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Completed

NCT Number: NCT02569879

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

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.

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Key information

Conditions

Diphtheria Acellular Pertussis Actinomycetales Infections Aspergillosis Aspergillosis, Allergic Bronchopulmonary Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Diphtheria-Tetanus-acellular Pertussis Vaccines Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Fungal Mycoses Pulmonary Aspergillosis Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

0 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Bogotá, 110111, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pertussis maternal immunization

Other

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

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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2015
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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