A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

NCT02014519 | Completed Results

• 1 other identifier: 116804
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

Conditions

Pertussis; Pertussis Vaccines

Keywords

Adults; Hungary; Bordetella pertussis; Seroprevalence; Pertussis antibodies

Outcome Measures

Primary Outcomes (4)

• Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations

  Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 Optical Density (OD) units)

  At the time of enrollment of each subject (Day 0)

• Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection

  The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units

  At the time of enrollment of each subject (Day 0)

• Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection

  The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

  At the time of enrollment of each subject (Day 0)

• Number of Seronegative Subjects in Terms of Anti-PT Concentrations

  Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

  At the time of enrollment of each subject (Day 0)

Secondary Outcomes (33)

• Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)

  At the time of enrollment of each subject (Day 0).

• Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)

  At the time of enrollment of each subject (Day 0)

• Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)

  At the time of enrollment of each subject (Day 0)

• Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)

  At the time of enrollment of each subject (Day 0)

• Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)

  At the time of enrollment of each subject (Day 0)

Study Arms (1)

Study Group

OTHER

Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.

Procedure: Blood sampling; Other: Data collection

Interventions

Blood sampling PROCEDURE

A blood sample (2.5 mL) will be collected from all subjects

Study Group

Data collection OTHER

Active questioning

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent will be obtained from subjects prior to performing any study procedures.
• Males or females ≥ 18 years of age at the time of enrollment.
• Agreeing to collection of a blood sample for the study.

You may not qualify if:

• Confirmed or suspected immunological disorder.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Budapest, 1136, Hungary

Location

GSK Investigational Site

Budapest, 1182, Hungary

Location

GSK Investigational Site

Debrecen, 4027, Hungary

Location

GSK Investigational Site

Kecskemét, 6000, Hungary

Location

GSK Investigational Site

Zirc, 8420, Hungary

Location

Related Publications (1)

• Torzsa P, Devadiga R, Tafalla M. Seroprevalence of Bordetella pertussis antibodies in adults in Hungary: results of an epidemiological cross-sectional study. BMC Infect Dis. 2017 Apr 4;17(1):242. doi: 10.1186/s12879-017-2356-2.

  PMID: 28376739 BACKGROUND

MeSH Terms

Conditions

Whooping Cough

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: April 24, 2014
• Primary Completion: April 22, 2015
• Study Completion: April 24, 2015
• Last Updated: November 26, 2019
• Results First Posted: December 17, 2018

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

HU (5)