Respiratory Tract InfectionsPhase 4NEMAUNCT05758532
Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children
A Phase 4 study testing Measles-Mumps-Rubella vaccine (MMR) in people with Respiratory Tract Infections and Infections, run by Laure Pittet, MD-PhD at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Infections, Allergy
- What is being tested?
- Measles-Mumps-Rubella vaccine (MMR)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2023to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals of Geneva
Geneva, 1211
Laure F Pittet, MD-PhD
Laure F Pittet, MD-PhD
About this study
Official title: 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
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
Read the detailed description
The overall objective of this project is to assess, in a randomised control trial (RCT), the effects of a "modified" MMR schedule in children, by an in-depth characterisation of both the clinical effects and the underlying immunomodulatory changes.
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
- Respiratory Tract Infections, Infections, Allergy, Eczema
- Being tested
- Measles-Mumps-Rubella vaccine (MMR)
- Keywords
- Non-specific/off-target effect of vaccine
- Medical subject headings
- Respiratory Tract Infections, Infections, Hypersensitivity, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Biological: Measles-Mumps-Rubella vaccine (MMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured over the 3 months following randomisation
Secondary outcomes (17)
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
Measured: Measured over the 3 months following randomisation
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
Measured: Measured over the 18 months following randomisation
Infection: Prevalence of infection within the 3 months following randomisation
Calculated as:
number of participants who have an event / total number of participants
Measured: Measured over the 3 months following randomisation
Infection: Prevalence of infection within the 18 months following randomisation
Calculated as:
number of participants who have an event / total number of participants
Measured: Measured over the 18 months following randomisation
Infection: Incidence of infection within the 3 months following randomisation
Calculated as:
number of events / total time of follow-up
Measured: Measured over the 3 months following randomisation
Infection: Incidence of infection within the 18 months following randomisation
Calculated as:
number of events / total time of follow-up
Measured: Measured over the 18 months following randomisation
Infection: Number of days free of infection within the 3 months following randomisation
Calculated as:
number of days free of event / total days of follow-up of participants
Measured: Measured over the 3 months following randomisation
Infection: Number of days free of infection within the 18 months following randomisation
Calculated as:
number of days free of event / total days of follow-up of participants
Measured: Measured over the 18 months following randomisation
Infection severity: Duration of infection within the 3 months following randomisation
Per event, calculated as: date of recovery - date of onset
Measured: Measured over the 3 months following randomisation
Infection severity: Duration of infection within the 18 months following randomisation
Per event, calculated as: date of recovery - date of onset
Measured: Measured over the 18 months following randomisation
Infection severity: Antibiotic use for infection within the 3 months following randomisation
Per event, defined as a binary variable (yes/no)
Measured: Measured over the 3 months following randomisation
Infection severity: Antibiotic use for infection within the 18 months following randomisation
Per event, defined as a binary variable (yes/no)
Measured: Measured over the 18 months following randomisation
Infection severity: Hospitalisation for infection within the 3 months following randomisation
Per event, defined as a binary variable (yes/no)
Measured: Measured over the 3 months following randomisation
Infection severity: Hospitalisation for infection within the 18 months following randomisation
Per event, defined as a binary variable (yes/no)
Measured: Measured over the 18 months following randomisation
Infection severity: Outcome of infection within the 3 months following randomisation
Per event, defined as a categorical variable (uneventful/complication or sequel/death)
Measured: Measured over the 3 months following randomisation
Infection severity: Outcome of infection within the 18 months following randomisation
Per event, defined as a categorical variable (uneventful/complication or sequel/death)
Measured: Measured over the 18 months following randomisation
Incidence of respiratory infection within the 18 months following randomisation
Incidence of parent-reported respiratory infections between 6 months and 24 months of age using fortnightly REDCap questionnaires, with validation of data by confirmation with treating paediatrician and medical records.
