significant abnormalities on screening investigations that are either unlikely to resolve or do not resolve on repeat testing
Prior history of receipt of an oral typhoid vaccine (eg, Ty21a) within the last 3 years or a paratyphoid vaccine (as part of a clinical trial)
Prior history of participation in a typhoid or paratyphoid controlled human infection study*
Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
Plan to receive any vaccine other than the study vaccine within 4 weeks after any study vaccination (except for COVID-19 vaccines)
History of allergy or anaphylaxis to a previous vaccine or vaccine components
Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
Participation in another research study involving an investigational product or that which may compromise the integrity of the study
Inability, in the opinion of the investigator, to comply with all study requirements including likelihood of successful venepuncture during the trial
Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study
Weight less than 50 kg or a BMI<18.4 kg/m2 or a BMI>40 kg/m2
Any other significant disease or disorder which, in the opinion of the investigator, may:
  • Put the participants at risk because of participation in the study

  • Influence the result of the study

  • Impair the participant’s ability to participate in the study

*Future studies in typhoid or paratyphoid endemic countries may consider including a history of S. Typhi or S. Paratyphi natural infection as an exclusion. This was not included in this study as the risk of prior natural infection was considered low.