NCT06068530 Mass Vaccine and Drug Administration, Bangladesh
| NCT ID | NCT06068530 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Oxford |
| Condition | Plasmodium Falciparum Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 10,000 participants in total. It began in 2025-02-15 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.
Eligibility Criteria
Inclusion Criteria: * Current residence in a study village irrespective of permanence * Age 6 months and above (no upper age limit) * Written informed consent provided by participants (or a parent/guardian in case the participant is under 18 years old) Exclusion Criteria: * Pregnancy, plan to get pregnant, or breastfeeding. * Acute illness requiring intervention * A history of an adverse reaction to study drugs/vaccine and prior receipt of any other malaria vaccine or enrolment in another intervention trial.
Contact & Investigator
Lorenz von Seidlein
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT06068530 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Plasmodium Falciparum Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06068530 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06068530 currently recruiting?
Yes, NCT06068530 is actively recruiting participants. Contact the research team at Lorenz@tropmedres.ac for enrollment information.
Where is the NCT06068530 trial being conducted?
This trial is being conducted at Bāndarban, Bangladesh, Lāma, Bangladesh.
Who is sponsoring the NCT06068530 clinical trial?
NCT06068530 is sponsored by University of Oxford. The principal investigator is Lorenz von Seidlein at Mahidol University. The trial plans to enroll 10,000 participants.