Severe Acute Malnutrition in ChildhoodPhase 4OPTIMALNCT06817421
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
A Phase 4 study testing Pneumococcal conjugate vaccine and Typhoid conjugate vaccine in people with Severe Acute Malnutrition in Childhood and Pneumococcal Disease, run by Nick Fancourt at 1 site in Timor-Leste.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition in Childhood, Pneumococcal Disease, Pneumococcal Vaccines
- What is being tested?
- Pneumococcal conjugate vaccine and Typhoid conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTimor-Leste
- Study dates
- 16 Jan 2026to Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-59 months at the time of hospitalisation
- Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c):
- weight-for-length/height z-score <-3; or
- middle upper arm circumference <11.5cm; or
- bilateral pitting pedal oedema unexplained by other causes
- Parent/carer is willing for their child to participate in the study and has provided written informed consent
- Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study
Who cannot join
- Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.
- Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.
- Suspected primary or secondary immunodeficiency or prolonged administration (>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.
- Known terminal illness expected to result in death within 6 months.
- 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.
- Previously enrolled in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Timor-Leste1 site, 1 recruiting
- Recruiting
Guido Valadares National Hospital (HNGV)
Dili
About this study
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
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.
Read the detailed description
This is a prospective, single-centre, double-blind, randomised controlled trial in 264 children aged 6-59 months hospitalised with severe acute malnutrition.
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
- Severe Acute Malnutrition in Childhood, Pneumococcal Disease, Pneumococcal Vaccines, Pneumococcal Infection, Pneumonia in Children
- Being tested
- Pneumococcal conjugate vaccine, Typhoid conjugate vaccine
- Keywords
- Pneumococcal, Severe Acute Malnutrition in childhood, Pneumococcal vaccine, Pneumosil, Pneumococcal disease, Pneumococcal infection, Pneumonia
- Medical subject headings
- Pneumococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal conjugate vaccineBiological
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 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm: Pneumosil | Experimental | Not described Receives: Biological: Pneumococcal conjugate vaccine |
| Control Arm: Typbar TCV | Other | Not described Receives: Biological: Typhoid conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotype-specific immunoglobulin G (IgG) antibodies
Pneumosil serotype-specific (1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 23F) immunoglobulin G (IgG) geometric mean concentrations (GMCs).
Measured: 4 weeks after vaccination
Secondary outcomes (12)
Serotype-specific IgG antibodies
Pneumosil serotype-specific IgG GMCs
Measured: 4 weeks and 3 months after vaccination
Proportion of participants with serotype-specific IgG antibody responses ≥ 0.35 μg/mL
Proportion of participants with Pneumosil serotype-specific IgG concentrations ≥ 0.35μg/mL
Measured: 4 weeks and 3 months after vaccination
Functional antibody responses
Pneumosil serotype-specific pneumococcal geometric mean opsonisation indices (GMOIs)
Measured: 4 weeks and 3 months after vaccination
Functional antibody responses
Proportion of participants with Pneumosil serotye-specfiic pneumococcal opsonisation indices (OIs) >8
Measured: 4 weeks and 3 months after vaccination
Salivary IgG antibodies
Serotype-specific salivary IgG (μg/ml) for Pneumosil serotypes and non-vaccine types 3, 4, 11A, and 18C
Measured: 4 weeks and 3 months after vaccination
Salivary immunoglobulin A (IgA) antibodies
Serotype-specific salivary IgA (μg/ml) for Pneumosil serotypes and non-vaccine types 3, 4, 11A, and 18C
Measured: 4 weeks and 3 months after vaccination
Nasopharyngeal carriage of pneumococcus
Proportion of participants with nasopharyngeal carriage of Pneumosil vaccine-type pneumococci and their antimicrobial resistance patterns
Measured: 3 months after vaccination
Severe acute malnutrition recovery
Weight-for-height/length z-score >= -2 or MUAC >12.5cm
Measured: Reviewed at all study visits until completion (12 months after vaccination)
Re-hospitalisation
Any repeat admission to hospital as confirmed by medical records
Measured: 3 months and 12 months after vaccination
Mortality
Deaths as reported. Cause of death determined from review of medial records.
Measured: 3 and 12 months after vaccination
Composite illness or mortality
Repeat hospitalisation(s) or death.
