The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition.
Researchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV). To ensure all participants receive timely potential benefits, at 3 months participants in the intervention group with receive a dose of Typbar TCV, and those in the conrol group will receive a dose of Pneumosil.
Participants will be visited 4 times at their homes over six months after vaccination, with a phone review at 12 months after vaccination.
Aged 6-59 months at the time of hospitalisation
weight-for-length/height z-score <-3; or
middle upper arm circumference <11.5cm; or
bilateral pitting pedal oedema unexplained by other causes
Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.
Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.
Suspected primary or secondary immunodeficiency or prolonged administration (>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.
Known terminal illness expected to result in death within 6 months.
Nick Fancourt
Lead sponsor
Menzies School of Health Research
Sponsor institution
Murdoch Childrens Research Institute
Collaborator
The University of Western Australia
Collaborator
University of Edinburgh
Collaborator
Timor-Leste Ministry of Health
Collaborator