Measured: Measured over the 18 months following randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start17 Mar 2023
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Phase IV, single-centre, 4-group, open-label, randomised controlled trial with a factorial design (primary outcome analysed as a 2-group trial)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laure Pittet, MD-PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laure Pittet, MD-PhD, Pediatric Clinical Research Platform
- Investigators
- Laure F Pittet, MD-PhD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758532
- Sponsor's protocol ID
- 2022-00616
- Other IDs
- Ambizione n° PZ00P3_209050, STARTER-MD n° RS08-08, PRD n° 4-2022-I
- Acronym
- NEMAU
- Status last verified
- May 2024
- First submitted
- 10 Feb 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under the terms of the funding agreement with the Swiss National Science Foundation, the NEMAU trial has a data sharing agreement in place. An anonymised Individual Participant Data (IPD) dataset and a data dictionary will be provided to a FAIR platform after database lock.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05758532
- Acronym / sponsor ID
- NEMAU / 2022-00616
- Conditions
- Respiratory Tract Infections, Infections, Allergy, Eczema
- Keywords
- Non-specific/off-target effect of vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Laure Pittet, MD-PhDUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
Detailed description
The overall objective of this project is to assess, in a randomised control trial (RCT), the effects of a "modified" MMR schedule in children, by an in-depth characterisation of both the clinical effects and the underlying immunomodulatory changes.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase IV, single-centre, 4-group, open-label, randomised controlled trial with a factorial design (primary outcome analysed as a 2-group trial)
| Arm | Type | Receives |
|---|---|---|
| C.C. : Both MMR doses given on current schedule (9 months and 12 months) | Active comparator | Biological: Measles-Mumps-Rubella vaccine (MMR)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) |
| M.C. : 1st MMR on modified schedule (6 months) and 2nd MMR on current schedule (12 months) | Experimental | Biological: Measles-Mumps-Rubella vaccine (MMR)Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at: * 6 months (= modified schedule) * 12 months, concomitant with other vaccines (= current Swiss schedule) |
| C. M. : 1st MMR on current schedule (9 months) and 2nd MMR on modified schedule (13 months) | Experimental | Biological: Measles-Mumps-Rubella vaccine (MMR)Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at: * 9 months (= current Swiss schedule) * 13 months, distant from other vaccines (= modified schedule) |
| M.M. : Both MMR doses given on modified schedule (6 months and 13 months) | Experimental | Biological: Measles-Mumps-Rubella vaccine (MMR)Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at: * 6 months (= modified schedule) * 13 months, distant from other vaccines (= modified schedule) |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Contra-indications to MMR, including
- Vaccine refusal
- Indication for an early MMR vaccination, including
- Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including
- Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | 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) |
Primary outcome
Incidence of respiratory infection within the 3 months following randomisation
Time frame: Measured over 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.
17 secondary outcomes
Infection: Time to first infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection: Time to first infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection: Prevalence of infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection: Prevalence of infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection: Incidence of infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection: Incidence of infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection: Number of days free of infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection: Number of days free of infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection severity: Duration of infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection severity: Duration of infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection severity: Antibiotic use for infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection severity: Antibiotic use for infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection severity: Hospitalisation for infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection severity: Hospitalisation for infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Infection severity: Outcome of infection within the 3 months following randomisation
Time frame: Measured over the 3 months following randomisation
Infection severity: Outcome of infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Incidence of respiratory infection within the 18 months following randomisation
Time frame: Measured over the 18 months following randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Yes. Under the terms of the funding agreement with the Swiss National Science Foundation, the NEMAU trial has a data sharing agreement in place. An anonymised Individual Participant Data (IPD) dataset and a data dictionary will be provided to a FAIR platform after database lock.
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laure F Pittet, MD-PhD principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measles-Mumps-Rubella vaccine (MMR) in people with Respiratory Tract Infections and Infections, run by Laure Pittet, MD-PhD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure F Pittet, MD-PhD (+41 22 372 33 11, laure.pittet@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory infection within the 3 months following randomisation (time frame: Measured over the 3 months following randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.