Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-6
SponsorLaure Pittet, MD-PhD
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Measles-Mumps-Rubella vaccine (MMR)
Biological/Vaccine0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: C.C. : Both MMR doses given on current schedule (9 months and 12 months)Active comparator 1 intervention
Group B: M.C. : 1st MMR on modified schedule (6 months) and 2nd MMR on current schedule (12 months)Experimental treatment 1 intervention
Group C: C. M. : 1st MMR on current schedule (9 months) and 2nd MMR on modified schedule (13 months)Experimental treatment 1 intervention
Group D: M.M. : Both MMR doses given on modified schedule (6 months and 13 months)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of respiratory infection within the 3 months following randomisation
Incidence of parent-reported respiratory infections between 6 months and 9 months of age using fortnightly REDCap questionnaires, with validation of data by confirmation with treating paediatrician and medical records.
Time frame
Measured over the 3 months following randomisationSecondary outcomes
1
Infection: Time to first infection within the 3 months following randomisation
Calculated as: For participants who have an event: Date of event onset - date of randomisation For participants who did not have an event: Earliest censoring date - date of randomisation
Time frame
Measured over the 3 months following randomisation2
Infection: Time to first infection within the 18 months following randomisation
Calculated as: For participants who have an event: Date of event onset - date of randomisation For participants who did not have an event: Earliest censoring date - date of randomisation
Time frame
Measured over the 18 months following randomisation3
Infection: Prevalence of infection within the 3 months following randomisation
Calculated as: number of participants who have an event / total number of participants
Time frame
Measured over the 3 months following randomisation4
Infection: Prevalence of infection within the 18 months following randomisation
Calculated as: number of participants who have an event / total number of participants
Time frame
Measured over the 18 months following randomisationOther outcomes
1
Allergic/atopic diseases: time to first allergic/atopic disease flare within the 3 months following randomisation
Calculated as: For participants who have a flare: Date of event onset - date of randomisation For participants who did not have a flare: Earliest censoring date - date of randomisation
Time frame
Measured over the 3 months following randomisation2
Allergic/atopic diseases: time to first allergic/atopic disease flare within the 18 months following randomisation
Calculated as: For participants who have a flare: Date of event onset - date of randomisation For participants who did not have a flare: Earliest censoring date - date of randomisation
Time frame
Measured over the 18 months following randomisation3
Allergic/atopic diseases: Prevalence of allergic/atopic disease within the 3 months following randomisation
Calculated as: number of participants who have a flare / total number of participants
Time frame
Measured over the 3 months following randomisation4
Allergic/atopic diseases: Prevalence of allergic/atopic disease within the 18 months following randomisation
Calculated as: number of participants who have a flare / total number of participants
Time frame
Measured over the 18 months following randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laure Pittet, MD-PhD
Lead sponsor
Pediatric Clinical Research Platform
Sponsor institution
Source ClinicalTrials.gov