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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 Vaccine

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ClinicalTrials.gov Identifier: NCT02374450
Recruitment Status : Active, not recruiting
First Posted : February 27, 2015
Last Update Posted : May 19, 2022
Sponsor:
Collaborators:
PATH
AMP (Agence de Médecine Préventive) (in French)
RAFT (Réseau en Afrique Francophone pour la Télémédecine) (in French)
Iqvia Pty Ltd
Parexel (Mobile Phone Alert System Provider)
CLS (Clinical Laboratory Services)
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date January 12, 2015
First Posted Date February 27, 2015
Last Update Posted Date May 19, 2022
Actual Study Start Date October 5, 2015
Estimated Primary Completion Date August 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2020)
  • Incidence of AESI [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    AESI include: Acute Disseminated Encephalomyelitis (ADEM), encephalitis,Guillain Barré Syndrome,hypotonic-hyporesponsive episode,generalised convulsive seizure,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. Incidence rates are calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time.The minimum at-risk period for the analyses is 2 weeks (W).All AESI expected to occur between 0-13 days (D) following dose administration is analysed with an at-risk period of 2 W. The 6W-at-risk period for AESI expected to occur between 14 D-6 W. The 3M and 6M-at-risk periods are for the AESI expected to occur between 6 W-3 M and 3-6 M, respectively. The at-risk period follows any dose, with a censoring of subjects when they receive the following dose.
  • Incidence of adverse events (AEs) leading to hospitalisation or death [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    AEs assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E. Incidence rates will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. The at-risk periods of 7 days and 30 days will follow any dose, with a censoring of subjects when they receive the following dose.
  • Incidence of aetiology confirmed meningitis [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Aetiology-confirmed meningitis assessment in children <5 years old, living in the study area, prior to implementation of RTS,S/AS01E. Aetiology-confirmed meningitis is defined by the presence of symptoms and/or signs of meningitis and the identification of any known aetiologic agent (bacterial or not) in the CSF. Incidence rates will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. An at-risk period of 12 months after any dose will be used.
Original Primary Outcome Measures
 (submitted: February 23, 2015)
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of protocol-defined potential AESI [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of serious adverse events leading to hospitalisation and death [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of confirmed meningitis (any aetiology) [ Time Frame: Day 0 to Month 24 ]
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2020)
  • Incidence of aetiology-confirmed and/or probable meningitis [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Aetiology-confirmed and/or probable meningitis assessment in children <5 years old, living in the study area, prior to implementation of RTS,S/AS01E. Aetiology-confirmed meningitis case is defined by the presence of symptoms and/or signs of meningitis and the identification of any known aetiologic agent (bacterial or not) in the CSF. Probable meningitis case is defined by the presence of symptoms and/or signs of meningitis and no aetiologic agent identified in the CSF, but with some abnormalities detected in the CSF (e.g. turbid macroscopic aspect, positive Gram, positive antigen test, pleiocytosis, abnormal glucose or protein levels), or positive blood culture to a bacterial agent. Incidence rates will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. An at-risk period of 12 months after any dose will be used.
  • Incidence of probable meningitis [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Probable meningitis assessed in children < 5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E. Incidence rates will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. An at-risk period of 12 months after any dose will be used.
  • Incidence of aetiology-confirmed, probable and/or clinically suspected meningitis [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Aetiology-confirmed, probable and/or clinically suspected meningitis assessment in children <5 years old, living in the study area, prior to implementation of RTS,S/AS01E. Clinically suspected meningitis case is defined by the presence of symptoms and/or signs of meningitis and if a CSF sample is available and all laboratory results are normal after second line laboratory testing, or if no CSF sample is available and no alternative diagnosis. Incidence rates will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. An at-risk period of 12 months after any dose will be used.
  • Occurrence of meningitis cases identified at site level (first line laboratory) [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Number of cases of meningitis based on lab testing performed at site level. Meningitis cases identified at site level (first line laboratory assessment) in children <5 years old, living in the study area, prior to implementation of RTS,S/AS01E.
  • Occurrence of risk factors for AESI, other AE leading to hospitalisation or death, meningitis and malaria [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Number of children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E with at least one risk.
  • Occurrences of causes of hospitalisation (including those attributed to an AESI, other AE, meningitis, or malaria) [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Occurrence of hospitalisation assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.
  • Number of deaths by cause (overall and by gender) [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    The number of deaths by cause is assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E.The analysis of death causes is classified by MedDRA and assessed overall and by gender.
  • Incidence of febrile convulsions following administration of routine EPI vaccines [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Febrile convulsions are assessed in children <5 years old, included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E. Febrile convulsions are defined as generalised seizures with measured fever greater than or equal to (≥) 37.5 degrees Celsius (°C) (axillary) or reported history of fever. Incidence rates will be calculated by dividing the number of subjects reporting at least one event over the follow-up period by the total person-time. Two at-risk periods will use: the 7-day period (Days 0-6) and the 1-month period (Days 0-29) following any vaccine administration.
  • Incidence of any malaria reported using rapid diagnostic test (RDT) and/or microscopy [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    The incidence of any malaria detected by RDT and/or microscopy is calculated by dividing the number of subjects reporting events over the follow-up period by the total person-time for children enrolled in active surveillance. Any malaria includes uncomplicated and severe cases, including cerebral malaria. Uncomplicated is defined as: Plasmodium parasitaemia greater than (>) 0 detected by microscopy and/or RDT, fever (temperature ≥ 37.5°C) and no signs of severity or evidence (clinical or laboratory) of vital organ dysfunction. Severe is defined as: P. falciparum parasitaemia > 0 detected by microscopy and/or RDT and one or more of the following: impaired consciousness, prostration, multiple convulsions, acidosis, hypoglycaemia, severe malarial anaemia, renal impairment, jaundice, pulmonary oedema, significant bleeding, shock, hyperparasitaemia. Cerebral malaria is defined as severe P. falciparum malaria with impaired consciousness.
  • Incidence of severe malaria reported using rapid diagnostic test (RDT) and/or microscopy [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    The incidence of severe malaria detected by RDT and/or microscopy is calculated by dividing the number of subjects reporting events over the follow-up period by the total person-time for children enrolled in the study.
  • Incidence of cerebral malaria reported using rapid diagnostic test (RDT) and/or microscopy [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    The incidence of cerebral malaria detected by RDT and/or microscopy will be calculated by dividing the number of subjects reporting events over the follow-up period by the total person-time for children enrolled in the study.
  • Prevalence of anaemia among hospitalised children [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    The prevalence for anaemia is computed by dividing the number of all cases by the number of enrolled children. All anaemia: haemoglobin <11 grams per deciliter (g/dL). Severe anaemia: haemoglobin <7g/dL.
  • Incidence of all-cause hospitalisations and hospitalisations attributed to malaria (including P. falciparum) [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    The hospitalisation cases are assessed in children <5 years old, included in active surveillance, prior to implementation of RTS,S/AS01E.The incidence of hospitalisation cases is calculated by dividing the number of children hospitalised during study period over the total person-time for children enrolled in active surveillance. Hospitalisation for malaria (including P. falciparum) is defined as: a hospitalised subject with malaria (including P. falciparum malaria) and for whom malaria is the primary cause of hospitalisation.
  • Mortality rate (all-cause mortality and deaths attributed to malaria [including P. falciparum]), overall and by gender [ Time Frame: During the entire study period (From Month 0 up to Month 60) ]
    Mortality rate is calculated by dividing the number of deaths due to any cause or due to malaria over the total person-time for children enrolled in the study.
Original Secondary Outcome Measures
 (submitted: February 23, 2015)
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of confirmed and suspected meningitis [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of febrile convulsions [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of anaemia among hospitalised children [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of clinical episodes of malaria [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of hospitalisations [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of deaths [ Time Frame: Day 0 to Month 24 ]
  • In children <3 years old, prior to implementation of RTS,S/AS01E: • Occurrence of two events used as surveillance quality indicators: abscess at injection site and foot positional deformation [ Time Frame: Day 0 to Month 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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 Vaccine
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
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 was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine is currently implemented, 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 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.

