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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Diphtheria; Tetanus; Aspergillosis, Allergic Bronchopulmonary; Diphtheria-Tetanus-acellular Pertussis Vaccines; Acellular Pertussis

Treatments: Other: Pertussis maternal immunization

Study type: Observational

Funder types: Industry

Identifiers

NCT02569879

201521

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 2 patient groups

Infants Group

Description:

* 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.

Treatment:

Other: Pertussis maternal immunization

Pregnant women Group

Description:

• Pregnant women will be included in the study to assess the vaccination coverage of Boostrix from March 2013 to December 2014

Treatment:

Other: Pertussis maternal immunization