A Phase 4 interventional study of MMR vaccination in Measles, sponsored by Klara M. Pósfay Barbe. Recruiting at 1 site in Switzerland. Open to participants aged 12 Months to 20 Years. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by Klara M. Pósfay Barbe · Phase 4, Interventional, and Prevention
Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed children. Currently, measles vaccine is not recommended in pediatric orthotopic liver transplant recipients, because it is a live-attenuated vaccine.
We want to assess the influence of immunosuppression on immunity against measles in previously vaccinated children and to evaluate the induction of B cell and T cell response against measles elicited by vaccination in children at least 12 months after transplantation.
Eligible children in Group 2 will receive a standard dose (0.5 ml) of MMR vaccine during the first medical visit (V1). The lot number and the expiration date will both be recorded on the patient's case report form (CRF). A serological evaluation 4-8 weeks after MMR will identify children requiring an additional dose given 1-2 months apart, as currently recommended for subjects 1 year-old or with limited immune competence (i.e. HIV-infected children). Serological evaluation 4-8 weeks after the second dose or at the one-year follow-up will identify eventual non-responder requiring a third dose. Three will be the maximal number of administrated dose according to this protocol. The persistence of measles-specific antibodies will be assessed yearly, when patients come for their routine visit to the transplant center.
Children who do not need MMR immunization because of protective levels will be monitored yearly for maintenance of antibody levels during routine yearly visits/ blood samplings and will not have further intervention.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's planned enrollment of 90 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Klara M. Pósfay Barbe is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMR vaccine to seronegative pediatric SOT recipients
Biological: MMR vaccination
Unprotected children will be vaccinated with two MMR vaccines
serologic response to MMR vaccine in seronegative transplant recipients
Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later
Time frame: 2 months after vaccination
Persistance of seroresponse to MMR vaccine
Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients
Time frame: 3 years
Efficacy of MMR vaccine in pediatric SOT recipients
Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients
Time frame: 3 years
Plan to share: No
The record gives a start of Apr 2013, a primary completion of Apr 2022 and a completion of Oct 2025. It does not say whether these dates are actual or estimated.
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Klara M. Pósfay Barbe