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NOT YET RECRUITING
NCT06817421
PHASE4

Opportunistic Pneumococcal Immunisation Trial in MALnutrition

Sponsor: Nick Fancourt

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2026-01

Completion Date

2029-02

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

Locations (1)

Guido Valadares National Hospital (HNGV)

Dili, Timor-Leste, Timor-Leste