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Seroprevalence of Pertussis Among Children and Adolescents in Croatia

Primary Purpose

Immunogenicity, Vaccine

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
ELISA IgG Testkit
Sponsored by
University Hospital for Infectious Diseases, Croatia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunogenicity, Vaccine

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children and adolescents from 6 to 18 years of age treated through Emergency room and/or Day hospital of Pediatric Infectious Diseases Department at UHID;
  • appropriate vaccination with pertussis component containing vaccine by date and at the appropriate time, according to Croatian NIP proven by insight in the Vaccination Record Card
  • written informed consent obtained from the subject's parent or caregiver, as well as from participants ≥ 16 years old.

Exclusion Criteria:

  • children under 6 years
  • children and adolescents with acute respiratory symptoms
  • children and adolescents with pertussis-like illness within 12 months
  • children and adolescents with unknown, uncompleted or irregular vaccination record
  • inpatients
  • children and adolescents with immunodeficiencies

Sites / Locations

  • University Hospital for Infectious Diseases "Dr Fran Mihaljević"Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Seroprevalence of pertussis among children and adolescents in Croatia

Arm Description

For all patients participating in the study one serum sample will be collected for serological analysis.

Outcomes

Primary Outcome Measures

Waning of vaccine-induced immunity
Number of Participants In Each Specific Age Group With Negative Pertussis Toxin IgG Antibody Titre Measured by ELISA IgG Testkit

Secondary Outcome Measures

Seroprevalence
Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup

Full Information

First Posted
January 20, 2021
Last Updated
February 10, 2021
Sponsor
University Hospital for Infectious Diseases, Croatia
Collaborators
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT04725669
Brief Title
Seroprevalence of Pertussis Among Children and Adolescents in Croatia
Official Title
Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
June 14, 2022 (Anticipated)
Study Completion Date
September 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital for Infectious Diseases, Croatia
Collaborators
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pertussis is a vaccine preventable disease caused by Bordetella pertussis. Older children and adolescents with pertussis continue to be a significant source of infection for incompletely vaccinated infants who are in harm for developing severe disease. The primary objective of our study is to estimate the duration of protection elicited by the current vaccination schedule against pertussis in Croatia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunogenicity, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seroprevalence of pertussis among children and adolescents in Croatia
Arm Type
Other
Arm Description
For all patients participating in the study one serum sample will be collected for serological analysis.
Intervention Type
Diagnostic Test
Intervention Name(s)
ELISA IgG Testkit
Intervention Description
All samples will be tested for IgG antibody level to pertussis toxin using a commercial Bordetella pertussis ELISA IgG Testkit in accordance to the manufacturers' protocol in the laboratory at the University Hospital for Infectious Diseases in Zagreb.
Primary Outcome Measure Information:
Title
Waning of vaccine-induced immunity
Description
Number of Participants In Each Specific Age Group With Negative Pertussis Toxin IgG Antibody Titre Measured by ELISA IgG Testkit
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Seroprevalence
Description
Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children and adolescents from 6 to 18 years of age treated through Emergency room and/or Day hospital of Pediatric Infectious Diseases Department at UHID; appropriate vaccination with pertussis component containing vaccine by date and at the appropriate time, according to Croatian NIP proven by insight in the Vaccination Record Card written informed consent obtained from the subject's parent or caregiver, as well as from participants ≥ 16 years old. Exclusion Criteria: children under 6 years children and adolescents with acute respiratory symptoms children and adolescents with pertussis-like illness within 12 months children and adolescents with unknown, uncompleted or irregular vaccination record inpatients children and adolescents with immunodeficiencies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Goran Tešović
Phone
+385914012605
Email
gtesovic@bfm.hr
First Name & Middle Initial & Last Name or Official Title & Degree
Vedran Stevanović
Phone
+385914012787
Email
vstevanovic@bfm.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Tešović
Organizational Affiliation
University Hospital for Infectious Diseases "Dr Fran Mihaljević"
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital for Infectious Diseases "Dr Fran Mihaljević"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Tešović
Phone
+385914012605
Email
gtesovic@bfm.hr
First Name & Middle Initial & Last Name & Degree
Vedran Stevanović

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Seroprevalence of Pertussis Among Children and Adolescents in Croatia

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