PertussisNCT04779853
Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan
An observational study of Pertussis, run by Scientific and practical center of sanitary and epidemiological expertise and monitoring at 1 site in Kazakhstan.
Trial summary
Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study. Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pertussis
- What is being tested?
- Blood samples for pertussis antibody testing
- How many people
- 520 participants
- Where
- 1 siteKazakhstan
- Study dates
- 25 Jan 2021to 5 Jul 2022
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants (≥ 10 years \& < 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.
Who may be able to join
- 10-18 years old
- Informed consent obtained from parents or guardian(s) and assent from patient.
- Enrollment following a visit at the study center.
- Documented vaccination history
- 10-18 years old
- Informed consent obtained from parents or guardian(s) and assent from patient.
- Enrollment following a visit at the study center.
- Documented vaccination history
Who cannot join
- ≤10 years and ≥ 19 years
- Pertussis immunization during the last 12 months
- No informed consent obtained from one parent or guardian.
- Immunocompromised patients
- Patients with acute infectious diseases
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Scientific and Practical Center of Sanitary and Epidemiological Expertise and Monitoring
Almaty, 050008
Manar SMAGUL, MD, +77017444681, manarka@mail.ru
NUKENOVa, MD, +77714007784, gnukenova@mail.ru
About this study
Official title: Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan: A Cross-Sectional Study
Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study.
Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk factors of pertussis infection.
Read the detailed description
Pertussis due to infection with Bordetella pertussis (B pertussis) is a well-known cause of persistent cough primarily affecting infants and young children. Repeated administration of the vaccine is often needed to reduce the disease burden and control its transmission. At this time, no data are available on the epidemiology of pertussis in adolescents and adults in Kazakhstan.
The aim of the present study is to estimate the prevalence of pertussis infection in different age groups in Kazakh children and adolescents using the anti-pertussis toxin (PT) antibodies (IgA and IgG) as specific marker of pertussis infection or vaccination. The serosurvey will be conducted in 4 different regions: Aktobe, Karaganda, Taldykorgan, and Shymkent.
Participants (≥ 10 years \& < 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.
Upon obtaining informed consent for participant parent/guardian, the study coordinator will complete an investigation form (IF) for each participant and collect serum samples. The specimens will be coded by a unique participant number and delivered to the laboratory in charge of the assay. The specimens will be used for serological analyses.
- Conditions
- Pertussis
- Being tested
- Blood samples for pertussis antibody testing
- Keywords
- pertussis, seroprevalence, immunity, antibodies, Kazakhstan, vaccination
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for pertussis antibody testingDiagnostic test
Blood samples will be sent to the laboratories of the National Centers of Expertise within 24-48 hours of blood collection. The samples will be transferred to the reference laboratory of SPCSEEM in Almaty, Kazakhstan. Serum samples will be stored in the reference laboratory at a temperature of -20 C.
| Study group | Role | What they receive |
|---|---|---|
| Pertussis antibodies testing will be conducted at the Reference Laboratory in NPCCEEM | serum samples will be taken and tested by enzyme-linked immunoassay (ELISA) using the SAVYON SeroPertussisTM kits (Savyon Diagnostics Ltd, Israel). Receives: Diagnostic Test: Blood samples for pertussis antibody testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.
To estimate the prevalence of recent infection Bp infection, using increased anti-PT antibody levels as markers of Bp infection in the serology test.
Measured: 25.01.2021-17.10.2021
Secondary outcomes (1)
The prevalence of recent Bp infection in the test in the selected population sample stratified by demographic and socio-economic criteria, vaccination history, and risk of infection.
To evaluate the risk factors associated with higher seroprevalence of pertussis.
Measured: 25.01.2021-17.10.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start25 Jan 2021
- Primary completion17 Oct 2021 (estimated)
- Study completion5 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific and practical center of sanitary and epidemiological expertise and monitoring
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779853
- Sponsor's protocol ID
- PER00075
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04779853
- Acronym / sponsor ID
- PER00075
- Conditions
- Pertussis
- Keywords
- pertussis, seroprevalence, immunity, antibodies, Kazakhstan, vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Scientific and practical center of sanitary and epidemiological expertise and monitoringUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 17 Oct 2021 (estimated)
- Study completion
- 5 Jul 2022 (estimated)
- First posted
- 3 Mar 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.
Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study.
Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk factors of pertussis infection.
Detailed description
Pertussis due to infection with Bordetella pertussis (B pertussis) is a well-known cause of persistent cough primarily affecting infants and young children. Repeated administration of the vaccine is often needed to reduce the disease burden and control its transmission. At this time, no data are available on the epidemiology of pertussis in adolescents and adults in Kazakhstan.
The aim of the present study is to estimate the prevalence of pertussis infection in different age groups in Kazakh children and adolescents using the anti-pertussis toxin (PT) antibodies (IgA and IgG) as specific marker of pertussis infection or vaccination. The serosurvey will be conducted in 4 different regions: Aktobe, Karaganda, Taldykorgan, and Shymkent.
Participants (≥ 10 years \& < 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.
Upon obtaining informed consent for participant parent/guardian, the study coordinator will complete an investigation form (IF) for each participant and collect serum samples. The specimens will be coded by a unique participant number and delivered to the laboratory in charge of the assay. The specimens will be used for serological analyses.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pertussis antibodies testing will be conducted at the Reference Laboratory in NPCCEEM | – | Diagnostic Test: Blood samples for pertussis antibody testingserum samples will be taken and tested by enzyme-linked immunoassay (ELISA) using the SAVYON SeroPertussisTM kits (Savyon Diagnostics Ltd, Israel). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants (≥ 10 years \& < 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.
Key inclusion criteria (8 listed)
- 10-18 years old
- Informed consent obtained from parents or guardian(s) and assent from patient.
- Enrollment following a visit at the study center.
- Documented vaccination history
- 10-18 years old
Key exclusion criteria (5 listed)
- ≤10 years and ≥ 19 years
- Pertussis immunization during the last 12 months
- No informed consent obtained from one parent or guardian.
- Immunocompromised patients
- Patients with acute infectious diseases
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 |
|---|---|---|
| Blood samples for pertussis antibody testingBlood samples will be sent to the laboratories of the National Centers of Expertise within 24-48 hours of blood collection. The samples will be transferred to the reference laboratory of SPCSEEM in Almaty, Kazakhstan. Serum samples will be stored in the reference laboratory at a temperature of -20 C. | Diagnostic test | Pertussis antibodies testing will be conducted at the Reference Laboratory in NPCCEEM |
Primary outcome
The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.
Time frame: 25.01.2021-17.10.2021
To estimate the prevalence of recent infection Bp infection, using increased anti-PT antibody levels as markers of Bp infection in the serology test.
1 secondary outcome
The prevalence of recent Bp infection in the test in the selected population sample stratified by demographic and socio-economic criteria, vaccination history, and risk of infection.
Time frame: 25.01.2021-17.10.2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis, run by Scientific and practical center of sanitary and epidemiological expertise and monitoring at 1 site in Kazakhstan.
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 8 inclusion and 5 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 3 Mar 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 Kazakhstan. 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 Manar SMAGUL, MD (+77017444681, manarka@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample. (time frame: 25.01.2021-17.10.2021). 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 3 Mar 2021.