]>
IRCT201206304412N6 IRCT 2012-07-30 Razi Vaccine & Serum Research Institute Immunogenicity and safety assessments of MMR vaccine with new mumpes component (RS12) Randomized double blind clinical trial (phase 2) RAZI- MMR vaccines in comparison with a standard vaccine in 12 – 24 months old children. 2015-08-08 anticipated 420 Complete https://irct.ir/trial/4711 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2 Condition 1: Measles. Condition 2: rubella. Condition 3: Mumps. Intervention 1: Interventional qroup: MMR vaccine with new mumps component ( RS12). Intervention 2: MMR vaccine which is used in routine vaccination.
public Seyed Mahmood Mirafzali
Razi Vaccine & Serum Research Institute, Hesarak , karaj
Karaj Iran (Islamic Republic of) 3197619751 +98 263457003846 mirmir1347@yahoo.com Razi Vaccine &Sserum Research Institute scientific Saeedeh Forghani
Razi Vaccine and Serum Research Institute, Hesarak , Karaj
Karaj Iran (Islamic Republic of) 3197619751 +98 26457003846 s.forghani@yahoo.com Razi Vaccine and Serum Research Institute Iran (Islamic Republic of) Inclusion criteria: in 12 – 24 months old children Negative history of any exposure to measeles , rubella and mumps in the the preceding 4 weeks ; Negative history of previous MMR immunization ; Negative history of immunosuppressive therapy; Negative history of previous infection by measeles , rubella and mumps viruses ; obtaining written informed consent ; Negative history of radiotherapy; Exclusion criteria : in 12 – 24 months old children Positive history of autoimmune disorders , genetic and congenital disease; Positive history of kidney and liver disease; fever of >38.cc at time of assessment; Positive history of other signs of acute infections; Positive history of administration immunoglobins or blood transfusions within the previous three months; Positive history of allergy to any vaccine components; Positive history of prematurity ,mental retardation ; Positive history of convulsion or any neurological disorder; 1 year 2 years Both B05 B06 B26 viral infections characterized by skin and mucous membraine lesions viral infections characterized by skin and mucous membraine lesions Other viral diseases Prevention Prevention Interventional qroup: MMR vaccine with new mumps component ( RS12) MMR vaccine which is used in routine vaccination Antibody titer of mumps. Timepoint: Before first vaccination and 6-8 weeks after each vaccination. Method of measurement: Eliza test. Antibody titer of rubella. Timepoint: Before first vaccination and 6-8 weeks after each vaccination. Method of measurement: Eliza test. Antibody titer of measeles. Timepoint: Before first vaccination and 6-8 weeks ater each vaccination. Method of measurement: Eliza test. Allergic reaction. Timepoint: One hour after each vaccination. Method of measurement: Assessed by the physician. Anaphylaxy. Timepoint: Half hour( 30 minutes) after each vaccination. Method of measurement: Assessed by the physician. Febrile convulsion. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Thrombocytopenia. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Encephalopathy. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Pain of injection site. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Swelling of injection site. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Redness of injection site. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Fever. Timepoint: Within 6-8 weeks after each vaccination. Method of measurement: Documented and assessed by the physician. Razi Vaccine & Serum Research Institute Approved 2011-11-19 Iranian National Ethics Committee Ministry of Health and Medical Education Ttehran Iran (Islamic Republic of)