Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children
NCT ID: NCT05758532
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2023-03-17
2026-12-31
Brief Summary
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Detailed Description
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The current Swiss administration schedule of giving MMR at 9 and 12 months of age ("current schedule") will be compared with a "modified schedule". This is expected to maximise the beneficial non-specific effects of MMR by giving it at 6 and 13 months of age, separately from other vaccines ("modified schedule"). Factorial analysis will enable assessment of the benefit of the intervention on each of the two doses of MMR separately or in combination.
The clinical aims are to determine whether a modified schedule of MMR administration reduces both the risk and severity of: (i) infections with unrelated pathogens and (ii) atopic and allergic diseases.
The laboratory aims are to: (i) quantify and characterise the immunological non-specific effects of MMR, and (ii) identify the biological pathways and molecular mechanisms that are altered by MMR vaccination.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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C.C. : Both MMR doses given on current schedule (9 months and 12 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
* 9 months (= current Swiss schedule)
* 12 months, concomitant with other vaccines (= current Swiss schedule)
Measles-Mumps-Rubella vaccine (MMR)
0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh
M.C. : 1st MMR on modified schedule (6 months) and 2nd MMR on current schedule (12 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
* 6 months (= modified schedule)
* 12 months, concomitant with other vaccines (= current Swiss schedule)
Measles-Mumps-Rubella vaccine (MMR)
0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh
C. M. : 1st MMR on current schedule (9 months) and 2nd MMR on modified schedule (13 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
* 9 months (= current Swiss schedule)
* 13 months, distant from other vaccines (= modified schedule)
Measles-Mumps-Rubella vaccine (MMR)
0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh
M.M. : Both MMR doses given on modified schedule (6 months and 13 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
* 6 months (= modified schedule)
* 13 months, distant from other vaccines (= modified schedule)
Measles-Mumps-Rubella vaccine (MMR)
0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh
Interventions
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Measles-Mumps-Rubella vaccine (MMR)
0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh
Eligibility Criteria
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Inclusion Criteria
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. 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)
6 Months
6 Months
ALL
Yes
Sponsors
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Laure Pittet, MD-PhD
OTHER
Responsible Party
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Laure Pittet, MD-PhD
Clinical Scientist
Principal Investigators
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Laure F Pittet, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Geneva
Locations
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University Hospitals of Geneva
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Laure F Pittet, MD-PhD
Role: primary
Other Identifiers
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Ambizione n° PZ00P3_209050
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STARTER-MD n° RS08-08
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRD n° 4-2022-I
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022-00616
Identifier Type: -
Identifier Source: org_study_id
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