Last updated: 02/20/2024 08:40:43

Impact of Boostrix™ maternal vaccination on morbidity and mortality of pertussis disease in infants ≤6 weeks of age, in Bogota, Colombia.

GSK study ID
201521
See study documents
Clinicaltrials.gov ID
NCT02569879
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Impact of Boostrix™ maternal vaccination on morbidity and mortality of pertussis disease in infants ≤6 weeks of age, in Bogota, Colombia.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: During the 9-year period (January 2005- December 2014)

Secondary outcomes:

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: During the 9-year period (January 2005- December 2014)

Interventions:
  • Other: Pertussis maternal immunization
    • Enrollment:
    1
    Primary completion date:
    2018-14-04
    Observational study model:
    Ecologic or Community
    Time perspective:
    Retrospective
    Clinical publications:
    Gabriel Carrasquilla, Alexandra Porras, Sandra Martinez, Rodrigo DeAntonio, Raghavendra Devadiga, Diana C Caceres, Patricia Juliao. Incidence and mortality of pertussis disease in infants <12 months of age following introduction of pertussis maternal universal mass vaccination in Bogotá, Colombia. Vaccine. 2020 Oct 27;38(46):7384-7392. doi: 10.1016/j.vaccine.2020.07.046. Epub 2020 Oct 2.
    Medical condition
    Diphtheria, acellular pertussis, Tetanus, Aspergillosis, Allergic Bronchopulmonary, Diphtheria-Tetanus-acellular Pertussis Vaccines
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    October 2015 to April 2018
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    0 days - 12 months
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bogota, Colombia, 110111
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2018-14-04
    Actual study completion date
    2018-14-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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