Seroprevalence of Pertussis Among Children and Adolescents in Croatia

NCT04725669 | Unknown DMC

• 1 other identifier: UHID-06
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunogenicity, Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (1)

• Seroprevalence

  up to 6 months

Study Arms (1)

Seroprevalence of pertussis among children and adolescents in Croatia

OTHER

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

Diagnostic Test: ELISA IgG Testkit

Interventions

ELISA IgG Testkit 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.

Seroprevalence of pertussis among children and adolescents in Croatia

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital for Infectious Diseases "Dr Fran Mihaljević"

Zagreb, 10000, Croatia

RECRUITING

Study Officials

• Goran Tešović

  University Hospital for Infectious Diseases "Dr Fran Mihaljević"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Goran Tešović

CONTACT

+385914012605; gtesovic@bfm.hr

Vedran Stevanović

CONTACT

+385914012787; vstevanovic@bfm.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 27, 2021
• Study Start: January 15, 2021
• Primary Completion: June 14, 2022
• Study Completion: September 8, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)