Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children

NCT05758532 | Recruiting Phase 4 DMC

• 4 other identifiers: 2022-00616Ambizione n° PZ00P3_209050STARTER-MD n° RS08-08PRD n° 4-2022-I
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Tract Infections; Infections; Allergy; Eczema

Keywords

Non-specific/off-target effect of vaccine

Outcome Measures

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.

  Measured over the 3 months following randomisation

Secondary Outcomes (17)

• Infection: Time to first infection within the 3 months following randomisation

  Measured over the 3 months following randomisation

• Infection: Time to first infection within the 18 months following randomisation

  Measured over the 18 months following randomisation

• Infection: Prevalence of infection within the 3 months following randomisation

  Measured over the 3 months following randomisation

• Infection: Prevalence of infection within the 18 months following randomisation

  Measured over the 18 months following randomisation

• Infection: Incidence of infection within the 3 months following randomisation

  Measured over the 3 months following randomisation

Other Outcomes (16)

• Allergic/atopic diseases: time to first allergic/atopic disease flare within the 3 months following randomisation

  Measured over the 3 months following randomisation

• Allergic/atopic diseases: time to first allergic/atopic disease flare within the 18 months following randomisation

  Measured over the 18 months following randomisation

• Allergic/atopic diseases: Prevalence of allergic/atopic disease within the 3 months following randomisation

  Measured over the 3 months following randomisation

Study Arms (4)

C.C. : Both MMR doses given on current schedule (9 months and 12 months)

ACTIVE COMPARATOR

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)

Biological: Measles-Mumps-Rubella vaccine (MMR)

M.C. : 1st MMR on modified schedule (6 months) and 2nd MMR on current schedule (12 months)

EXPERIMENTAL

Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at: * 6 months (= modified schedule) * 12 months, concomitant with other vaccines (= current Swiss schedule)

Biological: Measles-Mumps-Rubella vaccine (MMR)

C. M. : 1st MMR on current schedule (9 months) and 2nd MMR on modified schedule (13 months)

EXPERIMENTAL

Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at: * 9 months (= current Swiss schedule) * 13 months, distant from other vaccines (= modified schedule)

Biological: Measles-Mumps-Rubella vaccine (MMR)

M.M. : Both MMR doses given on modified schedule (6 months and 13 months)

EXPERIMENTAL

Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at: * 6 months (= modified schedule) * 13 months, distant from other vaccines (= modified schedule)

Biological: Measles-Mumps-Rubella vaccine (MMR)

Interventions

Measles-Mumps-Rubella vaccine (MMR) BIOLOGICAL

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); C.C. : Both MMR doses given on current schedule (9 months and 12 months); M.C. : 1st MMR on modified schedule (6 months) and 2nd MMR on current schedule (12 months); M.M. : Both MMR doses given on modified schedule (6 months and 13 months)

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed Consent as documented by signature
• 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

You may not qualify if:

• Contra-indications to MMR, including
• immunosuppression (i.e. proven, suspected, or planned)
• allergy to a component of the vaccine
• 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)

Sponsors & Collaborators

• Laure Pittet, MD-PhD: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Infections; Hypersensitivity; Eczema

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Laure F Pittet, MD-PhD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure F Pittet, MD-PhD

CONTACT

+41 22 372 33 11; laure.pittet@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Scientist

Model Details: Phase IV, single-centre, 4-group, open-label, randomised controlled trial with a factorial design (primary outcome analysed as a 2-group trial)

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 7, 2023
• Study Start: March 17, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After database lock, a 12-month embargo period will be in place, to allow adequate time for analyses and publication outputs. Data transfer to a FAIR plateform will occur during the embargo period.
• Access Criteria: Researchers from a recognised research institution can approach the PI for access of data. The researcher will need to provide evidence that the proposed use of the data has been ethically reviewed and approved by an Institutional Review Board (IRB)/ Human Research Ethics Committee(HREC), and accept HUG's conditions, under a collaborator agreement.

Locations

CH (1)