In this prospective study, 720 infants (one year old) and 720 children, aged 6 years old, were injected with MMR vaccine manufactured by Razi Institute of Iran or MMR vaccine approved by World Health Organization. Children received MMR vaccine at 12 and 18 months of age or 6 years of age, following the national vaccination schedule of Iran. In children, blood samples are collected before and 2 months after the vaccination and in infants blood is collected at 14, 18 and 20 months of age. The immunogenicity of the vaccines was assessed by ELISA using commercial kits. Reactogenicity was assessed by the physicians and parents for 2 months post-vaccination using diary cards.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806252471N1
Registration date:2010-06-14, 1389/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Saeed Zarei
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
szarei@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of food and drugs, Ministry of Health and Medical Education, Secretariat of the 4th national economical, social and cultural development plan
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of immunogenicity and short term reactogenicity of a local and a WHO approved commercial MMR vaccines in Iranian children and infants
Public title
Comparison of immunogenicity and short term reactogencity of MMR vaccine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy children
Exclusion criteria: Incomplete vaccination card, immunodeficiency disease, severe asthma and allergy
Age
From 1 year old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
720
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-----------------------------
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, Shahid Chamran highway
City
Tehran
Postal code
19615-1177
Approval date
2008-07-09, 1387/04/19
Ethics committee reference number
2442/87
Health conditions studied
1
Description of health condition studied
MMR
ICD-10 code
Z27.4
ICD-10 code description
Need for immunization against measles-mumps-rubella [MMR]
Primary outcomes
1
Description
Antibody response against Measles, Mumps and Rubella
Timepoint
Start (0), 2, 6 month after vaccination
Method of measurement
ELISA
Secondary outcomes
1
Description
vaccines reactogencity
Timepoint
Immediately and two month after vaccination
Method of measurement
Checking by parents and physician
Intervention groups
1
Description
Injecting WHO approved MMR vaccine (control group)
Category
Treatment - Drugs
2
Description
Injecting Iranian MMR Vaccine (case group)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
East Health Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of food and drugs, Ministry of health and Medical Education
Full name of responsible person
Dr. Sheibani
Street address
Fakhrerazi st, Enghelab sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of food and drugs, Ministry of health and Medical Education
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr. Fazel Shokri
Position
PhD
Other areas of specialty/work
Street address
Avicenna Research Institute, Shahid Beheshti University.Evin.Shahid Chamran highway
City
Tehran
Postal code
19615-1177
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
fazshok@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr. Fazel Shokri
Position
PhD
Other areas of specialty/work
Street address
Avicenna Research Institute, Shahid Beheshti University.Evin.Shahid Chamran highway
City
Tehran
Postal code
19615-1177
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
fazshok@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr. Saeed Zarei
Position
MD
Other areas of specialty/work
Street address
Avicenna Research Institute, Shahid Beheshti University.Evin.Shahid Chamran highway
City
Tehran
Postal code
19615-1177
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
szarei@avicenna.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)