A Study to Assess the Carriage of Pneumococci in Children Aged ≤8 Years, and Their Household Contacts (PIN2)

August 27, 2019 updated by: Public Health England

Since the introduction of pneumococcal conjugate vaccines, this research group has conducted several carriage studies. These were at key points in the evolution of the pneumococcal immunisation schedule, with regard to the introduction of PCV7, the change to PCV13 and the impending change in number of doses of PCV13 given to infants. The last carriage study, conducted in 2015/16 identified interesting changes in carriage patterns which will further be explored by the current planned study.

Nasopharyngeal swabs and saliva swabs will be taken from healthy subjects and any pneumococci present will be cultured and serotyped using standard methods, as per our previous studies (Hussain et al., 2005; Flasche et al., 2011; van Hoek et al., 2014).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Streptococcus pneumoniae frequently colonises the human nasopharynx and most carriers remain asymptomatic. However, sometimes the organism may spread locally to cause non-invasive, mucosal infections such as sinusitis and otitis media or may invade the bloodstream and cause serious infections, including septicaemia, meningitis and pneumonia. In the 2005/06 epidemiological year, there were 6,391 cases of invasive pneumococcal diseases in England and Wales, with the highest incidence in the first year of life. The risk of developing invasive disease is dependent on both the susceptibility of the host and the invasiveness of the pneumococcus, which is largely determined by the characteristics of its polysaccharide capsule. Of the >90 known pneumococcal serotypes, the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in the 7-valent pneumococcal conjugate vaccine (PCV7) accounted for around 75% of childhood IPD cases in England and Wales prior to routine pneumococcal vaccination.

There have been several carriage studies conducted by this group at key points in the evolution of the pneumococcal vaccination policy of the UK, before use of any PCV, once the PCV7 had been introduced and once the change to PCV13 had been made. Studies have shown that conjugate vaccines, of which PCV7 and PCV13 are examples, can affect carriage of the bacteria against which the vaccinate. This series of carriage studies is important in understanding which pneumococcal strains are in the nose and so are potentially part of the chain of transmission as the vaccinations given have changed. For pneumococcus, where there are many strains, it is important to understand whether clearing carriage of a strain contained in the vaccine creates a niche which can be exploited by a strain of greater virulence or one which causes more serious disease. Our last such study suggested there are changes which we should continue to monitor, which is why the current study is now happening.

Nasopharyngeal swabs and saliva swabs will be taken from healthy subjects and any pneumococci present will be cultured and serotyped using standard methods, as per our previous studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom
        • Gloucestershire Primary Care
    • Hertfordshire
      • Hertford, Hertfordshire, United Kingdom
        • Hertfordshire primary care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

• At least 200 children (index cases) aged ≤8 years and at least 200 household contacts.

Description

Inclusion Criteria:

  1. At least one child aged ≤8 years in the household
  2. Written informed consent obtained from the child's parent / legal guardian for their participation, and for any participating household contacts

Exclusion Criteria:

  • Moderate to severe cerebral palsy or other debilitating condition
  • Syndromes and neurological disorders affecting swallowing.
  • Ear, nose & throat disorders affecting local anatomy for swabbing (e.g. malformed ears)
  • Confirmed or suspected immunodeficiency (congenital or acquired) or receiving immunosuppressive therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PIN2 study participants
All those giving swabs for the study
Other: nasal swab
collection of nasal swab to allow carriage of pneumococci to be assessed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pneumococcal carriage rates
Time Frame: through study completion, expected 6 months
pneumococcal carriage rates for PCV13 and non-PCV13 serotypes in children and infants eligible for primary or booster immunisation with PCV 13 and their household contacts
through study completion, expected 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Public Health England

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elizabeth Coates, PhD, Public Health England

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIN2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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