Modified measles vaccination schedule to prevent allergies and infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.