Seroprevalence of Pertussis Among Children and Adolescents in Croatia

February 10, 2021 updated by: University Hospital for Infectious Diseases, Croatia

Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital for Infectious Diseases "Dr Fran Mihaljević"
        • Contact:
        • Sub-Investigator:
          • Vedran Stevanović

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Seroprevalence of pertussis among children and adolescents in Croatia
For all patients participating in the study one serum sample will be collected for serological analysis.
Diagnostic test: ELISA IgG Testkit
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waning of vaccine-induced immunity
Time Frame: 1 day
Number of Participants In Each Specific Age Group With Negative Pertussis Toxin IgG Antibody Titre Measured by ELISA IgG Testkit
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevalence
Time Frame: up to 6 months
Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital for Infectious Diseases, Croatia

Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

  • Principal Investigator: Goran Tešović, University Hospital for Infectious Diseases "Dr Fran Mihaljević"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Anticipated)

June 14, 2022

Study Completion (Anticipated)

September 8, 2022

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHID-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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