Seroprevalence of Pertussis Among Children and Adolescents in Croatia

NCT ID: NCT04725669

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-09-08

Brief Summary

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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

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Conditions

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Immunogenicity, Vaccine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

ELISA IgG Testkit

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

University Hospital for Infectious Diseases, Croatia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Goran Tešović

Role: PRINCIPAL_INVESTIGATOR

University Hospital for Infectious Diseases "Dr Fran Mihaljević"

Locations

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University Hospital for Infectious Diseases "Dr Fran Mihaljević"

Zagreb, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Goran Tešović

Role: CONTACT

+385914012605

Vedran Stevanović

Role: CONTACT

+385914012787

Facility Contacts

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Goran Tešović

Role: primary

+385914012605

Other Identifiers

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UHID-06

Identifier Type: -

Identifier Source: org_study_id

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