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Safety study of RAZI- MMR vaccine in 18-49 years old volunteers

Clinical trial (phase 1) of RAZI- MMR vaccine in 18-49 years old volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT138904284412N1
Enrollment
40
Registered
2012-07-30
Start date
2010-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Measles. Condition 2: Mumps. Condition 3: Rubella. Measles Mumps Rubella

Interventions

we will inject 0/5 cc MMR vaccine with new mumps component (RS12).
Prevention
we will inject 0/5 cc MMR vaccine with new mumps component (RS12)

Sponsors

Razi Vaccine and Serum Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Negative history of any contact with patients infected by Measles, Rubella or Mumps viruses during the last two months; Not being under Immunocompromising treatment; Giving Informed Consent; Not being Pregnant and no plan for pregnancy within the next three months; Negative history of Autoimmune disorders; Not being under Radiotherapy; Negative history of any Chronic diseases. Exclusion Criteria: Positive history of Immunodeficiency; Positive history of Congenital disorders; Positive history of Genetic disease;Positive history of Liver disease; Positive history of Kidney disease;Temperature > 38.0 °C at the time of the first visit; Presence of an Acute Febrile disease at the time of the fist visit; Positive history of blood transfusion during the last three months; Positive history of receiving intramascular immunogluboline during the last three months; Positive history of Hypersensitivity to Vaccine; Positive history of severe adverse effect after previous MMR Vaccine injection; Positive history of active tuberculosis; Positive history of egg hypersensitivity; Positive history of thrombocytopenia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Urea. Timepoint: Before vaccination and two weeks after vaccination. Method of measurement: Autoanalyzer- Biochemical reagent ( mg/dl).;Blood cell count and differential count of white blood cell. Timepoint: Before vaccination and two weeks after vaccination. Method of measurement: cell counter.;Creatinin. Timepoint: Before vaccination and two weeks after vaccination. Method of measurement: Autoanalyzer- Biochemical reagent ( mg/dl).;Liver enzymes. Timepoint: Before vaccination and two weeks after vaccination. Method of measurement: Autoanalyzer- Biochemical reagent ( IU/ml).;Anaphylaxy. Timepoint: Within One hour after vaccination. Method of measurement: Assessed by the physician.;Allergic reaction. Timepoint: Within one hour after vaccination. Method of measurement: Assessed by the physician.;Thrombocytopenia. Timepoint: Within 6 weeks after vaccination. Method of measurement: Cell counter.;Fever. Timepoint: Within 6 weeks after vaccination. Method of measurement: Documented and assessed by the physician.;Pain of the injection site. Timepoint: Within 6 weeks after vaccination. Method of measurement: Documented and assessed by the physician.;Swelling of the injection site. Timepoint: Within 6 weeks after vaccination. Method of measurement: Documented and assessed by the physician.;Redness of the injection site. Timepoint: Within 6 weeks after vaccination. Method of measurement: Documented and assessed by the physician.;Severe headache. Timepoint: Within 6 weeks after vaccination. Method of measurement: Documented and assessed by the physician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeedeh Forghani

Razi Vaccine and Serum Research Institute

s.forghani@yahoo.com+98 26 3457 0038

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026