comparison of pneumococcal serotypes separated from nasopharynx in children 6 months to 5 years old referred to before and after pneumococcal vaccination
This non randomized quasi experimental trial was designed for evaluating the effect of pneumococcal conjugated Prevnar 13 vaccine on colonization of pneumococcus and type of serotypes. Fifty eight children with age of 6 months to 5 years without any serious diseases such as cardiac or pulmonary disease or diabetes, whom referred to pediatric clinics of Rasoul Akram Hospital, will participate to this trial after giving their parents an informed consent. All subjects will take a single dose from pneumococcal conjugated Prevnar 13. Vaccine intramuscular in their thigh or left Deltoid muscle by one educated person. One month before and 1 year after vaccination, we will take a sample from all participants’ nasopharynx and investigate for colonization after 2 days culture. We also will determine type of serotypes before and one year after vaccination and will compare them together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080510497N1
Registration date:2012-12-29, 1391/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-29, 1391/10/09
Registrant information
Name
Samileh Noorbakhsh
Name of organization / entity
Research Center of Pediatric Infectious Diseases,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 6049
Email address
s-noorbakhsh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of pneumococcal serotypes separated from nasopharynx in children 6 months to 5 years old referred to before and after pneumococcal vaccination
Public title
Effect of vaccination on nasopharyngeal pneumococcus serotype
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All children with age of 6 months to 5 years referred to pediatric clinics of Rasoul Akram Hospital after filling the consent letter by their patents.
Exclusion criteria: Previous disease including diabetes, spina bifida, asplenia, sickle cell anemia, innate or acquired immune system deficiency, previous cochlear implantation, chronic cardiac and pulmonary disease.
Age
From 1 year old to 5 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Research Center for Pediatric Infectious Diseases, 4th floor of Rasoul Akram Hospital, Niayesh St, Sattarkhan Ave
On month before and one year after injection of Prevnar vaccine
Method of measurement
Culture
Secondary outcomes
empty
Intervention groups
1
Description
Injection of one dose (0.5 ml) Prevnar 13 Produced by Pfizer company intramuscular (thigh in infants or upper arm in children). Comparing the pharyngeal colonization of pnemococus before and after vaccination.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Samileh Noorbakhsh
Street address
Research Center for Pediatric Infectious Diseases, 4th floor of Rasoul Akram Hospital, Niayesh St, Sattarkhan Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
4th floor, Main Building of Tehran University of Medical sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran 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
Research Center for Pediatric Infectious Diseases
Full name of responsible person
Samileh Noorbaksh
Position
Head of Centre
Other areas of specialty/work
Street address
Research Center for Pediatric Infectious Diseases, 4th floor of Rasoul Akram Hospital, Niayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 6049
Fax
+98 21 6651 6049
Email
cpidir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center for Pediatric Infectious Diseases
Full name of responsible person
Samileh Noorbakhsh
Position
Specialist in pediatric infectious, MD
Other areas of specialty/work
Street address
Research Center for Pediatric Infectious Diseases, 4th floor of Rasoul Akram Hospital, Niayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 6049
Fax
+98 21 6651 6049
Email
cpidir@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center for Pediatric Infectious Diseases
Full name of responsible person
Samileh Noorbakhsh
Position
Specialist in pediatric infectious, MD
Other areas of specialty/work
Street address
Research Center for Pediatric Infectious Diseases, 4th floor of Rasoul Akram Hospital, Niayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 6049
Fax
+98 21 6651 6049
Email
cpidir@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)