Seroprevalence of Pertussis Among Children and Adolescents in Croatia

Not Applicable

• Conditions: Immunogenicity, Vaccine
• Interventions: Diagnostic Test: ELISA IgG Testkit

• Registration Number: NCT04725669
• Lead Sponsor: University Hospital for Infectious Diseases, Croatia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-15
• Primary Completion: 2022-06-14
• Study Completion: 2022-09-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seroprevalence of pertussis among children and adolescents in Croatia	ELISA IgG Testkit	For all patients participating in the study one serum sample will be collected for serological analysis.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Seroprevalence	up to 6 months	Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup

Trial Locations

Locations (1)

University Hospital for Infectious Diseases "Dr Fran Mihaljević"; 🇭🇷 Zagreb, Croatia