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

NCT02569879 | Completed

• 1 other identifier: 201521
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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

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

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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

Pertussis maternal immunization OTHER

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

Infants Group; Pregnant women Group

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bogotá, 110111, Colombia

Location

Related 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.

  PMID: 33012607 BACKGROUND

MeSH Terms

Conditions

Diphtheria; Tetanus; Aspergillosis, Allergic Bronchopulmonary; Whooping Cough

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bordetella Infections; Gram-Negative Bacterial Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: April 14, 2018
• Study Completion: April 14, 2018
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)