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
Evaluation and comparison of immunogenicity of the MMR vaccines used in Iranian National Vaccination Program in 12 month old infants
Design
This is a multi-center, non-randomized, and immunogenicity lab blinded clinical trial.
Settings and conduct
Study will be conducted in selected health centers of Iran and Shahid Beheshti University of Medical Sciences. Two heel capillary blood samples will be collected by Dried Blood Spot method on filter papers at the time of MMR vaccination and 6 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 12 month old infants with normal growth and development attending health center for their first dose of MMR vaccination, parental consent. Exclusion criteria: Having medical conditions affecting child immunity such as congenital or acquired immunodeficiency, history of coagulation disorders or receiving blood products or immunoglobulins within the last three months and prior measles infection.
Intervention groups
Intervention group 1: Receiving Measles, Mumps, and Rubella (MMR) vaccine manufactured by the Razi Vaccine and Serum Research Institute. Intervention group 2: : Receiving MMR vaccine manufactured by serum institute of India
Main outcome variables
Primary outcomes: Measles-specific IgG antibody response (Seroconversion rate), Change in serum level of measles-specific IgG antibodies 6 weeks after vaccination (Geometric Mean Fold Increase (GMFI). Secondary outcomes: Non-inferiority of seroconversion rate of the Measles-specific IgG antibody in MMR vaccine manufactured by the Razi institute and serum institute of India compared with expected 85% at a margin of 10% (Adequacy of measles-specific IgG antibody response), Rubella and Mump specific IgG antibody response (Seroconversion rate), Change in serum level of Rubella and Mumps specific IgG antibodies 6 weeks after vaccination (Geometric Mean Fold Increase (GMFI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201214049709N7
Registration date:2026-07-01, 1405/04/10
Registration timing:prospective
Last update:2026-07-01, 1405/04/10
Update count:0
Registration date
2026-07-01, 1405/04/10
Registrant information
Name
Ali Eshaghi
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0038
Email address
a.eshaghi@rvsri.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-11, 1405/04/20
Expected recruitment end date
2027-01-10, 1405/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of immunogenicity of the MMR vaccines used in Iranian National Vaccination Program in 12 month old infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 12 months old to 12 months old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
420
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees Of Razi Vaccine and Serum Research Institute
Street address
Razi Vaccine and Serum Research Institute, Shahid Beheshti Blvd., Hesarak, Karaj, Alborz Province, Iran.
City
Tehran
Province
Tehran
Postal code
۳۱۹۷۵‑۱۴۸
Approval date
2025-12-02, 1404/09/11
Ethics committee reference number
IR.RVSRI.REC.1404.004
Health conditions studied
1
Description of health condition studied
Measles
ICD-10 code
B05
ICD-10 code description
Measles
2
Description of health condition studied
Rubella
ICD-10 code
B06
ICD-10 code description
Rubella [German measles]
3
Description of health condition studied
Mumps
ICD-10 code
B26
ICD-10 code description
Mumps
Primary outcomes
1
Description
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.
2
Description
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.
Secondary outcomes
1
Description
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%
2
Description
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%
3
Description
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.
4
Description
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.
Intervention groups
1
Description
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.
Category
Other
2
Description
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.