A Study to Assess the Impact of Pneumococcal Conjugate Va... | NCT01040143

Studies
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci

NCT01040143

Sponsor

Public Health England

Status

Completed

Last Update Posted

Mar 22, 2019Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Pneumococcal Disease

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Dec 28, 2009

First Submission Date that Met QC Criteria

Dec 28, 2009

First Posted Date

Dec 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2019

Last Update Posted Date

Mar 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Measure	Description	Time Frame
Presence of pneumococci in nasopharyngeal swabs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled
Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or
Written informed consent given by the subject after the nature of the study has been explained to them

Exclusion Criteria:

Moderate to severe disability.
Cerebral palsy, syndromes and neurological disorders affecting swallowing.
Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears.
Confirmed or suspected immunodeficiency (congenital or acquired).
On immunosuppressive therapy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Community samples taken within the home of eligible subjects.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Protection Agency		Stevenage	Hertfordshire		United Kingdom
Health Protection Agency

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24657717	Result	van Hoek AJ, Sheppard CL, Andrews NJ, Waight PA, Slack MP, Harrison TG, Ladhani SN, Miller E. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine. 2014 Jul 23;32(34):4349-55. doi: 10.1016/j.vaccine.2014.03.017. Epub 2014 Mar 21.

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses