Infections, MeningococcalNCT01808365
N. Meningitidis Carriage Study
An observational study of Infections, Meningococcal, run by GlaxoSmithKline at 1 site in Philippines.
Trial summary
This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population. Read more about this study
- Who is it for?
- Ages 5 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Posterior pharyngeal swab and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 sitePhilippines
- Study dates
- 2 Aug 2013to 25 Mar 2014
- 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 5 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
- Asymptomatic subjects attending a school or university.
- A male or female between, and including 5 and 24 years of age at the time of enrollment.
Who cannot join
- Subjects who have received a meningococcal conjugate vaccine.
- Use of any investigational or non-registered product within one week before the enrollment visit.
- Acute respiratory tract infection within 14 days of sample collection.
- Immune deficiencies, haematological disorders and oncological disease.
- Use of steroids or immunosuppressant drugs within 14 days of sample collection.
- Administration of antibiotics within the 2 weeks preceding the collection of sample.
- Cranio-facial malformations prohibiting the collection of posterior pharyngeal swabs.
- Child in care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neisseria Meningitidis Carriage Study
This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population.
- Conditions
- Infections, Meningococcal
- Being tested
- Posterior pharyngeal swab, Data collection
- Keywords
- Neisseria meningitidis, Philippines, carriage, meningococcus
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior pharyngeal swabProcedure or surgery
Also called Throat swab
Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.
Data collectionOther
Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Not described Receives: Procedure: Posterior pharyngeal swab; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
Measured: At enrollment (Day 0)
Secondary outcomes (2)
The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies
Measured: At enrollment (Day 0)
Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing
Measured: At enrollment (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study start2 Aug 2013
- Primary completion25 Mar 2014
- Study completion25 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808365
- Sponsor's protocol ID
- 114991
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2013
- Last updated
- 9 Mar 2018
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neisseria Meningitidis Carriage Study
- ClinicalTrials.gov ID
- NCT01808365
- Acronym / sponsor ID
- 114991
- Conditions
- Infections, Meningococcal
- Keywords
- Neisseria meningitidis, Philippines, carriage, meningococcus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2013 (actual)
- Primary completion
- 25 Mar 2014 (actual)
- Study completion
- 25 Mar 2014 (actual)
- First posted
- 11 Mar 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.
This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Procedure: Posterior pharyngeal swab, Other: Data collection |
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.
Key inclusion criteria (4 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
- Asymptomatic subjects attending a school or university.
- A male or female between, and including 5 and 24 years of age at the time of enrollment.
Key exclusion criteria (8 listed)
- Subjects who have received a meningococcal conjugate vaccine.
- Use of any investigational or non-registered product within one week before the enrollment visit.
- Acute respiratory tract infection within 14 days of sample collection.
- Immune deficiencies, haematological disorders and oncological disease.
- Use of steroids or immunosuppressant drugs within 14 days of sample collection.
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 |
|---|---|---|
| Posterior pharyngeal swabAlso: Throat swabPosterior pharyngeal swabs will be tested for the presence of N. meningitidis. | Procedure or surgery | Study cohort |
| Data collectionCollection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives. | Other | Study cohort |
Primary outcome
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
Time frame: At enrollment (Day 0)
2 secondary outcomes
The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies
Time frame: At enrollment (Day 0)
Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing
Time frame: At enrollment (Day 0)
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 9 Mar 2018.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Infections, Meningococcal, run by GlaxoSmithKline at 1 site in Philippines.
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 4 inclusion and 8 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 9 Mar 2018. 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 Philippines. 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?
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs (time frame: At enrollment (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2018.