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Opportunistic Pneumococcal Immunisation Trial in MALnutrition

RecruitingPhase 4Ages 6 Months - 59 MonthsAllNick Fancourt
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged 6-59 months at the time of hospitalisation 2. Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c): 1. weight-for-length/height z-score \<-3; or 2. middle upper arm circumference \<11.5cm; or 3. bilateral pitting pedal oedema unexplained by other causes 3. Parent/carer is willing for their child to participate in the study and has provided written informed consent 4. 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: 1. Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock. 2. Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial. 3. Suspected primary or secondary immunodeficiency or prolonged administration (\>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months. 4. Known terminal illness expected to result in death within 6 months. 5. 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. 6. Previously enrolled in this trial.
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What it tests

  • Pneumococcal conjugate vaccine
  • Typhoid conjugate vaccine
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Where

1 site
Guido Valadares National Hospital (HNGV)
Dili, Timor-Leste
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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