MeningitisNCT01996007
Understanding Pneumococcal Carriage and Disease
An observational study of Meningitis and Septicaemia, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle ear infections), blood poisoning, and meningitis. It is frequently carried by people in back of the throat without symptoms. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Septicaemia, Pneumonia
- How many people
- 1,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Aug 2015
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: One thousand healthy children aged 6-48 months, of which at least 600 will be aged 21-48 months, who have received 3 doses of PCV13 will be recruited along with a subset (200) of their parents/legal guardians
Who may be able to join
- Children
- 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
- Have received three doses of PCV13 as per infant immunisation schedule (as confirmed by red book or through vaccination history and age). Vaccination history will be 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 subsequently excluded if they are found to not have received all three doses of PCV13.Aged 6-48 months and at least 28 days since their third PCV13 vaccination.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Parents/ Legal guardians
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- Participant is willing and able to give informed consent for participation in the study.
- Is the child's legal guardian and lives in the same household with the child participating in the same study.
- In good health as determined by clinical judgement of the research staff
- Able (in the investigators opinion) and willing to comply with all study requirements.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Children
- 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 are unimmunised or have an incomplete course of PCV13.
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- 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.
- Febrile illness or temperature of 38°C 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.
- A risk of nose bleed, including; a recent (within the last 24 hours) nose bleed, history of a bleeding disorder, history of severe nose bleeds 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.
- Parents/ Legal guardians
- Participants who are unwilling or unable to give written informed consent to participate in the study.
- Less than 18 years of age at time of enrolment
- Is listed on the study delegation log
- Previous immunisation with pneumococcal conjugate vaccine.
- Participants who in the opinion of the investigator are unable to comply with study procedures or may be put at risk by participation in the study.
- Febrile illness or temperature of 38°C 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.
- A risk of nose bleed, including; a recent (within the last 24 hours) nose bleed, history of a bleeding disorder, a history of severe nose bleeds 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.
About this study
Official title: Cross-sectional Study to Establish the Point Prevalence of Serotype 19A Pneumococcal Nasopharyngeal Carriage of Fully Vaccinated Children Aged 13-48 Months Following Introduction of PCV13.
Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle ear infections), blood poisoning, and meningitis. It is frequently carried by people in back of the throat without symptoms. Pneumococcal carriage in the Thames Valley region has been studied over the last 12 years with carriage rates having been shown to be reflective of disease potential and hence vaccine effect. During this time pneumococcal vaccines have been introduced into the routine immunisation schedules of this community. The PCV7 (A vaccine against 7 types of pneumococcus) vaccine has subsequently been noted to have had a significant impact in reducing vaccine serotype carriage and disease. Herd protection (indirect protection of unvaccinated individuals) has also been implicated with vaccine serotypes not being carried in parents of vaccinated children. The most common serotype carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine immunisation schedule, however its impact on carriage and disease in this community is yet to be evaluated.
- Conditions
- Meningitis, Septicaemia, Pneumonia
- Keywords
- Pneumococcus, Carriage, Children, Parents, Immunogenicity, PCV13
- Medical subject headings
- Meningitis, Toxemia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Pneumococcal nasopharyngeal carriage and immunogenicity in children aged 6-48 months who have previously received PCV13 | |
| Parents | Pneumococcal nasopharyngeal carriage and immunogenicity in parents of children also participating in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of serotype 19A pneumococci on children's swabs
Measured: 2 years
Secondary outcomes (5)
The presence of pneumococcal serotypes on children's swabs
Measured: 2 years
The presence of pneumococcal serotypes on parents/legal guardians swabs
Measured: 2 years
The molecular sequence type of nasopharyngeal carriage isolates from children and parents/legal guardians.
Measured: 2 years
The serotype-specific and genotype-specific invasive disease potential of isolates recovered from children.
