## Protocol Section
### Identification Module
**NCT ID:** NCT02569879

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

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

#### Organization Study ID Info
**ID:** 201521
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2018-04-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-04-14

**Type:** ACTUAL

#### Start Date
**Date:** 2015-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2015-10-07
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-01
**Study First Submit QC Date:** 2015-10-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Diphtheria

- Acellular Pertussis

- Tetanus

- Aspergillosis, Allergic Bronchopulmonary

- Diphtheria-Tetanus-acellular Pertussis Vaccines

**Keywords:**

- Boostrix™

- Bagota

- maternal vaccination

- Pertussis

- Mortality

- Morbidity

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** * 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.

**Intervention Names:**

- Other: Pertussis maternal immunization

**Label:** Infants Group

#### Arm Group 2

**Description:** • Pregnant women will be included in the study to assess the vaccination coverage of Boostrix from March 2013 to December 2014

**Intervention Names:**

- Other: Pertussis maternal immunization

**Label:** Pregnant women Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Infants Group

- Pregnant women Group

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

**Name:** Pertussis maternal immunization

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

**Measure:** 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)

**Measure:** 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)

**Measure:** 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)

**Measure:** 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)

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 12 Months

**Minimum Age:** 0 Days

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bogota

**Country:** Colombia

**Facility:** GSK Investigational Site

**Zip:** 110111

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001885

- Term: Bordetella Infections

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000003015

- Term: Clostridium Infections

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006996

- Term: Hypocalcemia

- ID: D000002128

- Term: Calcium Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000003354

- Term: Corynebacterium Infections

- ID: D000000193

- Term: Actinomycetales Infections

- ID: D000009181

- Term: Mycoses

- ID: D000055732

- Term: Pulmonary Aspergillosis

- ID: D000008172

- Term: Lung Diseases, Fungal

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7347

- Name: Diphtheria

- Relevance: HIGH

- As Found: Diphtheria

- ID: M17656

- Name: Whooping Cough

- Relevance: HIGH

- As Found: Pertussis

- ID: M4535

- Name: Aspergillosis

- Relevance: HIGH

- As Found: Aspergillosis

- ID: M16511

- Name: Tetanus

- Relevance: HIGH

- As Found: Tetanus

- ID: M16515

- Name: Tetany

- Relevance: HIGH

- As Found: Tetanus

- ID: M4536

- Name: Aspergillosis, Allergic Bronchopulmonary

- Relevance: HIGH

- As Found: Aspergillosis, Allergic Bronchopulmonary

- ID: M6590

- Name: Cough

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5163

- Name: Bordetella Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19249

- Name: Gram-Negative Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6247

- Name: Clostridium Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19252

- Name: Gram-Positive Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M10046

- Name: Hypocalcemia

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5391

- Name: Calcium Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6574

- Name: Corynebacterium Infections

- Relevance: LOW

- As Found: Unknown

- ID: M28314

- Name: Pulmonary Aspergillosis

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11169

- Name: Lung Diseases, Fungal

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1885

- Name: Diphtheria

- Relevance: HIGH

- As Found: Diphtheria

- ID: T5926

- Name: Whooping Cough

- Relevance: HIGH

- As Found: Pertussis

- ID: T511

- Name: Aspergillosis

- Relevance: HIGH

- As Found: Aspergillosis

- ID: T5607

- Name: Tetanus

- Relevance: HIGH

- As Found: Tetanus

- ID: T286

- Name: Allergic Bronchopulmonary Aspergillosis

- Relevance: HIGH

- As Found: Aspergillosis, Allergic Bronchopulmonary

### Condition Browse Module - Meshes

- ID: D000014917

- Term: Whooping Cough

- ID: D000013742

- Term: Tetanus

- ID: D000004165

- Term: Diphtheria

- ID: D000001228

- Term: Aspergillosis

- ID: D000001229

- Term: Aspergillosis, Allergic Bronchopulmonary

- ID: D000013746

- Term: Tetany

### Misc Info Module

- Version Holder: 2024-05-24
