Last updated: 02/20/2024 09:10:12

Trends in incidence of radiograph-confirmed likely bacterial pneumonia hospital admissions in children aged < 2 years in Poland pre- and post- universal mass vaccination with Synflorix

GSK study ID

208789

See study documents

Clinicaltrials.gov ID

Not applicable

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: A retrospective observational study of trends in the incidence of radiograph-confirmed likely bacterial pneumonia hospital admissions in children aged <2 years in Poland pre- and post- universal mass vaccination with Synflorix.

Trial description: The purpose of this study is to describe trends in the incidence of radiograph-confirmed likely bacterial pneumonia hospital admissions in children aged <2 years in Poland pre-(2013–2016) and post-(2017–2018) introduction of the Universal Mass Vaccination (UMV) program.

Primary purpose:

Other

Trial design:

Not applicable

Masking:

Not applicable

Allocation:

Not applicable

Primary outcomes:

Incidence rates of radiograph-confirmed likely bacterial pneumonia related hospital admissions in children aged <2 years by year and region

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Estimates of the change in incidence rate of radiograph-confirmed likely bacterial pneumonia related hospital admissions in children aged <2 years

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Percentage change and estimated effect in incidence rate of radiograph-confirmed likely bacterial pneumonia related hospital admissions in children aged <2 years

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Secondary outcomes:

Incidence rates of hospital admissions coded for bacterial pneumonias in children aged <2 years by year and region

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Percentage change and estimated effect in incidence rate of hospital admissions coded for bacterial pneumonias in children aged <2 years

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Incidence rates of hospital admissions coded for viral pneumonias in children aged <2 years by year and region

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Percentage change and estimated effect in incidence rate of hospital admissions coded for viral pneumonias in children aged <2 years

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Incidence rates of hospital admissions coded for all-cause pneumonias in children aged <2 years by year and region

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Percentage change and estimated effect in incidence rate of hospital admissions coded for all-cause pneumonias in children aged <2 years

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Incidence rates of hospital admissions for radiograph-confirmed likely non-bacterial pneumonias in children aged <2 years by year and region

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Percentage change and estimated effect in incidence rate of hospital admissions for radiograph-confirmed likely non-bacterial pneumonias in children aged <2 years

Timeframe: During pre- (2013–2016) and post- (2017–2018) introduction of the GSK1024850A (10Pn) UMV program

Interventions:

Not applicable

Enrollment:

1

Primary completion date:

2021-05-01

Observational study model:

Cohort

Time perspective:

Retrospective

Clinical publications:

Bhavsar A, Zaryczański J, Wasilewska A, Saragoussi D, Devadiga R, Colby C, Bahar E, Wysocki J. Pneumonia hospitalizations of children aged <2 years in Poland before (2013–2016) and after (2017–2018) universal mass vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine. Hum Vaccin Immunother. 2022;2128566. DOI: http://dx.doi.org/ 10.1080/21645515.2022.2128566

Medical condition

Streptococcus pneumoniae

Product

GSK1024850A

Collaborators

Not applicable

Study date(s)

May 2019 to March 2021

Type

Observational

Phase

Not applicable

Participation criteria

Sex

Female & Male

Age

0 - 23 Months

Accepts healthy volunteers

No

Children < 2 years of age (that is up to 23 months of age) at admission
With a hospitalisation record in the hospital EMRs of interest

Not applicable

Trial location(s)

Location

Status

Contact us

Location

GSK Investigational Site

Bialystok, Poland, 15-274

Status

Study Complete

Location

GSK Investigational Site

Opole, Poland, 45-401

Status

Study Complete

Study documents

Study report synopsis

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

2021-05-01

Actual study completion date

2021-02-03

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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