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Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan

S

Scientific and practical center of sanitary and epidemiological expertise and monitoring

Status

Unknown

Conditions

Pertussis

Treatments

Diagnostic Test: Blood samples for pertussis antibody testing

Study type

Observational

Funder types

Other

Identifiers

NCT04779853
PER00075

Details and patient eligibility

About

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.

Full 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.

Enrollment

520 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • ≤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 design

520 participants in 1 patient group

Pertussis antibodies testing will be conducted at the Reference Laboratory in NPCCEEM
Description:
serum samples will be taken and tested by enzyme-linked immunoassay (ELISA) using the SAVYON SeroPertussisTM kits (Savyon Diagnostics Ltd, Israel).
Treatment:
Diagnostic Test: Blood samples for pertussis antibody testing

Trial documents
4

Trial contacts and locations

1

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Central trial contact

Manar SMAGUL, MD; Gauhar NUKENOVA, MD

Data sourced from clinicaltrials.gov

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