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Opportunistic Pneumococcal Immunisation Trial in MALnutrition

NCT06817421 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Severe Acute Malnutrition in Childhood
  • Pneumococcal Disease
  • Pneumococcal Vaccines
  • Pneumococcal Infection
  • Pneumonia in Children

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.

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    collaborator OTHER

  • The University of Western Australia

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • Timor-Leste Ministry of Health

    collaborator UNKNOWN

  • Nick Fancourt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-03-31
Completion
2029-02-28

Countries

  • Timor-Leste

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06817421 on ClinicalTrials.gov