Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children
Recruiting · NCT05758532 · Interventional (participants receive a specific treatment) · Lead sponsor: Laure Pittet, MD-PhD
View the official record on ClinicalTrials.gov →Interventions studied
Measles-Mumps-Rubella vaccine (MMR)
What this trial is about
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
Who can take part
Age range
6 Months to 6 Months
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
- Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
- 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)
- 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 it is running
1 location listed.
- University Hospitals of Geneva - Geneva, Switzerland