Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.

February 20, 2024 updated by: GlaxoSmithKline
This study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January 2005-December 2014.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An observational, retrospective, ecological database study which involves systematic screening of the national databases of Bogota, to study pertussis related morbidity and mortality in infants ≤ 12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January 2005-December 2014.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia, 110111
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • All infants ≤12 months of age in Bogota, reported with pertussis disease in the national databases of Bogota, between January 2005 and December 2014.
  • All infants ≤12 months of age in Bogota, deceased between January 2005 and December 2014 due to pertussis disease (primary diagnosis), based on death certificate information.
  • All infants ≤12 months of age in Bogota, with ALRTI, between January 2005 and December 2014.
  • All infants ≤12 months who have received primary pertussis vaccination in Bogota, between January 2005 and December 2014.
  • All pregnant women who have received Boostrix as a part of the UMV program in Bogota, between March 2013 and December 2014.

Description

Inclusion Criteria:

• Not applicable as since this retrospective database study will include all the available aggregated data of pertussis cases, pertussis related hospitalisations and deaths, ALRTI cases, primary pertussis vaccination coverage and Boostrix vaccination coverage.

Exclusion Criteria:

• Not applicable as since this retrospective database study will include all the available aggregated data of pertussis cases, pertussis related hospitalisations and deaths, ALRTI cases, primary pertussis vaccination coverage and Boostrix vaccination coverage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants Group
  • All infants ≤12 months of age in Bogota, reported with pertussis disease in the national databases of Bogota, between January 2005 and December 2014.
  • All infants ≤12 months of age in Bogota, deceased between January 2005 and December 2014 due to pertussis disease (primary diagnosis), based on death certificate information.
  • All infants ≤12 months of age in Bogota, with ALRTI, between January 2005 and December 2014.
  • All infants ≤12 months who have received primary pertussis vaccination in Bogota, between January 2005 and December 2014.
Other: Pertussis maternal immunization
Retrospective time trend analysis before and after pertussis maternal immunization in Bogota, Colombia.
Pregnant women Group
• Pregnant women will be included in the study to assess the vaccination coverage of Boostrix from March 2013 to December 2014
Other: Pertussis maternal immunization
Retrospective time trend analysis before and after pertussis maternal immunization in Bogota, Colombia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of reported cases of hospitalisations and deaths due to pertussis in infants ≤6 weeks of age, in post-vaccination period compared to pre-vaccination period of Boostrix vaccination
Time Frame: During the 9-year period (January 2005- December 2014)
During the 9-year period (January 2005- December 2014)

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of reported cases of hospitalisations and deaths due to pertussis in infants 7 weeks to ≤12 months of age, in post-vaccination period compared to pre-vaccination period of Boostrix vaccination
Time Frame: During the 9-year period (January 2005- December 2014)
During the 9-year period (January 2005- December 2014)
Occurrence of ALRTI in infants ≤6 weeks of age and 7 weeks to ≤12 months of age, following the introduction of pertussis maternal immunisation in Bogota, Colombia
Time Frame: During the 9-year period (January 2005- December 2014)
During the 9-year period (January 2005- December 2014)
Description of the total number of doses of Boostrix administered in pregnant women, after its introduction into the UMV program in Bogota
Time Frame: During the 9-year period (January 2005- December 2014)
During the 9-year period (January 2005- December 2014)
Description of the total number of doses of primary pertussis vaccine administered to infants ≤12 months of age in Bogota
Time Frame: During the 9-year period (January 2005- December 2014)
During the 9-year period (January 2005- December 2014)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

April 14, 2018

Study Completion (Actual)

April 14, 2018

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimated)

October 7, 2015

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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