Immunogenicity, Vaccine
Conditions
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.
Interventions
DIAGNOSTIC_TESTELISA 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.
Sponsors
Sanofi Pasteur, a Sanofi Company
University Hospital for Infectious Diseases, Croatia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Seroprevalence | up to 6 months | Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup |
Countries
Croatia
Contacts
Primary ContactGoran Tešović
Backup ContactVedran Stevanović
Outcome results
None listed