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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants Group |
|
| |
| Pregnant women Group | • Pregnant women will be included in the study to assess the vaccination coverage of Boostrix from March 2013 to December 2014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertussis maternal immunization | Other | Retrospective time trend analysis before and after pertussis maternal immunization in Bogota, Colombia. |
|
| Measure | Description | 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 | During the 9-year period (January 2005- December 2014) |
| Measure | Description | 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 | 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bogotá | 110111 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33012607 | Background | 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. |
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| 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) |
| 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) |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D008172 | Lung Diseases, Fungal |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
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