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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02569879
Enrollment
1
Registered
2015-10-07
Start date
2015-10-01
Completion date
2018-04-14
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acellular Pertussis, Aspergillosis, Allergic Bronchopulmonary, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines, Tetanus

Keywords

Boostrix™, Bagota, maternal vaccination, Pertussis, Mortality, Morbidity

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.

Interventions

OTHERPertussis maternal immunization

Retrospective time trend analysis before and after pertussis maternal immunization in Bogota, Colombia.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 12 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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 vaccinationDuring the 9-year period (January 2005- December 2014)

Secondary

MeasureTime 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 vaccinationDuring 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, ColombiaDuring 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 BogotaDuring 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 BogotaDuring the 9-year period (January 2005- December 2014)

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026