Evaluation of the immunogenicity and safty of the
pentavalent vaccine used in national immunization program
compared with the same vaccines from the other
pharmaceutical companies
In this study we want to evaluate immunogenicity and safety of the Pentavalent vaccine used in national immunization programs compared with the same vaccines from two other pharmaceutical companies in appropriate time interval before and after vaccination. The comparison groups are children using pentavalent vaccine of Sanofi Pasteur (SHAN5) and biofarma company which have preqaulification (PQ) from WHO. And these two groups are being compared with children using Indian vaccine from Serum Institute in regards of antibody production against components of vaccine. In this way we will promote and expand the national vaccination programm after assurance of this vaccine efficacy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051222234N1
Registration date:2016-09-05, 1395/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Maryam Rajabnejad
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 6941
Email address
m_rajabnejad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Institute for Medical Research Development
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the immunogenicity and safty of the
pentavalent vaccine used in national immunization program
compared with the same vaccines from the other
pharmaceutical companies
Public title
Evaluation of the immunogenicity of the
pentavalent vaccine
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1. Healthy 2 -month-old infant boy or girl who is referred for routine vaccination
2. Infant disease is not identified at the time of visit
3. Upon arriving at the physical examination is normal nursing
4. Parents of infants in the study were successful login and sign the informed consent form
5. infants with gestational age of 38 weeks of a normal pregnancy and birth weight ≥ 2.5 kg
Exclusion criteria:
1. The use of any vaccine or drug, vaccine research studies except during the study period or 30 days prior to study entry
2. History of blood transfusions or blood products or immunoglobulin consumption
3. History of heart, respiratory, kidney, liver and blood disease
4. Known genetic or congenital immune deficiency
5. Participation in other clinical studies
Age
From 2 months old to 7 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1200
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
National Institute for Medical Research Development
Street address
National Institute for Medical Research Development, Azadi st.
City
Tehran
Postal code
Approval date
2016-04-04, 1395/01/16
Ethics committee reference number
IR.NIMAD.REC.1395.002
Health conditions studied
1
Description of health condition studied
pentavalent vaccine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of antibody (IgG) titer against each of components of the vaccine (Diphtheria, Tetanus, Pertussis, Hepatitis B and H.influenzae) following vaccination with pentavalent vaccine in ages of 2, 4 and 6 months
Timepoint
2, 7 months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Safety of pentavalent vaccine
Timepoint
Adverse event of vaccine
Method of measurement
Observation
Intervention groups
1
Description
group 1 (case): give biofarma vaccine
Category
Prevention
2
Description
group 1(control): give routine pentavalent vaccine
Category
Prevention
3
Description
group 2 (case) : give shan5 vaccine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiye hospital
Full name of responsible person
Street address
shoush - fadaiyan eslam ave - shishegar khane
City
Tehran
2
Recruitment center
Name of recruitment center
East Tehran Health Center
Full name of responsible person
Street address
emamat - jadidi ave - aboureyhan
City
Tehran
3
Recruitment center
Name of recruitment center
Ershad vaccination center
Full name of responsible person
Street address
shariati - eshraghi ave-
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr Esalatmanesh
Street address
National Institute for Medical Research Development, Azadi Ave., Between Gharib and Eskandari Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Pediatric Infections Research Center
Full name of responsible person
Maryam Rajabnejad
Position
Pediatrician
Other areas of specialty/work
Street address
Mofid hospital
City
Tehran
Postal code
Phone
+98 21 2222 6941
Fax
Email
pediatric_center@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric Infections Research Center
Full name of responsible person
Sedighe Rafiei Tabatabaei
Position
Subespecialist of infectouse diseaese
Other areas of specialty/work
Street address
Mofid hospital
City
Tehran
Postal code
Phone
+98 21 2222 6941
Fax
Email
pediatric_center@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Infections Research Center
Full name of responsible person
Maryam Rajabnejad
Position
Pediatrician
Other areas of specialty/work
Street address
Mofid hospital
City
Tehran
Postal code
Phone
+98 21 2222 6941
Fax
Email
pediatric_center@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)