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Trial record 23 of 579 for:    meningitis

A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate

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ClinicalTrials.gov Identifier: NCT02374450
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
AMP (Agency Preventive Medicine)
CLS (Second line laboratory support)
Quintiles, Inc.
Mobile Phone Alert System Provider (Epi-concept)
RAFT (Francophone Africa Network for Telemedicine)
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

The purpose of this pre-licensure cohort study is to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study will provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that will evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine.

An interim analysis will be performed when the RTS,S/AS01E vaccine will be implemented in most of the study sites. This interim analysis will be done with clean data collected on a sub-group of subjects having 6 months of follow-up following the administration of dose 3 of DTP/HepB/Hib vaccine (6 12 weeks group), or 6 months after Visit 3 (5-17 months group); corresponding to Visit 5. The interim analysis will concern primary safety endpoints and the main impact endpoints (at 6 months post last dose for the purpose of this interim).


Condition or disease Intervention/treatment Phase
Malaria Procedure: Lumbar puncture Procedure: Venous blood sample Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52192 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective Study to Estimate the Incidence of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Infants and Young Children in Sub-Saharan Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine
Actual Study Start Date : October 5, 2015
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Meningitis

Arm Intervention/treatment
Active and enhanced hospitalisation surveillance group
Children <18 months of age and living in the HDSS area (active surveillance group) and children <5 years of age and hospitalised at any time during the study, living in the HDSS area (enhanced hospitalisation surveillance group).
Procedure: Lumbar puncture
For all enrolled children, hospitalised and suspected of a neurological AESI or meningitis, where a cerebrospinal fluid (CSF) sample has been taken as part of routine practice, part of the CSF sample will be stored for this study (minimum 500 µL).

Procedure: Venous blood sample
Approximately 5 mL of whole blood will be collected from all enrolled children, hospitalised and suspected of having an AESI or meningitis, and the serum will be stored.




Primary Outcome Measures :
  1. Occurrence of AESI [ Time Frame: Enrolled children will be followed up through home visits for a total period of 44 months. ]
    Acute Disseminated Encephalomyelitis (ADEM), encephalitis, Guillain Barré Syndrome, hypotonic-hyporesponsive episode, generalised convulsive seizure. Intussusception, hepatic insufficiency, renal insufficiency. Intussusception, hepatic insufficiency, renal insufficiency. Juvenile chronic arthritis, Stephen-Johnson syndrome/toxic epidermal necrolysis, Henoch-Schonlein purpura, Kawasaki disease. Diabetes mellitus type I, thrombocytopenia, anaphylaxis.

  2. Occurrence of other AE leading to hospitalisation or death [ Time Frame: Day 0 to Month 44 ]
    AEs were assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.

  3. Occurrence of aetiology confirmed meningitis [ Time Frame: Day 0 to Month 44 ]
    Aetiology confirmed meningitis was assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.


Secondary Outcome Measures :
  1. Occurrence of probable meningitis (final classification) [ Time Frame: Day 0 to Month 44 ]
    Probable meningitis was assessed in children 5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.

  2. Occurrence of clinically suspected meningitis (final classification) [ Time Frame: Day 0 to Month 44 ]
  3. Occurrence of meningitis cases identified at site level (first line laboratory) [ Time Frame: Day 0 to Month 44 ]
    Site-level meningitis cases were assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.

  4. Occurrence of hospitalisation (including those attributed to an AESI, other AE, meningitis, or malaria) or death [ Time Frame: Day 0 to Month 44 ]
    Occurrence of hospitalisation was assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E:

  5. Occurrence of febrile convulsions following administration of routine EPI vaccine [ Time Frame: During the 7-day period (Days 0-6) and the 1-month period (Days 0-29) following vaccine administration ]
    Occurrence of febrile convulsions was assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.

  6. Occurrence of two events used as surveillance quality indicators: abscess at injection site [ Time Frame: During the 7-day period (Days 0-6) following vaccine administration for abscesses at injection site, and for foot positional deformation up to 44 months ]
    Occurrence of abscesses at injection site and foot positional deformation was assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.

  7. Occurrence of episodes of malaria using rapid diagnostic test (RDT) and/or microscopy [ Time Frame: Enrolled children will be followed up through home visits for a total period of 44 months ]
    Occurrence of episodes of malaria was assessed in children <5 years old, included in active surveillance, prior to implementation of RTS,S/AS01E.

  8. Occurrence of anaemia at hospital entry among hospitalised children [ Time Frame: From Day 0 to Month 44 ]
    Occurrence of anaemia was assessed in children <5 years old, included in active surveillance, prior to implementation of RTS,S/AS01E.

  9. Occurrence of hospitalisation [ Time Frame: From Day 0 to Month 44 ]
    Occurrence of hospitalisation was assessed in children <5 years old, included in active surveillance, prior to implementation of RTS,S/AS01E.

  10. Occurrence of death [ Time Frame: From Day 0 to Month 44 ]
    Occurrence of death was assessed in children <5 years old, included in active surveillance, prior to implementation of RTS,S/AS01E.



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent provided from either the parent(s) or LAR of the subject.
  • Subject living in the Health and Demographic Surveillance System (HDSS) area.
  • For enrolment in active surveillance: children must be <18 months of age. OR
  • For enrolment in enhanced hospitalisation surveillance: children must be <5 years of age and hospitalised at any time during the study.

Exclusion Criteria:

  • Child in care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374450


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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Burkina Faso
GSK Investigational Site Recruiting
Ouagadougou, Burkina Faso
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
PO BOX 02 Nouna, Burkina Faso
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Ghana
GSK Investigational Site Recruiting
Kintampo, Ghana
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Navrongo, Ghana
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Kenya
GSK Investigational Site Recruiting
Kisumu, Kenya
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
AMP (Agency Preventive Medicine)
CLS (Second line laboratory support)
Quintiles, Inc.
Mobile Phone Alert System Provider (Epi-concept)
RAFT (Francophone Africa Network for Telemedicine)
The PATH Malaria Vaccine Initiative (MVI)
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02374450     History of Changes
Other Study ID Numbers: 115055
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by GlaxoSmithKline:
Malaria
Surveillance study
Adverse Events of Specific Interest (AESI)
Children
Infants
Adverse events (AE) leading to hospitalisation or death
Meningitis
Epidemiology
Africa

Additional relevant MeSH terms:
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Malaria
Meningitis
Protozoan Infections
Parasitic Diseases
Central Nervous System Diseases
Nervous System Diseases