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Immunogenicity and safety study of a third measles mumps rubella (MMR-3) vaccine dose in healthy young adults in The Netherlands

Immunogenicity and safety study of a third measles mumps rubella (MMR-3) vaccine dose in healthy young adults in The Netherlands - Third MMR vaccine dose in young adults (acronym: MMR-3)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47906
Enrollment
150
Registered
2016-05-23
Start date
2016-10-13
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mumps infection parotitis

Interventions

All participants will receive an extra MMR vaccination (intramuscularly) at visit 1.

Sponsors

RIVM
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
* The mumps-specific VN antibody concentrations (against the vaccine and currently circulating mumps virus strains) and IgG antibody concentrations (including antibody avidity) measured in serum samples taken prior to and 10 days, 4 weeks, 1 year and 3 years following a third vaccine dose of MMR

Secondary

MeasureTime frame
* Frequency and intensity of the local and systemic adverse events * Mumps-specific IgA and IgG (saliva) prior to, 4 weeks and 1 year following a third vaccine dose of MMR * The presence and frequency of mumps-specific memory and effector T- and B-cells in peripheral blood following MMR-3, in a voluntary subset of the participants (n=30) prior to, 4 weeks and 1 year following a third vaccine dose of MMR * Serum IgG response against measles and rubella (components of the MMR vaccine) prior to, 10 days, 4 weeks, 1 year and 3 years following a third vaccine dose of MMR

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)