Modified measles vaccination schedule to prevent allergies and infections in children
Harnessing the Beneficial Non-specific Effects of Measles-mumps-rubella Vaccine in Children on Infection With Unrelated Pathogens and Allergic Diseases - a Single-centre Phase IV RCT With a Factorial Design
This study is testing a new timing for the measles vaccine in kids to see if it can help prevent allergies and infections better than the usual schedule.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 6 Months to 6 Months |
| Sex | All |
| Sponsor | Pediatric Clinical Research Platform Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT05758532 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the non-specific effects of the measles-mumps-rubella (MMR) vaccine in children by comparing a modified vaccination schedule with the current Swiss schedule. The modified schedule involves administering the MMR vaccine at 6 and 13 months, separate from other vaccines, to maximize its beneficial effects. The study will assess both the clinical outcomes related to infections and allergies, as well as the underlying immunological changes through a randomized control trial. Factorial analysis will be used to evaluate the effects of each MMR dose individually and in combination.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 6 months who are fully immunized according to the Swiss vaccination schedule.
Not a fit: Patients who may not benefit from this study include those with contraindications to the MMR vaccine or those who have received a live-attenuated vaccine within the last four weeks.
Why it matters
Potential benefit: If successful, this study could lead to a vaccination schedule that reduces the risk and severity of infections and allergic diseases in children.
How similar studies have performed: Other studies have suggested potential benefits of modified vaccination schedules, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Geneva
- University Hospitals of Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Laure F Pittet, MD-PhD — University Hospitals of Geneva
- Study coordinator: Laure F Pittet, MD-PhD
- Email: laure.pittet@hcuge.ch
- Phone: +41 22 372 33 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.