NCT05758532 Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children
| NCT ID | NCT05758532 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Laure Pittet, MD-PhD |
| Condition | Respiratory Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2026-04 |
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 500 participants in total. It began in 2023-03-17 with a primary completion date of 2026-04.
⚠ 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
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
Eligibility Criteria
Inclusion Criteria: 1. Informed Consent as documented by signature 2. 6-month-old children 3. In overall good health, without any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) and no clinically significant abnormal finding on history and/or physical examination 4. Fully immunised for age according to the Swiss vaccination schedule 1. with at least 2 doses of DTP-containing vaccine 2. the last dose of vaccine received at least 2 weeks prior to enrolment Exclusion Criteria: 1. Contra-indications to MMR, including 1. immunosuppression (i.e. proven, suspected, or planned) 2. allergy to a component of the vaccine 3. receipt of a live-attenuated vaccine in the four weeks prior to inclusion 2. Vaccine refusal 3. Indication for an early MMR vaccination, including 1. Measles outbreak 2. Planned immunosuppression (indication to an accelerated schedule to be completed before starting an immunosuppressive treatment) 3. Travel to a region with a high risk of measles outbreak 4. Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including 1. severe eczema 2. parental will 5. Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc. 6. Plan to move out of the country or have prolong absence during the trial 7. Other sibling included in the trial (in the case of multiple pregnancy, only one child can be randomised) 8. Any temporary contra-indication to MMR, including child being sick (active significant illness, inclusion can be delayed a few days until the illness resolves)
Contact & Investigator
Laure F Pittet, MD-PhD
PRINCIPAL INVESTIGATOR
University Hospitals of Geneva
Frequently Asked Questions
Who can join the NCT05758532 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 6 Months, studying Respiratory Tract Infections. 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 NCT05758532 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 NCT05758532 currently recruiting?
Yes, NCT05758532 is actively recruiting participants. Contact the research team at laure.pittet@hcuge.ch for enrollment information.
Where is the NCT05758532 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT05758532 clinical trial?
NCT05758532 is sponsored by Laure Pittet, MD-PhD. The principal investigator is Laure F Pittet, MD-PhD at University Hospitals of Geneva. The trial plans to enroll 500 participants.