MMR-3 research; The effect of a third vaccination with the mumps, measles and rubella combination vaccine on the immunity against the mumps virus in healthy young adults.

Phase 1

• Conditions: immunological response to an extra mumps immunization (in healthy volunteers); Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-001104-36-NL
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-23
• Study Completion: 2020-03-25
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

Healthy young adult 18-25 years of age.
Previously been immunized with two doses of the MMR vaccine according to the Dutch NIP (MMR-1 at ~14 months and MMR-2 at ~9 years).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical conditions that will severely affect immunological responses to vaccinations, such as, but not limited to, cancer or an immune disorder.
Vaccination should be postponed during any illness with fever >38.5°C until the fever has disappeared.
Vaccination with any vaccine during the first two weeks before and four weeks after MMR-3.
An additional MMR vaccination during the study.
Coagulation disorder and/or anticoagulant medication.
Be or have been under immunosuppressive medical treatment, like cytostatics, high-dose corticosteroids, immune globulins, blood or plasma transfusions that might interfere with the results of the study (within the previous 3 months).
Have or previously had clinical symptoms of mumps virus infection.
Have or previously had cases of mumps disease within your Household.
Had experienced a previous severe adverse reaction to any vaccine.
Being pregnant; Furthermore, pregnancy should be avoided for 1 month following vaccination.
Breast-feeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified