Meales-mumps-rubella VaccinePhase 4NCT03780179

MMR at 6 Months Trial

A Phase 4 study testing MMRvaxpro in people with Meales-mumps-rubella Vaccine, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age Read more about this study

Who is it for?: Ages 5 to 7 months
Conditions the study is for: Meales-mumps-rubella Vaccine
What is being tested?: MMRvaxpro
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6,540 participants
Where: 2 sitesDenmark
Study dates: 15 Apr 2019to 7 Jan 2022
Phase: Phase 4
Are there results?: None posted in the registry

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 5 to 7 months
All sexes
No healthy volunteers
Child

Who may be able to join

Gestational age of 32+ weeks.
Birth weight of 1000+ grams.
Signed informed consent from the parents.

Who cannot join

Immune-deficiency (primary or acquired) or -suppression.
Intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy).
Signs of severe illness or major malformation.
No Danish-speaking parent.
Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded.
Children with known fructose intolerance, thrombocytopenia or any coagulation disorder will be excluded.

Show all 9Show fewer

Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded.
Further, children are excluded from the trial if any contraindication is suspected: history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin.
Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems will be excluded.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

Rigshospitalet
Copenhagen, Copenhagen Ø, 2100
Herlev Hospital
Herlev, 2730

Other trials in Denmark

About this study

Official title: Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting

Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age

Conditions: Meales-mumps-rubella Vaccine
Being tested: MMRvaxpro, Placebo
Keywords: measles-mumps-rubella vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MMRvaxproBiological
MMRvaxpro vaccine
PlaceboBiological
Placebo

Study groups in NCT03780179
Study group	Role	What they receive
MMRvaxpro	Experimental	Not described Receives: Biological: MMRvaxpro
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Humoral immunogenicity
The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be >120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme.
Measured: 1 months after intervention
Hospitalisation for infection
Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts.
Measured: 6-12 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 20197 Jan 2022

First posted19 Dec 2018
Study start15 Apr 2019
Primary completion7 Jan 2022
Study completion7 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Meales-mumps-rubella VaccineStudies of the same condition, open and under way.
More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
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: Parallel groups
Model description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 6,540 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03780179
Sponsor's protocol ID: LGS.MMR.01.2016.2022
Status last verified: Jan 2022
First submitted: 17 Dec 2018
Last updated: 13 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Buus S, Vittrup DM, Schmidt JD, Jensen A, Stryhn A, Stensballe LG. Measles-mumps-rubella-vaccination at 6 months of age induces measles-specific T cell responses: a randomized controlled trial. Front Immunol. 2025 Mar 17;16:1546253. doi: 10.3389/fimmu.2025.1546253. eCollection 2025.
PubMed 40165977
Sorensen JK, Jensen A, Zimakoff AC, Vittrup DM, Malon M, Kim S, Hatley EV, Bybjerg-Grauholm J, Kaur S, Pociot F, Stensballe LG, Svensson J. Genetic associations with measles PRNT and IgG antibody response to MMR vaccination in 6- and 15-month-old children. Vaccine. 2025 Mar 19;50:126788. doi: 10.1016/j.vaccine.2025.126788. Epub 2025 Feb 5.
PubMed 39914254
Vittrup DM, Jensen A, Sorensen JK, Zimakoff AC, Malon M, Charabi S, Johansen MR, Simoes EAF, Kirkby NS, Buus S, Svensson J, Stensballe LG. Immunogenicity and reactogenicity following MMR vaccination in 5-7-month-old infants: a double-blind placebo-controlled randomized clinical trial in 6540 Danish infants. EClinicalMedicine. 2024 Jan 12;68:102421. doi: 10.1016/j.eclinm.2023.102421. eCollection 2024 Feb.
PubMed 38292039
Zimakoff AC, Jensen A, Vittrup DM, Herlufsen EH, Sorensen JK, Malon M, Svensson J, Stensballe LG. Measles, mumps, and rubella vaccine at age 6 months and hospitalisation for infection before age 12 months: randomised controlled trial. BMJ. 2023 Jun 7;381:e072724. doi: 10.1136/bmj-2022-072724.
PubMed 37286215

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting
ClinicalTrials.gov ID: NCT03780179
Acronym / sponsor ID: LGS.MMR.01.2016.2022
Conditions: Meales-mumps-rubella Vaccine
Keywords: measles-mumps-rubella vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,540 participants (actual)
Lead sponsor: Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
Study start: 15 Apr 2019 (actual)
Primary completion: 7 Jan 2022 (actual)
Study completion: 7 Jan 2022 (actual)
First posted: 19 Dec 2018 (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.

Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)

Arm	Type	Receives
MMRvaxpro	Experimental	Biological: MMRvaxpro
Placebo	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 5 to 7 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Gestational age of 32+ weeks.
Birth weight of 1000+ grams.
Signed informed consent from the parents.

Key exclusion criteria (9 listed)

Immune-deficiency (primary or acquired) or -suppression.
Intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy).
Signs of severe illness or major malformation.
No Danish-speaking parent.
Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded.

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
MMRvaxproMMRvaxpro vaccine	Biological	MMRvaxpro
PlaceboPlacebo	Biological	Placebo

Primary outcome

Humoral immunogenicity
Time frame: 1 months after intervention
The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be >120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme.
Hospitalisation for infection
Time frame: 6-12 months of age
Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
Derived from this study: PubMed 40165977Buus S, Vittrup DM, Schmidt JD, Jensen A, Stryhn A, Stensballe LG. Measles-mumps-rubella-vaccination at 6 months of age induces measles-specific T cell responses: a randomized controlled trial. Front Immunol. 2025 Mar 17;16:1546253. doi: 10.3389/fimmu.2025.1546253. eCollection 2025.
Derived from this study: PubMed 39914254Sorensen JK, Jensen A, Zimakoff AC, Vittrup DM, Malon M, Kim S, Hatley EV, Bybjerg-Grauholm J, Kaur S, Pociot F, Stensballe LG, Svensson J. Genetic associations with measles PRNT and IgG antibody response to MMR vaccination in 6- and 15-month-old children. Vaccine. 2025 Mar 19;50:126788. doi: 10.1016/j.vaccine.2025.126788. Epub 2025 Feb 5.
Derived from this study: PubMed 38292039Vittrup DM, Jensen A, Sorensen JK, Zimakoff AC, Malon M, Charabi S, Johansen MR, Simoes EAF, Kirkby NS, Buus S, Svensson J, Stensballe LG. Immunogenicity and reactogenicity following MMR vaccination in 5-7-month-old infants: a double-blind placebo-controlled randomized clinical trial in 6540 Danish infants. EClinicalMedicine. 2024 Jan 12;68:102421. doi: 10.1016/j.eclinm.2023.102421. eCollection 2024 Feb.
Derived from this study: PubMed 37286215Zimakoff AC, Jensen A, Vittrup DM, Herlufsen EH, Sorensen JK, Malon M, Svensson J, Stensballe LG. Measles, mumps, and rubella vaccine at age 6 months and hospitalisation for infection before age 12 months: randomised controlled trial. BMJ. 2023 Jun 7;381:e072724. doi: 10.1136/bmj-2022-072724.

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MMRvaxpro in people with Meales-mumps-rubella Vaccine, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

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 3 inclusion and 9 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: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humoral immunogenicity (time frame: 1 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03780179, which also lists 4 linked publications.

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 13 Jan 2022.