Streptococcus Pneumoniae InfectionNCT03102840
Understanding Pneumococcal Carriage and Disease 2017-2020
An observational study of Streptococcus Pneumoniae Infection and Streptococcus Pneumoniae, Invasive Disease, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae Infection, Streptococcus Pneumoniae, Invasive Disease, Streptococcal Pneumonia
- What is being tested?
- Nasopharyngeal swab and blood sampling
- How many people
- 2,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jun 2017to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- Temporary exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Cross-sectional Study to Establish the Point Prevalence of Serotype 19A Pneumococcal Nasopharyngeal Carriage of Fully Vaccinated Children Aged 6-48 Months 7 Years Following Introduction of PCV-13
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.
Read more
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.
Read the detailed description
This is a cross sectional observational study to determine the point prevalence of pneumococcal carriage in children. In this study up to 1600, healthy children aged 13-48 months who have received a complete course of PCV13 at least one month prior to study enrolment, will be recruited. In addition, up to 800, 6-12 month old children who have received a priming dose of PCV13 will be recruited.
For the 13-48 month cohort, an interim analysis for futility to demonstrate an increase in serotype 19A will be performed after the first 750 participants.
The study will be carried out in the Thames Valley and South Midlands. Parents/legal guardians will be approached either by website based advertisements, social media, poster advertisements and emailing and/or handing out information booklets through their child's nurseries, GP Surgeries and educational/play settings. The investigators may also identify potential participants by mailing out invitation letters and leaflets to age appropriate children via the Open Exeter system of National Health Application and Infrastructure Services, the Child Health Computer Department, equivalent NHS database or through the Clinical Research Network. Parents/legal guardians of potential participants who have expressed interest will be directed to the Oxford Vaccine group (OVG) website where they will be able to access the participant information booklet and if appropriate complete online self-screening. If parents approach OVG to express interest, the information booklet will be sent to them and they may be telephone screened.
This study will involve a one off visit. The study visit will be arranged to occur in a convenient venues such as: hospital out patients, university clinic rooms, village halls, church halls, nurseries, participant's homes, sporting and recreational areas, GP practices and other similar venues where pre-school children frequently attend. Permission would be seek from the above venues to carry out any study procedures on their premises. Pre-arranged dates and times will be offered to parents/legal guardians by online booking, phone call or email.
During the visit the investigators would go through the details of the study and provide an opportunity for further questions. For those willing to proceed the investigators would then ask participants to sign a consent form and collect demographic information. A nasopharyngeal swab will be taken, and if consented to do so an optional blood sample will be performed in a subset of 632 participants. No further visits or follow-up will be required.
- Conditions
- Streptococcus Pneumoniae Infection, Streptococcus Pneumoniae, Invasive Disease, Streptococcal Pneumonia
- Being tested
- Nasopharyngeal swab, blood sampling
- Keywords
- Carriage, Immunogenicity, Pneumococcal conjugate vaccine 13 (PCV 13), Children, Pneumococcus
- Medical subject headings
- Pneumococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabDiagnostic test
Nasopharyngeal swab will be performed in all participants
blood samplingDiagnostic test
Blood sampling will be done by finger-prick in a sub-set of participants
| Study group | Role | What they receive |
|---|---|---|
| Children nasal swab only | Pneumococcal nasopharyngeal carriage in children aged 6-48 months who have previously received PCV13 Receives: Diagnostic Test: Nasopharyngeal swab | |
| Children nasal swab + serum | Pneumococcal nasopharyngeal carriage and immunogenicity in children aged 6-48 months who have previously received PCV13 Receives: Diagnostic Test: Nasopharyngeal swab; Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Presence of PCV13 vaccine type pneumococcal serotypes NP swab samples by microarray analysis
Measured: 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
Presence of PCV13 non-vaccine type pneumococcal serotypes on NP swab samples by microarray analysis
Measured: 3 years
To determine PCV-13 serotype specific anti-pneumococcus antibody concentrations in fully immunised 6 to 48 month old children
Antibody concentration by ELISA (finger-prick blood sample) for PCV13 vaccine-types
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start26 Jun 2017
