Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Timor-Leste214 participantsStarted 2026-01
Plain-language summary
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.
Who can participate
Age range6 Months – 59 Months
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Serotype-specific immunoglobulin G (IgG) antibodies
✕. 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.
✕. Participants who, in the opinion of the site Principal Investigator, are unable to comply with the study protocol, including scheduled visits, assessments, and any other protocol-required procedures.