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Neisseria Meningitidis Burden of Disease Study

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 15, 2012
Last updated: November 9, 2015
Last verified: November 2015
This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.

Condition Intervention
Streptococcus Pneumoniae Neisseria Meningitidis Haemophilus Influenzae Other: Data collection Other: CSF samples testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Neisseria Meningitidis Burden of Disease

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prevalence of N. meningitis in CSF samples [ Time Frame: At enrollment (Day 0) ]
  • Serogroup of N. meningitis positive samples [ Time Frame: At enrollment (Day 0) ]

Secondary Outcome Measures:
  • Further characterization of N. meningitidis using Multi Locus Sequence Typing [ Time Frame: At enrollment (Day 0) ]
  • Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis [ Time Frame: At enrollment (Day 0) ]
  • Serotype of Streptococcus pneumoniae positive samples [ Time Frame: At enrollment (Day 0) ]
  • Further classification of Haemophilus influenzae positive samples into Type B and non-B Types [ Time Frame: At enrollment (Day 0) ]
  • Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition) [ Time Frame: At enrollment (Day 0) ]

Biospecimen Retention:   Samples Without DNA
Cerebrospinal Fluid (CSF) sample (collected as part of routine practice)

Enrollment: 521
Study Start Date: January 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study cohort
Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.
Other: Data collection
Collection of demographic data and vaccination history
Other: CSF samples testing
CSF samples will be tested for the determination of N. meningitidis and other likely bacterial pathogens that cause bacterial meningitis (S. pneumoniae and H. influenzae)


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.

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.
  • A male or female subject who visits the hospital with suspected bacterial meningitis.
  • CSF sample taken as part of routine practice.

Exclusion Criteria:

  • Child in care.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01730391

GSK Investigational Site
Baguio City, Benguet, Philippines, 2600
GSK Investigational Site
Quezon City, Philippines, 1102
GSK Investigational Site
Hanoi, Vietnam, 084
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01730391     History of Changes
Other Study ID Numbers: 114989
Study First Received: November 15, 2012
Last Updated: November 9, 2015

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on September 20, 2017