Measured: Reviewed at all study visits until completion (12 months after vaccination)
Salmonella Typhi antibodies
Proportion of paticipants with >4 fold rise (compared to pre-vaccination) of Salmonella Typhi anti-Vi IgG geometric mean titres (GMTs)
Measured: 4 weeks and 3 months after vaccination for all participants, plus 4 months and 6 months after vaccination for participants in the control arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start16 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Malnutrition in ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, single-centre, double-blind, phase 4, randomised, controlled trial in children aged 6-59 months hospitalised with severe acute malnutrition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nick Fancourt
- Sponsor type
- University, hospital or other
- Collaborators
- Murdoch Childrens Research Institute, The University of Western Australia, University of Edinburgh, Timor-Leste Ministry of Health
- Responsible party
- Sponsor-investigator, Nick Fancourt, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817421
- Sponsor's protocol ID
- MENTL2024-4996
- Other IDs
- U1111-1312-6848
- Acronym
- OPTIMAL
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan for IPD sharing is in development.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06817421
- Acronym / sponsor ID
- OPTIMAL / MENTL2024-4996
- Conditions
- Severe Acute Malnutrition in Childhood, Pneumococcal Disease, Pneumococcal Vaccines, Pneumococcal Infection, Pneumonia in Children
- Keywords
- Pneumococcal, Severe Acute Malnutrition in childhood, Pneumococcal vaccine, Pneumosil, Pneumococcal disease, Pneumococcal infection, Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Nick FancourtUniversity, hospital or other
- Collaborators
- Murdoch Childrens Research Institute, The University of Western Australia, University of Edinburgh, Timor-Leste Ministry of Health
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-centre, double-blind, randomised controlled trial in 264 children aged 6-59 months hospitalised with severe acute malnutrition.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, single-centre, double-blind, phase 4, randomised, controlled trial in children aged 6-59 months hospitalised with severe acute malnutrition.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm: Pneumosil | Experimental | Biological: Pneumococcal conjugate vaccine |
| Control Arm: Typbar TCV | Other | Biological: Typhoid conjugate vaccine |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 6-59 months at the time of hospitalisation
- Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c):
- Parent/carer is willing for their child to participate in the study and has provided written informed consent
- Parent/carer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study
Key exclusion criteria (6 listed)
- Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.
- Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.
- Suspected primary or secondary immunodeficiency or prolonged administration (>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.
- Known terminal illness expected to result in death within 6 months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal conjugate vaccine10-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 | Treatment Arm: Pneumosil |
| Typhoid conjugate vaccineTyphoid 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. | Biological | Control Arm: Typbar TCV |
Primary outcome
Serotype-specific immunoglobulin G (IgG) antibodies
Time frame: 4 weeks after vaccination
Pneumosil serotype-specific (1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 23F) immunoglobulin G (IgG) geometric mean concentrations (GMCs).
12 secondary outcomes
Serotype-specific IgG antibodies
Time frame: 4 weeks and 3 months after vaccination
Proportion of participants with serotype-specific IgG antibody responses ≥ 0.35 μg/mL
Time frame: 4 weeks and 3 months after vaccination
Functional antibody responses
Time frame: 4 weeks and 3 months after vaccination
Functional antibody responses
Time frame: 4 weeks and 3 months after vaccination
Salivary IgG antibodies
Time frame: 4 weeks and 3 months after vaccination
Salivary immunoglobulin A (IgA) antibodies
Time frame: 4 weeks and 3 months after vaccination
Nasopharyngeal carriage of pneumococcus
Time frame: 3 months after vaccination
Severe acute malnutrition recovery
Time frame: Reviewed at all study visits until completion (12 months after vaccination)
Re-hospitalisation
Time frame: 3 months and 12 months after vaccination
Mortality
Time frame: 3 and 12 months after vaccination
Composite illness or mortality
Time frame: Reviewed at all study visits until completion (12 months after vaccination)
Salmonella Typhi antibodies
Time frame: 4 weeks and 3 months after vaccination for all participants, plus 4 months and 6 months after vaccination for participants in the control arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Pneumosil product informationLink provided by the sponsor.
- Typbar-TCV product informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Plan for IPD sharing is in development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pneumococcal conjugate vaccine and Typhoid conjugate vaccine in people with Severe Acute Malnutrition in Childhood and Pneumococcal Disease, run by Nick Fancourt at 1 site in Timor-Leste.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Timor-Leste. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas S. S. Fancourt, PhD (+61889468600, nick.fancourt@menzies.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotype-specific immunoglobulin G (IgG) antibodies (time frame: 4 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.