An observational study in Diphtheria, Acellular Pertussis and Tetanus, sponsored by GlaxoSmithKline. Completed at 1 site in Colombia. Open to participants aged 0 Days to 12 Months. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by GlaxoSmithKline · Observational
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.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 1 is below the median of 970 across 24 observational studies indexed under Diphtheria.
Browse Diphtheria studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
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Exclusion Criteria:
* 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
• 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.
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)
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)
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)
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)
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)
Plan to share: No
Ran from Oct 2015 to primary completion in Apr 2018, 30 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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