Study of seroconversion rate of anti-measles antibodyafter vaccination with each measles vaccine strains which are in routine use in Iran(AIK-C and Edmonston-Zagreb) in 9 to 12 months infants of Zahedan District; a randomized controlled trial; Sistan-va-Baluchestan province of Iran; Fall 2015
The main objective of this study was comparison of effectiveness of two kinds of anti-measles vaccines which are in routine use in immunization program of I.R.Iran. One of the vaccines is produced by Razi Institute of Serum and Vaccine Production and the other is Serum Institute of India. The first vaccine contains the AIK-C stain of measles vaccine and the other contains the Edmonston-Zagreb strain.
Study population: Children 9 to 12 months of age resident in Zahedan, I.R.Iran.
Inclusion criteria: The age of 9 to 12 months of age.
Exclusion criteria: history of receiving measles containing vaccines and being a traveler to Zahedan.
Sample size: total: 200 children. 100 in each arm.
In four urban health centers the participants in the mentioned age range will be randomly allocated to one of the two arms of the study. In one arm the ‘measles-rubella’ (MR) vaccine produced by Razi Institute of Vaccine and Serum production and in the other arm MR vaccines produced by Serum institute of India will be administered. The cold chain and inoculation practices will be checked strictly. All the health workers in the study are well trained and educated. Supervision and quality control will be administered both in the district and in the provincial levels. Before vaccination and two months after vaccination serum samples will be taken from all participants. All lab tests will be performed in the National Reference Laboratory for Measles in Tehran University of Medical Sciences.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016032827144N1
Registration date:2016-05-10, 1395/02/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
Shahrokh Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5621 3729
Email address
izadish@yahoo.com
Recruitment status
Recruitment complete
Funding source
Centre for Communicable Diseases Control, Ministry of Health and Medical Education, I.R.Iran.
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-05-28, 1395/03/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of seroconversion rate of anti-measles antibodyafter vaccination with each measles vaccine strains which are in routine use in Iran(AIK-C and Edmonston-Zagreb) in 9 to 12 months infants of Zahedan District; a randomized controlled trial; Sistan-va-Baluchestan province of Iran; Fall 2015
Public title
Measles-Rebella vaccination study.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: all children in the mentioned age rang.
Exclusion criteria: positive history of inoculation of any kind of measles containing vaccine; being a temporary resident for the next 3 months in the region.
Age
From 9 months old to 12 months old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Medical Research of Zahedan University of Medical Sciences
Street address
Pardis Daneshgah Olum Pezeshki, Dr Hesabi Square
City
Zahedan, Dr Hesabi Square, Pardis Daneshgah Olum Pezeshki
Postal code
9816743174
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.ZAUMS.REC.1395.26
Health conditions studied
1
Description of health condition studied
Need for immunization against measles alone & Need for immunization against rubella alone
ICD-10 code
Z24.4 & Z2
ICD-10 code description
Need for immunization against measles alone & Need for immunization against rubella alone
Primary outcomes
1
Description
appearence of anit-measles antibodies 8 weeks after vaccination
Timepoint
8 weeks after vaccination
Method of measurement
measurment of antibody response using ELISA
Secondary outcomes
1
Description
appearence of anti-rubella antibodies
Timepoint
8 weeks after vaccination
Method of measurement
ELISA
Intervention groups
1
Description
The AIK-C group: This group will receive the measles-rubella vaccine produced by Razi Institute of Serum and Vaccine Production.
Category
Treatment - Other
2
Description
Edmonston-Zagreb group: In this group children will receive the measles-rubella vaccine produced by Serum Institute of India.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Balal Urban Health Centre
Full name of responsible person
Shahrokh Izadi
Street address
Shirabad
City
Zahedan
2
Recruitment center
Name of recruitment center
Barazandeh the Martir Urban Health Centre
Full name of responsible person
Shahrokh Izadi
Street address
Karim-abad
City
Zahedan
3
Recruitment center
Name of recruitment center
Hazrat Valiasr Urban Health Centre
Full name of responsible person
Shahrokh Izadi
Street address
End of Beheshti St.
City
Zahedan
4
Recruitment center
Name of recruitment center
Hazrat Abolfazl Urban Health Centre
Full name of responsible person
Shahrokh Izadi
Street address
End of Shariati St.
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Centre for Communicable Diseases Control, Ministry of Health and Medical Education
Full name of responsible person
Seyed Mohsen Zahraei
Street address
Nasr5 building, Falamak street, Shahrak Gharb
City
Tehran
Grant name
اولویت های پژوهشی
Grant code / Reference number
d304/13893; 17.11.2015
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Centre for Communicable Diseases Control, 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
Health Promotion Research Centre, School of Public Health, Zahedan University of Medical Sciences
Full name of responsible person
Dr Shahrokh Izadi
Position
Faculty of School of Public Health/ MD; PhD
Other areas of specialty/work
Street address
Pardis Daneshgah Olum Pezeshki, Dr Hesabi square
City
Zahedan
Postal code
Phone
+98 21 5621 3729
Fax
Email
izadish@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health, Zahedan University of Medical Sciences,
Full name of responsible person
Shahrokh Izadi
Position
Faculty of School of Public Health/ MD; PhD
Other areas of specialty/work
Street address
Pardis Daneshgah Olum Pezeshki, Dr Hesabi Square
City
Zahedan
Postal code
Phone
+98 21 5621 3729
Fax
Email
izadish@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Public Health, Zahedan Unviersity of Medical Sciences
Full name of responsible person
Shahrokh Izadi
Position
Faculty of School of Public Health/ MD; PhD
Other areas of specialty/work
Street address
Pardis Daneshgah Olum Pezeshki, Dr Hesabi Sauare
City
Zahedan
Postal code
Phone
+98 21 5621 3729
Fax
Email
izadish@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)