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IRCT20201214049709N7 IRCT 2026-07-01 Razi Vaccine and Serum Research Institute Evaluation of immunogenicity of the MMR vaccines used in Iranian National Vaccination Program in 12 month old infants Evaluation and comparison of immunogenicity of the MMR vaccines used in Iranian National Vaccination Program in 12 month old infants, a non-randomized clinical trial 2026-07-11 anticipated 420 Recruiting https://irct.ir/trial/88653 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Immunogenicity will be assessed simultaneously for the two MMR vaccines currently used in the Iranian National Vaccination Program. All samples will be coded before being sent to the reference laboratory. Study statistician will also be unaware of the type of vaccine received by each participant. 3 Condition 1: Measles. Condition 2: Rubella. Condition 3: Mumps. Intervention 1: Intervention group 1: Infants in this group will receive the MMR vaccine (Mumps, Measles, and Rubella) manufactured by Razi vaccine and serum research institute. This vaccine is one of the vaccines used in the Iranian National Vaccination Program. Intervention 2: Intervention group 2: Infants in this group will receive the MMR vaccine (Mumps, Measles, and Rubella) manufactured by serum institute of India. This vaccine is one of the vaccines used in the Iranian National Vaccination Program. Yes - There is a plan to make this available What will be shared: Immunogenicity of MMR data When: A year after completion of study To whom: Academic institution Conditions: A joint project should be defined and approved by Razi Vaccine and Serum Research Institute Where to obtain: Please send your requests to Dr Ladan Mokhberosafa at lady.katbi@yahoo.com or l.mokhber@rvsri.ac.ir How to obtain: Any joint project needs approval from vice chancellor for research and RVSRI ethics committee Comments: -
public Ladan Mokhberosafa
Shahid Beheshti st.,
Karaj, Hesarak Iran (Islamic Republic of) 3197619751 +98 26 3405 0400 ext. 3039 lady.katbi@yahoo.com Razi Vaccine and Serum Research Institute scientific Masoud Solaymani-Dodaran
Hemmat freeway, next to Milad tower
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4751 msdodran@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 12 month old infants attending health center for their first dose of MMR vaccination Signed written informed consent by parents or legal guardian Having normal weight and height according to developmental curves Living in the area covered by the Health center and no plans to move in the next 6 weeks 12 months 12 months Both History of receiving blood products or immunoglobulins within the last three months Having medical conditions affecting child immunity such as congenital or acquired immunodeficiency History of measles infection authenticated by a health professional Un-collaborative parents History of infertility or IVF in parents prior to conception of this child History of coagulation disorders in the child B05 B06 B26 Measles Rubella [German measles] Mumps Other Other Intervention group 1: Infants in this group will receive the MMR vaccine (Mumps, Measles, and Rubella) manufactured by Razi vaccine and serum research institute. This vaccine is one of the vaccines used in the Iranian National Vaccination Program. Intervention group 2: Infants in this group will receive the MMR vaccine (Mumps, Measles, and Rubella) manufactured by serum institute of India. This vaccine is one of the vaccines used in the Iranian National Vaccination Program. Measles-specific IgG antibody response (Seroconversion rate): In this outcome, we will measure the proportion of participants whose ELISA IgG antibody test results become positive after 6 weeks. This proportion will be calculated both with and without inclusion of borderline positive ELISA test results in the numerator. Timepoint: Measurements will done at the time of administration of the MMR vaccine (Day 0) and 6 weeks later. Method of measurement: Capillary blood will be collected on filter papers using heel puncture and Dried Blood Spot method. Antibody measurements will be done by ELISA method at National Measles Surveillance center. Change in serum level of measles-specific IgG antibodies 6 weeks after vaccination (Geometric Mean Fold Increase (GMFI): Geometric mean concentration (GMC) of antibodies will be measured and compared at the time of vaccination and 6 weeks later. Timepoint: Measurements will done at the time of administration of the MMR vaccine (Day 0) and 6 weeks later. Method of measurement: Capillary blood will be collected on filter papers using heel puncture and Dried Blood Spot method. Antibody measurements will be done by ELISA method at National Measles Surveillance center. Adequacy of measles-specific IgG antibody response following the first dose of MMR vaccine manufactured by the Razi Vaccine and Serum Research Institute. Timepoint: This outcome will be calculated at the end of the study. Method of measurement: Non-inferiority of seroconversion rate of the Measles-specific IgG antibody in MMR vaccine manufactured by the Razi institute will be assessed. Comparison will be made to the expected seroconversion rate of 85% at a margin of 10%. Adequacy of measles-specific IgG antibody response following the first dose of MMR vaccine manufactured by the Serum Institute of India. Timepoint: This outcome will be calculated at the end of the study. Method of measurement: Non-inferiority of seroconversion rate of the Measles-specific IgG antibody in MMR vaccine manufactured by the Serum Institute of India will be assessed. Comparison will be made to the expected seroconversion rate of 85% at a margin of 10%. Rubella and Mump specific IgG antibody response (Seroconversion rate): In this outcome, we will measure the proportion of participants whose ELISA IgG antibody test results become positive after 6 weeks. This proportion will be calculated both with and without inclusion of borderline positive ELISA test results in the numerator. Timepoint: Measurements will done at the time of administration of the MMR vaccine (Day 0) and 6 weeks later. Method of measurement: Capillary blood will be collected on filter papers using heel puncture and Dried Blood Spot method. Antibody measurements will be done by ELISA method at National Measles Surveillance center. Change in serum level of Rubella and Mumps specific IgG antibodies 6 weeks after vaccination (Geometric Mean Fold Increase (GMFI): Geometric mean concentration (GMC) of antibodies will be measured and compared at the time of vaccination and 6 weeks later. Timepoint: Measurements will done at the time of administration of the MMR vaccine (Day 0) and 6 weeks later. Method of measurement: Capillary blood will be collected on filter papers using heel puncture and Dried Blood Spot method. Antibody measurements will be done by ELISA method at National Measles Surveillance center. Razi Vaccine and Serum Research Institute Approved 2025-12-02 Research Ethics Committees Of Razi Vaccine and Serum Research Institute Razi Vaccine and Serum Research Institute, Shahid Beheshti Blvd., Hesarak, Karaj, Alborz Province, Iran. Tehran Tehran Iran (Islamic Republic of)