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Seroprevalence of Pertussis Among Children and Adolescents in Croatia

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ClinicalTrials.gov Identifier: NCT04725669
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
University Hospital for Infectious Diseases, Croatia

Study Description
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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
Immunogenicity, Vaccine Diagnostic Test: ELISA IgG Testkit Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 15, 2021
Estimated Primary Completion Date : June 14, 2022
Estimated Study Completion Date : September 8, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Waning of vaccine-induced immunity [ Time Frame: 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 [ Time Frame: up to 6 months ]
    Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725669


Contacts
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Contact: Goran Tešović +385914012605 gtesovic@bfm.hr
Contact: Vedran Stevanović +385914012787 vstevanovic@bfm.hr

Locations
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Croatia
University Hospital for Infectious Diseases "Dr Fran Mihaljević" Recruiting
Zagreb, Croatia, 10000
Contact: Goran Tešović    +385914012605    gtesovic@bfm.hr   
Sub-Investigator: Vedran Stevanović         
Sponsors and Collaborators
University Hospital for Infectious Diseases, Croatia
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Goran Tešović University Hospital for Infectious Diseases "Dr Fran Mihaljević"
More Information
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Responsible Party: University Hospital for Infectious Diseases, Croatia
ClinicalTrials.gov Identifier: NCT04725669    
Other Study ID Numbers: UHID-06
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Respiratory Tract Diseases