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

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569879
• Other study ID #: 201521
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: April 14, 2018

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 14, 2018
• Est. primary completion date: April 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Acellular Pertussis
• Aspergillosis
• Diphtheria
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Tetanus
• Whooping Cough

Intervention

Other:
• Pertussis maternal immunization
Retrospective time trend analysis before and after pertussis maternal immunization in Bogota, Colombia.

Locations

Country	Name	City	State
Colombia	GSK Investigational Site	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Colombia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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		During the 9-year period (January 2005- December 2014)
Secondary	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)
Secondary	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)