Pneumococcal Vaccine Test for severely malnourished kids in hospital

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, double-blind randomized trial enrolling 264 children aged 6–59 months hospitalized with severe acute malnutrition. Participants are randomized 1:1 to receive Pneumosil (pneumococcal vaccine) or Typbar TCV (typhoid vaccine) during a stable in-hospital period, with stratification by prior PCV vaccination and malnutrition severity. The primary endpoint is the antibody response to 10 pneumococcal serotypes 28 days after vaccination. After vaccination, participants have four home visits over six months and a phone check at 12 months. The study aims to determine if Pneumosil induces a superior immune response compared to Typbar TCV in this high-risk population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guido Valadares National Hospital (HNGV)
  Dili, Timor-Leste Recruiting

Study contacts

• Study coordinator: Nicholas S. S. Fancourt, PhD
• Email: nick.fancourt@menzies.edu.au
• Phone: +61889468600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New pneumococcal vaccine safety and immune response in children and teens

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• New pneumococcal vaccine in infants shows safety and how it stacks up against Prevnar 20

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• New pneumococcal vaccine for healthy infants

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• V118C pneumococcal vaccine in infants and toddlers

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• Serum collection after Gamma-PN vaccination to support assay development

  This project will collect blood samples from people who receive the Gamma-PN vaccine to help develop lab tests for pneumococcal disease.

  Recruiting Phase 1 GPN Vaccines · Adelaide, South Australia · NCT07205289

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.