NCT05758532RecruitingPhase 4
Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection 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
Source: ClinicalTrials.gov · Last updated 29 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 17 Mar 2023
- Primary completion date
- Apr 2026
- Lead sponsor
- Laure Pittet, MD-PhD
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05758532
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 500
- From 17 Mar 2023 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contra-indications to MMR, including
- immunosuppression (i.e. proven, suspected, or planned)
- allergy to a component of the vaccine
- receipt of a live-attenuated vaccine in the four weeks prior to inclusion
- Vaccine refusal
Other illness
- Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
- Any temporary contra-indication to MMR, including child being sick (active significant illness, inclusion can be delayed a few days until the illness resolves)
Other
- Indication for an early MMR vaccination, including
- Measles outbreak
- Planned immunosuppression (indication to an accelerated schedule to be completed before starting an immunosuppressive treatment)
- Travel to a region with a high risk of measles outbreak
- Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including
- severe eczema
- parental will
- Plan to move out of the country or have prolong absence during the trial
- Other sibling included in the trial (in the case of multiple pregnancy, only one child can be randomised)
Who the study is looking for
- Informed Consent as documented by signature
- 6-month-old children
- 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
- Fully immunised for age according to the Swiss vaccination schedule
- with at least 2 doses of DTP-containing vaccine
- the last dose of vaccine received at least 2 weeks prior to enrolment
Age in the registry: 6 months to 6 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.