NCT03102840

Brief Summary

Streptococcus pneumoniae is a type of bacteria that is carried (lives) in the nose of most individuals and can sometimes go on to cause severe infections such as meningitis and pneumonia. There are over 100 types of pneumococcus, and children in the UK have been routinely immunized against pneumococcal disease since 2006. A vaccine against 13 types of pneumococcus (PCV 13) was introduced into the UK in 2010, replacing a previous version that prevented 7 types. Pneumococcal carriage in the Thames Valley region has been studied over the last 7 years with carriage rates having been shown to be reflective of potential severe pneumococcal disease and hence vaccine effect. The main purpose of this study is to see whether the pneumococcal immunization program has changed the frequency and nature of pneumococcal bacteria carried by children, as this may give a clue as to what changes in pneumococcal disease are likely to be seen in the future. In addition, this study is especially timely given the possibility of a change in the PCV 13 immunization schedule that is currently being assessed in the 'Sched3' Immunization study (NCT02482636). Obtaining accurate baseline data will be important in informing the interpretation of any subsequent data on carriage rates obtained following introduction of the new schedule. This study will enrol up to 1600 children aged 13 to 48 months living in the Thames Valley and South Midlands and which have had three doses of 13-valent pneumococcal conjugate vaccine. In addition, up to 800, 6-12 month old children who have received a priming dose of PCV13 will be recruited. The study consists of one visit done at a convenient venue (GP surgeries, educational/ play settings, or home) where a single nasal swab and an optional finger-prick blood sample for a sub-set of 632 participants, will be performed. No additional follow-up is needed. The study recruitment period will be from 2017 onwards.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.8 years

First QC Date

March 30, 2017

Last Update Submit

October 19, 2020

Conditions

Streptococcus Pneumoniae InfectionStreptococcus Pneumoniae, Invasive DiseaseStreptococcal Pneumonia

Keywords

CarriageImmunogenicityPneumococcal conjugate vaccine 13 (PCV 13)ChildrenPneumococcus

Outcome Measures

Primary Outcomes (1)

  • Serotype 19A-specific carriage rate in healthy children aged 6 to 48 months in 2017-2020.

    To determine the serotype 19A-specific carriage rate in healthy children aged 6 to 48 months in 2017-2020, seven years following introduction of PCV13 and to compare this to carriage rates observed in 2014/2015 (OVG 2013/05 study).

    3 year

Secondary Outcomes (3)

  • To determine the PCV13 vaccine-type pneumococcal serotype-specific nasopharyngeal (NP) carriage rate and serotype distribution in children aged 13 to 48 months who have received a full course of PCV13

    3 year

  • To determine the non-PCV vaccine type pneumococcal serotype-specific NP carriage rate and serotype distribution in children aged 6 to 12 months who have received a primary course of PCV13

    3 years

  • To determine PCV-13 serotype specific anti-pneumococcus antibody concentrations in fully immunised 6 to 48 month old children

    3 years

Other Outcomes (2)

  • To compare PCV-13 serotype specific anti-pneumococcal antibody concentrations in age matched, fully immunized 6 to 48 month old children to historical cohorts from the OVG 2013/05 study.

    3 years

  • To assess for carriage of multiple pneumococcal strains in participants in the current study and on stored samples from OVG 2013/05 study.

    3 years

Study Arms (2)

Children nasal swab only

Pneumococcal nasopharyngeal carriage in children aged 6-48 months who have previously received PCV13

Diagnostic Test: Nasopharyngeal swab

Children nasal swab + serum

Pneumococcal nasopharyngeal carriage and immunogenicity in children aged 6-48 months who have previously received PCV13

Diagnostic Test: Nasopharyngeal swabDiagnostic Test: blood sampling

Interventions

Nasopharyngeal swabDIAGNOSTIC_TEST

Nasopharyngeal swab will be performed in all participants

Children nasal swab + serumChildren nasal swab only
blood samplingDIAGNOSTIC_TEST

Blood sampling will be done by finger-prick in a sub-set of participants

Children nasal swab + serum

Eligibility Criteria

Age6 Months - 48 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

1600 children aged 13 to 48 months, who have received 3 doses of PCV13 800 children aged 6-12 months, who have recieved 2 doses of PCV13

You may qualify if:

  • Parent/guardian of participant is willing and able to give informed consent for participation in the study.
  • In good health as determined by a brief medical history and/or clinical judgement of the investigator.
  • For children aged 13-48months, they must have received three doses of PCV13 as per infant immunization schedule (as confirmed by red book or through vaccination history and age). For children aged 6-12months, they must have received 2 doses of PCV12 as per the infant immunisation schedule.
  • (Vaccination history is confirmed by the child's GP or CHCD. The visit and sampling may still proceed if the vaccination history has not been confirmed beforehand and the participant can be subsequently excluded if they were found to not have received all required doses of PCV13.)
  • Aged 13-48 months and at least 28 days since their third PCV13 vaccination or aged 6-12months and at least 28days since their second dose of PCV13.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.

You may not qualify if:

  • Parent/legal guardian unwilling or unable to give written informed consent to participate in the study.
  • Parent/legal guardian less than 18 years of age at time of enrolment.
  • Parent/legal guardian is listed on the study delegation log.
  • Children who were known to be un-immunized or have an incomplete course of PCV13.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • History of bleeding disorder.
  • Febrile illness or temperature of 38°C or above on the day of the visit or in the preceding 24 hours.
  • Respiratory illness on the day of the study visit or in the preceding 24 hours. A respiratory illness will be classified as a combination of at least two of the following symptoms: cough, sore throat, and runny nose.
  • Administration of antibiotics in the month prior to sampling.
  • History of an acute nose bleed (within the last 24 hours), or recent (within the last 3 months) nasal/craniofacial surgery.
  • Receipt of blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

  • Tiley KS, Ratcliffe H, Voysey M, Jefferies K, Sinclair G, Carr M, Colin-Jones R, Smith D, Bowman J, Hart T, Kandasamy R, Hinds J, Gould K, Berbers G, Tcherniaeva I, Robinson H, Plested E, Aley P, Snape MD. Nasopharyngeal Carriage of Pneumococcus in Children in England up to 10 Years After 13-Valent Pneumococcal Conjugate Vaccine Introduction: Persistence of Serotypes 3 and 19A and Emergence of 7C. J Infect Dis. 2023 Mar 1;227(5):610-621. doi: 10.1093/infdis/jiac376.

    PMID: 36130327DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacteria grown from nasopharyngeal swabs Serum to measure serotype specific antibodies levels

MeSH Terms

Conditions

Pneumococcal InfectionsPneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 6, 2017

Study Start

June 26, 2017

Primary Completion

April 30, 2020

Study Completion

October 31, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)