Immunological effect of early extra MMR immunizatio
- Conditions
- healthy volunteer(immunological response to early extra measles immunization)Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2013-003078-28-NL
- Lead Sponsor
- RIVM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of an early extra measles immunization between 6 and 12 months of age on the development of humoral and cell-mediated immunity against measles following routine MMR immunization at 14 months of age.;Secondary Objective: Determine effect of early extra measles immunization on the immunogenicity against other infant vaccines of the NIP <br><br>Determine the influence of maternal measles antibodies on the infants’ immune response to measles immunization<br><br>Determine the rate of measles (neutralizing) antibody decline between 6 weeks and 1 year after routine MMR immunization at 14 months of age<br>;Primary end point(s): Measles specific B- and T-cell immunogenicity <br><br>Measles specific serum IgG antibody concentrations, avidity (Luminex), and functional antibody characteristics with plaque neutralisation (PRN);Timepoint(s) of evaluation of this end point: immediately before and 7-9 days, 6 weeks and one year post MMR-1
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Serum IgG antibody concentrations against other vaccines of the NIP (mumps, rubella, MenC, diphtheria, tetanus, pertussis antigens (Ptx, FHA and PRN), Hib, HepB, and pneumococcal serotypes present in PCV10 (Luminex)<br><br>Measles, mumps and rubella antibody concentrations in DBS collected at 6 days of age, to monitor the concentrations of maternal antibodies delivered at birth (and to predict the concentrations at the time of MMR-0)<br>;Timepoint(s) of evaluation of this end point: immediately before and 7-9 days, 6 weeks and one year post MMR-1