NCT01040143

Brief Summary

A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 22, 2019

Status Verified

September 1, 2010

Enrollment Period

2.2 years

First QC Date

December 28, 2009

Last Update Submit

March 20, 2019

Conditions

Keywords

PneumococciStreptococcus pneumoniae

Outcome Measures

Primary Outcomes (1)

  • Presence of pneumococci in nasopharyngeal swabs

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community samples taken within the home of eligible subjects.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Health Protection Agency

Stevenage, Hertfordshire, United Kingdom

Location

Health Protection Agency

Gloucester, United Kingdom

Location

Health Protection Agency

London, NW9 5HT, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

January 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 22, 2019

Record last verified: 2010-09

Locations