Immunogenicity, VaccineNCT04725669
Seroprevalence of Pertussis Among Children and Adolescents in Croatia
A study testing ELISA IgG Testkit in people with Immunogenicity, Vaccine, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Immunogenicity, Vaccine
- What is being tested?
- ELISA IgG Testkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jan 2021to 8 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital for Infectious Diseases "Dr Fran Mihaljević"
Zagreb, 10000
Goran Tešović, +385914012605, gtesovic@bfm.hr
Vedran Stevanović
About this study
Official title: Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents
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
- Being tested
- ELISA IgG Testkit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA IgG TestkitDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ELISA IgG Testkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Seroprevalence
Prevalence of Pertussis Toxin IgG Antibody Titre At Each Specific Age Subgroup
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 Jan 2021
- Primary completion14 Jun 2022 (estimated)
- Study completion8 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunogenicity, VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital for Infectious Diseases, Croatia
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Goran Tešović, Principal investigator, University Hospital for Infectious Diseases "Dr Fran Mihaljević"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725669
- Sponsor's protocol ID
- UHID-06
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Pertussis Antibodies Among Children and Adolescents in Croatia - Investigation of the Waning Vaccine-induced Immunity in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04725669
- Acronym / sponsor ID
- UHID-06
- Conditions
- Immunogenicity, Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital for Infectious Diseases, CroatiaUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- 8 Sep 2022 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seroprevalence of pertussis among children and adolescents in Croatia | Other | Diagnostic Test: ELISA IgG TestkitFor all patients participating in the study one serum sample will be collected for serological analysis. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA IgG TestkitAll 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. | Diagnostic test | Seroprevalence of pertussis among children and adolescents in Croatia |
Primary outcome
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
1 secondary outcome
Seroprevalence
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran Tešović principal investigator
University Hospital for Infectious Diseases "Dr Fran Mihaljević"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA IgG Testkit in people with Immunogenicity, Vaccine, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goran Tešović (+385914012605, gtesovic@bfm.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waning of vaccine-induced immunity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.