- Primary completion30 Apr 2020
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Streptococcus Pneumoniae InfectionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102840
- Sponsor's protocol ID
- OVG 2017/03
- Status last verified
- Oct 2020
- First submitted
- 30 Mar 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36130327
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study to Establish the Point Prevalence of Serotype 19A Pneumococcal Nasopharyngeal Carriage of Fully Vaccinated Children Aged 6-48 Months 7 Years Following Introduction of PCV-13
- ClinicalTrials.gov ID
- NCT03102840
- Acronym / sponsor ID
- OVG 2017/03
- Conditions
- Streptococcus Pneumoniae Infection, Streptococcus Pneumoniae, Invasive Disease, Streptococcal Pneumonia
- Keywords
- Carriage, Immunogenicity, Pneumococcal conjugate vaccine 13 (PCV 13), Children, Pneumococcus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cross sectional observational study to determine the point prevalence of pneumococcal carriage in children. In this study up to 1600, healthy children aged 13-48 months who have received a complete course of PCV13 at least one month prior to study enrolment, will be recruited. In addition, up to 800, 6-12 month old children who have received a priming dose of PCV13 will be recruited.
For the 13-48 month cohort, an interim analysis for futility to demonstrate an increase in serotype 19A will be performed after the first 750 participants.
The study will be carried out in the Thames Valley and South Midlands. Parents/legal guardians will be approached either by website based advertisements, social media, poster advertisements and emailing and/or handing out information booklets through their child's nurseries, GP Surgeries and educational/play settings. The investigators may also identify potential participants by mailing out invitation letters and leaflets to age appropriate children via the Open Exeter system of National Health Application and Infrastructure Services, the Child Health Computer Department, equivalent NHS database or through the Clinical Research Network. Parents/legal guardians of potential participants who have expressed interest will be directed to the Oxford Vaccine group (OVG) website where they will be able to access the participant information booklet and if appropriate complete online self-screening. If parents approach OVG to express interest, the information booklet will be sent to them and they may be telephone screened.
This study will involve a one off visit. The study visit will be arranged to occur in a convenient venues such as: hospital out patients, university clinic rooms, village halls, church halls, nurseries, participant's homes, sporting and recreational areas, GP practices and other similar venues where pre-school children frequently attend. Permission would be seek from the above venues to carry out any study procedures on their premises. Pre-arranged dates and times will be offered to parents/legal guardians by online booking, phone call or email.
During the visit the investigators would go through the details of the study and provide an opportunity for further questions. For those willing to proceed the investigators would then ask participants to sign a consent form and collect demographic information. A nasopharyngeal swab will be taken, and if consented to do so an optional blood sample will be performed in a subset of 632 participants. No further visits or follow-up will be required.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children nasal swab only | – | Diagnostic Test: Nasopharyngeal swabPneumococcal nasopharyngeal carriage in children aged 6-48 months who have previously received PCV13 |
| Children nasal swab + serum | – | Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: blood samplingPneumococcal nasopharyngeal carriage and immunogenicity in children aged 6-48 months who have previously received PCV13 |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swabNasopharyngeal swab will be performed in all participants | Diagnostic test | Children nasal swab + serum, Children nasal swab only |
| blood samplingBlood sampling will be done by finger-prick in a sub-set of participants | Diagnostic test | Children nasal swab + serum |
Primary outcome
Serotype 19A-specific carriage rate in healthy children aged 6 to 48 months in 2017-2020.
Time frame: 3 year
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 secondary outcomes
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
Time frame: 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
Time frame: 3 years
To determine PCV-13 serotype specific anti-pneumococcus antibody concentrations in fully immunised 6 to 48 month old children
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Derived from this study: PubMed 36130327Tiley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Infection and Streptococcus Pneumoniae, Invasive Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotype 19A-specific carriage rate in healthy children aged 6 to 48 months in 2017-2020. (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.