Immunological effect of early extra MMR immunization in infants between 6 and 12 months of age in an outbreak setting
Phase 4
Completed
- Conditions
- Measles infectionparamyxovirus10047438
- Registration Number
- NL-OMON44694
- Lead Sponsor
- RIVM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Group 1: infants receiving (or having received) MMR-0 between 6-12 months of age and who are about to receive the MMR-1 at 14 months of age;Group 2: infants not receiving MMR-0 and who are about to receive the MMR-1 at 14 months of age
Exclusion Criteria
Encountered measles infection earlier in life;Receiving immunosuppressive medication;Presence of a serious disease that requires medical care that can interfere with the results of the study;Known or expected allergy/hypersensitivity against one of the vaccine ingredients;Known or suspected immunological disorder;Bleeding disorders
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measles specific B- and T-cell immunogenicity<br /><br><br /><br>Measles specific serum IgG antibody concentrations, avidity (Luminex),<br /><br>and functional antibody characteristics with plaque neutralisation (PRN)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Serum IgG antibody concentrations against other vaccines of the NIP<br /><br>(mumps, rubella, MenC, diphtheria, tetanus, pertussis antigens (Ptx, FHA<br /><br>and PRN), Hib, HepB, and pneumococcal serotypes present in PCV10<br /><br>(Luminex)<br /><br><br /><br>Measles, mumps and rubella antibody concentrations in DBS collected at<br /><br>6 days of age, to monitor the concentrations of maternal antibodies<br /><br>delivered at birth (and to predict the concentrations at the time of MMR-<br /><br>0)</p><br>