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Seroprevalence of Pertussis Among Children and Adolescents in Croatia

Sponsor
University Hospital for Infectious Diseases, Croatia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725669
Collaborator
Sanofi Pasteur, a Sanofi Company (Industry)
1,500
Enrollment
1
Location
1
Arm
19.7
Anticipated Duration (Months)
76
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ELISA IgG Testkit
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Jun 14, 2022
Anticipated Study Completion Date :
Sep 8, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Waning of vaccine-induced immunity [1 day]

    Number of Participants In Each Specific Age Group With Negative Pertussis Toxin IgG Antibody Titre Measured by ELISA IgG Testkit

Secondary Outcome Measures

  1. Seroprevalence [up to 6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital for Infectious Diseases "Dr Fran Mihaljević" Zagreb Croatia 10000

Sponsors and Collaborators

  • University Hospital for Infectious Diseases, Croatia
  • Sanofi Pasteur, a Sanofi Company

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital for Infectious Diseases, Croatia
ClinicalTrials.gov Identifier:
NCT04725669
Other Study ID Numbers:
  • UHID-06
First Posted:
Jan 27, 2021
Last Update Posted:
Feb 15, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Whooping Cough

Study Results

No Results Posted as of Feb 15, 2021