NCT04779853

Brief 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 factors of pertussis infection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

January 25, 2021

Last Update Submit

March 1, 2021

Conditions

Pertussis

Keywords

pertussisseroprevalenceimmunityantibodiesKazakhstanvaccination

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    25.01.2021-17.10.2021

Other Outcomes (1)

  • • Adherence to vaccination status defined as the. number and timeliness of doses received and potential exposure to booster vaccination as well as the concordance with the Kazakh vaccination status.

    25.01.2021-17.10.2021

Study Arms (1)

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).

Diagnostic Test: Blood samples for pertussis antibody testing

Interventions

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.

Pertussis antibodies testing will be conducted at the Reference Laboratory in NPCCEEM

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific and Practical Center of Sanitary and Epidemiological Expertise and Monitoring

Almaty, 050008, Kazakhstan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study will be a cross-sectional serosurvey of anti-PT levels in a sample of the population. The study will be conducted in the cities of Aktobe, Karaganda, Taldykorgan, and Shymkent. Enrollment will be done in health centers and pediatric hospitals.

MeSH Terms

Conditions

Whooping Cough

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Manar SMAGUL, MD

CONTACT

+77017444681manarka@mail.ru

Gauhar NUKENOVA, MD

CONTACT

+77714007784gnukenova@mail.ru

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

March 3, 2021

Study Start

January 25, 2021

Primary Completion

October 17, 2021

Study Completion

July 5, 2022

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

KA(1)