Measured: 2 years
The serotype specific pneumococcal antibodies levels in children and their parents/legal guardians
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
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 MeningitisStudies 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
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrew J Pollard, PhD, Principal investigator, Oxford Vaccine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996007
- Sponsor's protocol ID
- OVG 2013/05
- Status last verified
- Nov 2015
- First submitted
- 21 Nov 2013
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kandasamy R, Voysey M, Collins S, Berbers G, Robinson H, Noel I, Hughes H, Ndimah S, Gould K, Fry N, Sheppard C, Ladhani S, Snape MD, Hinds J, Pollard AJ. Persistent Circulation of Vaccine Serotypes and Serotype Replacement After 5 Years of Infant Immunization With 13-Valent Pneumococcal Conjugate Vaccine in the United Kingdom. J Infect Dis. 2020 Mar 28;221(8):1361-1370. doi: 10.1093/infdis/jiz178.
PubMed 31004136
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. 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 13-48 Months Following Introduction of PCV13.
- ClinicalTrials.gov ID
- NCT01996007
- Acronym / sponsor ID
- OVG 2013/05
- Conditions
- Meningitis, Septicaemia, Pneumonia
- Keywords
- Pneumococcus, Carriage, Children, Parents, Immunogenicity, PCV13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Nov 2013 (estimated)
- 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.
Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle ear infections), blood poisoning, and meningitis. It is frequently carried by people in back of the throat without symptoms. Pneumococcal carriage in the Thames Valley region has been studied over the last 12 years with carriage rates having been shown to be reflective of disease potential and hence vaccine effect. During this time pneumococcal vaccines have been introduced into the routine immunisation schedules of this community. The PCV7 (A vaccine against 7 types of pneumococcus) vaccine has subsequently been noted to have had a significant impact in reducing vaccine serotype carriage and disease. Herd protection (indirect protection of unvaccinated individuals) has also been implicated with vaccine serotypes not being carried in parents of vaccinated children. The most common serotype carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine immunisation schedule, however its impact on carriage and disease in this community is yet to be evaluated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Pneumococcal nasopharyngeal carriage and immunogenicity in children aged 6-48 months who have previously received PCV13 |
| Parents | – | –Pneumococcal nasopharyngeal carriage and immunogenicity in parents of children also participating in the study |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One thousand healthy children aged 6-48 months, of which at least 600 will be aged 21-48 months, who have received 3 doses of PCV13 will be recruited along with a subset (200) of their parents/legal guardians
Key inclusion criteria (10 listed)
- Children
- 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
- Have received three doses of PCV13 as per infant immunisation schedule (as confirmed by red book or through vaccination history and age). Vaccination history will be 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 subsequently excluded if they are found to not have received all three doses of PCV13.Aged 6-48 months and at least 28 days since their third PCV13 vaccination.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
Key exclusion criteria (23 listed)
- Children
- 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 are unimmunised or have an incomplete course of PCV13.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence of serotype 19A pneumococci on children's swabs
Time frame: 2 years
5 secondary outcomes
The presence of pneumococcal serotypes on children's swabs
Time frame: 2 years
The presence of pneumococcal serotypes on parents/legal guardians swabs
Time frame: 2 years
The molecular sequence type of nasopharyngeal carriage isolates from children and parents/legal guardians.
Time frame: 2 years
The serotype-specific and genotype-specific invasive disease potential of isolates recovered from children.
Time frame: 2 years
The serotype specific pneumococcal antibodies levels in children and their parents/legal guardians
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Results publication: PubMed 31004136Kandasamy R, Voysey M, Collins S, Berbers G, Robinson H, Noel I, Hughes H, Ndimah S, Gould K, Fry N, Sheppard C, Ladhani S, Snape MD, Hinds J, Pollard AJ. Persistent Circulation of Vaccine Serotypes and Serotype Replacement After 5 Years of Infant Immunization With 13-Valent Pneumococcal Conjugate Vaccine in the United Kingdom. J Infect Dis. 2020 Mar 28;221(8):1361-1370. doi: 10.1093/infdis/jiz178.
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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.
Andrew J Pollard, PhD principal investigator
Oxford Vaccine Group
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 Meningitis and Septicaemia, 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 10 inclusion and 23 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: finished, as of the sponsor's last update on 8 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The presence of serotype 19A pneumococci on children's swabs (time frame: 2 years). 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 NCT01996007, 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 8 Jul 2019.