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

Completed

• Conditions: Acellular Pertussis; Tetanus; Aspergillosis, Allergic Bronchopulmonary; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines
• Interventions: Other: Pertussis maternal immunization

• Registration Number: NCT02569879
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

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 Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Primary Completion: 2018-04-14
• Study Completion: 2018-04-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women Group	Pertussis maternal immunization	• Pregnant women will be included in the study to assess the vaccination coverage of Boostrix from March 2013 to December 2014
Infants Group	Pertussis maternal immunization	* 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.

Primary Outcome Measures

Name	Time	Method
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	During the 9-year period (January 2005- December 2014)

Secondary Outcome Measures

Name	Time	Method
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	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	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	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	During the 9-year period (January 2005- December 2014)

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇴 Bogota, Colombia