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

Phase 4

Completed

• Conditions: Mumps infection; parotitis; 10047438

• Registration Number: NL-OMON47906
• Lead Sponsor: RIVM

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-03-25
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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