In this prospective study, 558 infants and 672 children aged 4-6 years were injected with DTwP vaccine manufactured by Razi Institute of Iran (DTwP-Razi) or Sanafi-Pasteur of France (DTwP-Pasteur). All children received DTwP vaccine at 2, 4, and 6 months of age (Primary vaccination) or 4-6 years of age (booster vaccination), following the national vaccination schedule of Iran. In children, blood samples were collected before and 2-4 weeks after the vaccination and in infants 2-4 weeks after the 3rd dose (6th month) of vaccination. The immunogenicity of the vaccines was assessed by ELISA using commercial kits. Antibody against protective antigens of pertussis, including pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) was measured by designed ELISA assay. Reactogenicity was assessed by the parents for 7 days post-vaccination using diary cards. Local (pain, redness and swelling) and systemic (fever, loss of appetite, gasterointestinal symptoms, vomiting and eczema) side effects were recorded daily.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902072471N2
Registration date:2010-06-14, 1389/03/24
Registration timing:retrospective
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
Expected recruitment start date
2005-03-21, 1384/01/01
Expected recruitment end date
2007-09-23, 1386/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunogenicity and short term reactogencity of cellular DTP vaccine in Iranian children
Public title
Immunogenicity and short term reactogencity of cellular DTP vaccine in Iranian children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy children
Exclusion criteria: Incomplete vaccination card, immunodeficiency disease, severe asthma and allergy
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
600
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 Center
Street address
Avicenna Research Institute, Shahid Beheshti University.Evin.Shahid Chamran highway
City
Tehran
Postal code
19615-1177
Approval date
empty
Ethics committee reference number
83/1106
Health conditions studied
1
Description of health condition studied
DTP
ICD-10 code
Z27.1
ICD-10 code description
Need for immunization against diphtheria-tetanus-pertussis, combined [DTP]
Primary outcomes
1
Description
Antibody response against Diphtheria, Tetanus and Pertussis
Timepoint
one month
Method of measurement
ELISA
Secondary outcomes
1
Description
Comparison DTP vaccine reactogencity
Timepoint
Immediate after vaccine
Method of measurement
Checking by parents
Intervention groups
1
Description
Injecting vaccine that is approved by WHO (control group)
Category
Treatment - Drugs
2
Description
Injecting Iranian 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. Dinarvand
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 982122432020
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)