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A Phase IV, Multicenter, Open label, Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) manufactured by Serum Institute of India ltd. in infants aged 2-7 months in Alborz Province, Iran

Protocol summary

Summary
This is an open-label, single arm post marketing study in infants aged 2-7 months. Infants who meet inclusion criteria will receive Pentavalent (DTwP-HB-Hib) vaccine (adsorbed)/Pentavac for active immunization against Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib infections. Each infant receives 0.5ml Pentavac vaccine as an intramuscularly injection into the antero-lateral aspect of thigh at 2, 4, 6 months of age. Two blood sample will be taken from enrolled infants for measurement of antibody serum titer against Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib separately, the first sample will be taken immediately before first dose injection of vaccine and the second sample will be taken 4-6 weeks after third dose injection. Immunogenicity evaluation will be performed by determination the rate of sero-protection occurrence in vaccinated infants against each part of this conjugated vaccine separately, based on comparison of serum titer antibodies results in second blood sample with the standard cut off values for sero-protection in utilized kit. Safety evaluation will be performed by determination the rate of local and systemic adverse events occurrence during two period of times, during 30 minutes immediately after each vaccine injection (reactogenicity) when vaccinated infant is observed directly by responsible physician and till one month after each vaccine injection by infant’s parents.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042027498N1
Registration date: 2016-06-10, 1395/03/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Mahmood Faramarzi
Name of organization / entity
Research Center of Pediatric Infectious Diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 6049
Email address
Faramarzimahmood@yahoo.com
Recruitment status
Recruitment complete
Funding source
Barkat Foundation
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Phase IV, Multicenter, Open label, Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) manufactured by Serum Institute of India ltd. in infants aged 2-7 months in Alborz Province, Iran
Public title
Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy infants of either sex aged 2 months at the time of first dose injection; Free of obvious health problems as established by medical history and clinical exam before entering into the study; Born after normal gestational age (36-42 weeks); Written, explained, and signed informed consent form of infant’s parents; Born to sero-negative HBsAg mothers (based on pregnancy documents or mother declaration); Born to sero-negative HIV mothers (based on pregnancy documents or mother declaration); The infant should be receive vaccination of 2/4/6 months at the same clinic and should be available after last vaccination up to two months Exclusion criteria: Use of any investigational drug or vaccine other than Pentavac during the study period or within 30 days prior the first vaccine dose; Administration of immunoglobulins or any other blood products since birth; Administration of a routine vaccine 30 days before or during the study period except BCG and OPV vaccine; History of significant and persistent hematologic, hepatic, renal, cardiac or respiratory disease; Evidence of any acute infection or fever; Axillary temperature ≥ 38.5°C; History of neurological disorders or seizure; History of allergic disease or reactions which is possibly exacerbated by any component of vaccine; Confirmed immunosuppression including HIV infection; Any congenital or hereditary immunodeficiency; Simultaneous participation in any other clinical study
Age
From 2 months old to 7 months old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 691
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
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Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran Univerity of Mediacl University (IUMS)
Street address
Besides Milad Tower, Hemmat Expressway
City
Tehran
Postal code
-
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
IR.IUMS.REC.1394.26616

Health conditions studied

1

Description of health condition studied
Diphtheria vaccine
ICD-10 code
Y58.5
ICD-10 code description
Diphtheria vaccine

2

Description of health condition studied
Tetanus vaccine
ICD-10 code
Y58.4
ICD-10 code description
Tetanus vaccine

3

Description of health condition studied
Pertussis vaccine
ICD-10 code
Y58.6
ICD-10 code description
Pertussis vaccine

4

Description of health condition studied
Haemophilus influenzae Vaccine
ICD-10 code
P23.6
ICD-10 code description
Haemophilus influenzae Vaccine

5

Description of health condition studied
Hepititis B Veccine
ICD-10 code
Y59.0
ICD-10 code description
Viral Vaccine

Primary outcomes

1

Description
Anti-Diphtheria antibody
Timepoint
One month after intervation
Method of measurement
Immunoassay

2

Description
Anti-Tetanus antibody
Timepoint
One month after intervation
Method of measurement
Immunoassay

3

Description
Anti-Hepititis B antibody (HbsAb)
Timepoint
One month after intervation
Method of measurement
Immunoassay

4

Description
Anti-Haemophilus influenzae antibody
Timepoint
One month after intervation
Method of measurement
Immunoassay

5

Description
Anti-Pertussis Antibody
Timepoint
One month after intervation
Method of measurement
Immunoassay

Secondary outcomes

1

Description
Adverse clinical symptoms of vaccinination
Timepoint
One month after vaccination
Method of measurement
Evaluation of Symptoms

Intervention groups

1

Description
Two blood sample will be taken from enrolled infants for measurement of antibody serum titer against Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib separately, the first sample will be taken immediately before first dose injection of vaccine and the second sample will be taken 4-6 weeks after third dose injection.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Turkian Health Center
Full name of responsible person
Street address
City
Karaj

2

Recruitment center
Name of recruitment center
Hesarak Health Center
Full name of responsible person
Street address
City
Karaj

3

Recruitment center
Name of recruitment center
Shohadaey Meshkin-Shahr Health Center
Full name of responsible person
Street address
City
Karaj

4

Recruitment center
Name of recruitment center
Shohadaey Fardis Health Center
Full name of responsible person
Street address
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Biosun Farmed (Barkat Foundation)
Full name of responsible person
DR. Taghavian
Street address
No.6, St No.8, Bokharest St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Biosun Farmed (Barkat Foundation)
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
Research Center of Pediatric Infectious Diseases
Full name of responsible person
Mahmood Faramarzi
Position
MS.c. of Medical Immunology
Other areas of specialty/work
Street address
Sattar khan St, Niayesh St, Hazrat-e-Rasool Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6651 6049
Fax
Email
Faramarzimahmood@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Center of Pediatric Infectious Diseases
Full name of responsible person
Hossein Masoumi-Asl
Position
MD of Pediatric Infectious Diseases
Other areas of specialty/work
Street address
Sattar khan St, Niayesh St, Hazrat-e-Rasool Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6651 6049
Fax
Email
Dr_masoumiasl@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mahmood Faramarzi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 913 841 1980
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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