Clinical trial NCT02569879: Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.
Official title: Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Acellular Pertussis
Tetanus
Aspergillosis, Allergic Bronchopulmonary
Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords: Boostrix™
Bagota
maternal vaccination
Pertussis
Mortality
Morbidity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: During the 9-year period (January 2005- December 2014)
Secondary outcomes:
measure: 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
timeFrame: During the 9-year period (January 2005- December 2014)
measure: 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
timeFrame: During the 9-year period (January 2005- December 2014)
measure: Description of the total number of doses of Boostrix administered in pregnant women, after its introduction into the UMV program in Bogota
timeFrame: During the 9-year period (January 2005- December 2014)
measure: Description of the total number of doses of primary pertussis vaccine administered to infants ≤12 months of age in Bogota
timeFrame: During the 9-year period (January 2005- December 2014)
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Carrasquilla G, Porras A, Martinez S, DeAntonio R, Devadiga R, Caceres DC, Juliao P. Incidence and mortality of pertussis disease in infants <12 months of age following introduction of pertussis maternal universal mass vaccination in Bogota, Colombia. Vaccine. 2020 Oct 27;38(46):7384-7392. doi: 10.1016/j.vaccine.2020.07.046. Epub 2020 Oct 2.