CClinicalTrials.gg
CompletedNCT02569879Updated Feb 22, 2024

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

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

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
1
Ages
0 Days to 12 Months
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • Boostrix™
  • Bagota
  • maternal vaccination
  • Pertussis
  • Mortality
  • Morbidity
03

Who can participate

Ages eligible
0 Days to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • Infants Group

    * 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 Group

    • 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

Interventions

  • OtherPertussis maternal immunization

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

05

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

06

Study locations

1 site
  • GSK Investigational Site
    Bogota, 110111, Colombia
07

References and documents

Publications

  • 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. PubMed 33012607 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT02569879
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 7, 2015
Start date
Oct 1, 2015
Primary completion
Apr 14, 2018
Completion
Apr 14, 2018
Last update
Feb 22, 2024

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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