RecruitingPhase 4NCT05758532

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

Sponsor

Laure Pittet, MD-PhD

Enrollment

500 participants

Start Date

Mar 17, 2023

Study Type

INTERVENTIONAL

Conditions

Infections Allergy Eczema Respiratory Tract Infections

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

Min Age: 6 MonthsMax Age: 6 Months

Inclusion Criteria6

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 Criteria16

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)