Opportunistic Pneumococcal Immunisation Trial in MALnutrition
NCT ID: NCT06817421
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
214 participants
INTERVENTIONAL
2026-01-31
2029-02-28
Brief Summary
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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.
Detailed Description
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Participants will be randomised (1:1) to receive either a dose of a pneumococcal conjugate vaccine (Pneumosil, the intervention group) or a dose of a Typhoid conjugate vaccine (Typbar TCV, the control group). Stratification for randomisation will be done on (a) prior immunisation with a PCV (confirmed or unknown/unvaccinated); and (b) severity of malnurition (weight-for-height/length z-score \<-4 or \>=-4). Participants will be enrolled as soon as practical after admission to hospital, while randomisation and vaccine administration will occur once the participant is medically stable in the 'transition phase' of SAM care.
The primary objective is to demonstrate that immune responses to the 10 pneumococcal serotypes in Pneumosil are better in participants who receive Pneumosil, compared to those who receive Typbar TCV, when measured 28 days after vaccination.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Treatment Arm: Pneumosil
Pneumococcal conjugate vaccine
10-valent pneumococcal polysaccharide conjugate vaccine at a dosage of 2μg for each serotype polysaccharide for 1, 5, 6A, 7F, 9V, 14, 19A, 19F, 23F, and 4μg for serotype 6B, conjugated to a carrier protein (CRM197), polysorbate 20 and aluminium phosphate as an adjuvant. Administered as an intramuscular injection of 0.5mL.
Control Arm: Typbar TCV
Typhoid conjugate vaccine
Typhoid conjugate vaccine at a dosage of 25μg purified Vi capsular polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid with preservative (2-Phenoxyethanol). Administered as an intramuscular injection of 0.5mL.
Interventions
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Pneumococcal conjugate vaccine
10-valent pneumococcal polysaccharide conjugate vaccine at a dosage of 2μg for each serotype polysaccharide for 1, 5, 6A, 7F, 9V, 14, 19A, 19F, 23F, and 4μg for serotype 6B, conjugated to a carrier protein (CRM197), polysorbate 20 and aluminium phosphate as an adjuvant. Administered as an intramuscular injection of 0.5mL.
Typhoid conjugate vaccine
Typhoid conjugate vaccine at a dosage of 25μg purified Vi capsular polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid with preservative (2-Phenoxyethanol). Administered as an intramuscular injection of 0.5mL.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Months
59 Months
ALL
No
Sponsors
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Murdoch Childrens Research Institute
OTHER
The University of Western Australia
OTHER
University of Edinburgh
OTHER
Timor-Leste Ministry of Health
UNKNOWN
Nick Fancourt
OTHER
Responsible Party
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Nick Fancourt
Senior Research Fellow
Locations
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Guido Valadares National Hospital (HNGV)
Dili, Timor-Leste, Timor-Leste
Countries
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Central Contacts
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Related Links
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Pneumosil product information
Typbar-TCV product information
Other Identifiers
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U1111-1312-6848
Identifier Type: OTHER
Identifier Source: secondary_id
MENTL2024-4996
Identifier Type: -
Identifier Source: org_study_id