Seroprevalence of Pertussis Among Children and Adolescents in Croatia

Immunogenicity, Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725669
• Other study ID #: UHID-06
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: September 8, 2022

Study information

• Verified date: February 2021
• Source: University Hospital for Infectious Diseases, Croatia
• Contact: Goran Tešovic
• Phone: +385914012605
• Email: gtesovic[@]bfm.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 8, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunogenicity, Vaccine
• Whooping Cough

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital for Infectious Diseases "Dr Fran Mihaljevic"	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital for Infectious Diseases, Croatia	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seroprevalence	Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup	up to 6 months