Immunogenicity of Opportunistic Pneumococcal Conjugate Vaccination (Pneumosil®) Versus Control (Typhoid Conjugate Vaccine, Typbar TCV®) in Children Aged 6-59 Months Hospitalised With Severe Acute Malnutrition: a Single-centre, Double-blind, Randomised Controlled Trial in Timor-Leste
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
• Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c):
‣ weight-for-length/height z-score \<-3; or
⁃ middle upper arm circumference \<11.5cm; or
⁃ bilateral pitting pedal oedema unexplained by other causes
• Parent/carer is willing for their child to participate in the study and has provided written informed consent
• Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study