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. 2023 Jul 21;24:465. doi: 10.1186/s13063-023-07477-9
Criteria
Born at less than 37 weeks’ gestation
Birth weight < 2.5 kg or a present weight of < 3 kg at 6 weeks of age, as determined by a medical professional
Prior receipt of any vaccination except polio, hepatitis B, or BCG
Planned administration of vaccines other than the study vaccines (with the exception of vaccines against rotavirus, hepatitis A and B, inactivated influenza and varicella, which can be administered 14 days or 4 weeks in the case of two live viral vaccines (with the exception of polio) before or after study vaccines; polio and measles/rubella vaccines as part of national campaigns; and BCG vaccines which will be administered when indicated by national programme)
Parents who plan to move out of the geographical study area
Concurrently participating in another clinical study, which includes blood draws or IMPs, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
Any major congenital defects, serious chronic illness, significant disease, disorder, family history or diagnosis of an immunosuppressive condition, or medical treatments which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. (HIV and sickle cell are not exclusionary diagnoses in and of themselves)
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period
Known allergy to any vaccine components