- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01808365
N. Meningitidis Carriage Study
March 8, 2018 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1000
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
-
-
-
Manila, Philippines
- GSK Investigational Site
-
-
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
Ages Eligible for Study
5 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
Intervention / Treatment |
---|---|
Study cohort
|
Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.
Other Names:
Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
Time Frame: At enrollment (Day 0)
|
At enrollment (Day 0)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies
Time Frame: At enrollment (Day 0)
|
At enrollment (Day 0)
|
Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing
Time Frame: At enrollment (Day 0)
|
At enrollment (Day 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
August 2, 2013
Primary Completion (Actual)
March 25, 2014
Study Completion (Actual)
March 25, 2014
Study Registration Dates
First Submitted
March 7, 2013
First Submitted That Met QC Criteria
March 7, 2013
First Posted (Estimate)
March 11, 2013
Study Record Updates
Last Update Posted (Actual)
March 9, 2018
Last Update Submitted That Met QC Criteria
March 8, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
-
Statistical Analysis Plan
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 114991Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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.
Clinical Trials on Infections, Meningococcal
-
Prof. Elizabeth MillerNovartis VaccinesCompletedMeningococcal Meningitis, Serogroup A | Meningococcal Meningitis, Serogroup B | Meningococcal Meningitis, Serogroup C | Meningococcal Meningitis, Serogroup Y | Meningococcal Meningitis, Serogroup WUnited Kingdom
-
Chiron CorporationUnknownMeningococcal Disease; Meningococcal MeningitisUnited Kingdom
-
EuBiologics Co.,LtdCompletedInfection, MeningococcalKorea, Republic of
-
GlaxoSmithKlineCompletedInfections, Meningococcal | Meningococcal VaccinesEstonia, Germany, Spain
-
EuBiologics Co.,LtdCompletedInfection, MeningococcalKorea, Republic of
-
GlaxoSmithKlineCompletedInfections, Meningococcal | Meningococcal VaccinesIndia, Lebanon, Philippines, Saudi Arabia
-
GlaxoSmithKlineCompletedMeningococcal Disease | Infections, MeningococcalColombia, Panama, Chile
-
GlaxoSmithKlineCompletedMeningococcal Disease | Infections, MeningococcalUnited States
-
GlaxoSmithKlineCompletedInfections, Meningococcal | Meningococcal VaccinesGermany, France
-
GlaxoSmithKlineCompletedMeningococcal Disease | Infections, MeningococcalUnited States
Clinical Trials on Posterior pharyngeal swab
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Assistance Publique Hopitaux De MarseilleUnknownMeningo-encephalitis | Community-based MeningitisFrance
-
French National Agency for Research on AIDS and...CompletedHIV Infections | InfluenzaFrance
-
Wissenschaftliches Institut Bethanien e.VCompleted
-
Assistance Publique Hopitaux De MarseilleCompletedAcute Respiratory InfectionFrance
-
Centre Hospitalier Universitaire VaudoisCompletedLower Resp Tract InfectionSwitzerland
-
University Children's Hospital, ZurichCompletedDiagnosis | Childhood Pneumonia | Mycoplasma Pneumonia | Antibody-secreting Cells | Enzyme-linked Immunospot (ELISpot)
-
Medical College of WisconsinRecruiting
-
Newcastle-upon-Tyne Hospitals NHS TrustUnknownRespiratory Distress Syndrome in Premature Infants | Extreme Prematurity - Less Than 28 WeeksUnited Kingdom