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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201206304412N6

Enrollment

420

Registered

2012-07-30

Start date

2015-08-08

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: rubella. Condition 3: Mumps. viral infections characterized by skin and mucous membraine lesions viral infections characterized by skin and mucous membraine lesions Other viral diseases

Interventions

Intervention 1: Interventional qroup: MMR vaccine with new mumps component ( RS12). Intervention 2: MMR vaccine which is used in routine vaccination.

Prevention

Interventional qroup: MMR vaccine with new mumps component ( RS12)

MMR vaccine which is used in routine vaccination

Eligibility

Sex/Gender

All

Age

1 Years to 2 Years

Inclusion criteria

Inclusion criteria: 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;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mahmood Mirafzali

Razi Vaccine &Sserum Research Institute

mirmir1347@yahoo.com+98 263457003846

Outcome results

None listed

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