The aim of this study is comparing the effect of PPV and PCV vaccines in splenectomized thalassemia major at thalassemia research center of Mazandaran University of medical sciences. Inclusion Criteria: All of Splenectomized Thalassemia Major Patients who have not received Pneumococcal Vaccine or have received it more than 5 years ago. Exclusions Criteria: Tthalassemia Major with Spleen. The outcome of this study is antibody response to pneumococcal vaccine of PPV or PCV. Before and after vaccination, blood samples are taken to check the level of pneumococcal antibodies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110116660N3
Registration date:2011-11-20, 1390/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-20, 1390/08/29
Registrant information
Name
Javad Ghafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 0054
Email address
ghafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-07-27, 1390/05/05
Expected recruitment end date
2012-07-26, 1391/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibody Response to Pneumococcal Vaccines, Polysaccharides 23 Valence (PPV) and Conjugates 7 Valence (PCV) in Beta Thalassemia Major without Spleen
Public title
Antibody Response to Pneumococcal Vaccines PPV and PCV in Beta Thalassemia Major without Spleen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Splenectomized Thalassemia Major Patients who have not received Pneumococcal Vaccine or have received it more than 5 years ago. Exclusions Criteria: Tthalassemia Major with Spleen.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
NO.2 Building, Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
Approval date
2011-08-03, 1390/05/12
Ethics committee reference number
80-90
Health conditions studied
1
Description of health condition studied
Beta Thalassemia Major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Antibody response to pneumococcal vaccines ppv
Timepoint
Evaluation of IgG eight weeks after vaccination
Method of measurement
Laboratory Test
2
Description
Antibody response to pneumococcal vaccines pcv
Timepoint
Evaluation of IgG three months after vaccination
Method of measurement
Laboratory Test
Secondary outcomes
1
Description
Along Diseases
Timepoint
After of study
Method of measurement
Laboratory Test
Intervention groups
1
Description
PPV vaccine, once, 0.5 cc
Category
Prevention
2
Description
PCV vaccine, once, 0.5 cc
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia Clinic, Boali Hospital
Full name of responsible person
Dr Javad Ghafari
Street address
Boali Hospital, P1asdaran blvd, Emam square
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
No.2 Building of Mazandaran University of Medical Sciences, Moaalem Square
City
Sari
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Javad Ghafari
Position
Alergist and Clinical Immounologist, Associate of Professor
Other areas of specialty/work
Street address
No.2 Biulding of Mazandaran University of Medical Sciences, Moaalem Square
City
Sari
Postal code
4817844718
Phone
+98 981512233011
Fax
+98 15 1223 4507
Email
javad.neg@yahoo.com , ghafari@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Javad Ghafari
Position
Alergist and Clinical Immounologist, Associate Professor
Other areas of specialty/work
Street address
Boali Hospital, Pasdaran, Emam Squar
City
Sari
Postal code
Phone
+98 15 1223 3011
Fax
Email
javad.neg@yahoo.com , ghafari@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of medical Sciences
Full name of responsible person
Dr javad Ghafari
Position
Alergist and Clinical Immounologist, Associate of Professor
Other areas of specialty/work
Street address
Boali Hospital, Pasdaran Blvd, Emam Squar
City
Sari
Postal code
Phone
Fax
Email
javad.neg@yahoo.com , ghafari@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)