Detailed Description

The outcomes of interest (AESI, other AE leading to hospitalisation or death, and meningitis) as well as data on malaria morbidity and mortality will be captured through active and enhanced hospitalisation surveillance in children less than (<) 5 years of age. Children enrolled in active surveillance will be visited at their home at regular intervals during a period of 44 months. In addition to the home visits, all visits and hospitalisations to health care facilities will be recorded during this period. Thereafter there will be continuous monitoring of hospitalisations only; up to study end or up to the day the child reaches 5 years of age, whichever occurs first. For all children enrolled in enhanced hospitalisation surveillance, all hospitalisation events will be captured during the total study period. The protocol summary has been updated with protocol amendment 4 (dated 11-Dec-2015) information:

Rationale for amendment 3:

  • Participant recruitment has been modified: approximately 20,000 children will be enrolled in the active surveillance in the 6-12 weeks group (identified at first administration of DTP/HepB/Hib vaccine), to mimic administration of RTS,S/AS01E in the 6-12 weeks age group, and 20,000 children in the 5-17 months group (either selected children identified at first administration of DTP/HepB/Hib vaccine, or children aged 5 to <18 months and corresponding to a catch-up), to mimic administration of RTS,S/AS01E in the 5-17 months age group.
  • The term "passive surveillance" has been replaced by the term "enhanced hospitalisation surveillance".
  • The case definitions, ascertainment and laboratory investigation (including to determine aetiology) for meningitis cases have been clarified. The objectives and outcomes related to meningitis have been modified accordingly.
  • Case ascertainment for AESI has been clarified.
  • It was clarified that blood sampling is to be performed as per study procedures in case of AESI or meningitis. In case of neurological AESI or meningitis, if a cerebrospinal fluid (CSF) sample is taken as part of routine practice, part of the sample will be stored. Only serious adverse events related to blood sampling will be collected.
  • Limitations due to the sample size and the study design have been further discussed.
  • For clarity, consistency and comparability in the objectives, outcomes and methodologies, protocol amendment 3 text has been aligned in EPI-MALARIA-002 (115055) with the EPI-MALARIA-003 (115056) protocol.

Rationale for amendment 4:

  • The background section has been updated with data about cerebral malaria from a post-hoc analysis of the Phase III study MALARIA-055.
  • Additional secondary objectives have been added for estimation of probable meningitis and for estimation of the incidence of cerebral malaria using RDT and/or microscopy.
  • The design and the analysis have been modified to take into account implementation of a 4th dose of RTS,S/AS01E. In addition, the follow-up period after the last dose has been extended to correspond to the follow-up period of the children enrolled in EPI-MAL-003 (i.e. 24 months after the 4th dose of RTS,S/AS01E). Indeed, home visits at 12 months and 24 months after the last RTS,S/AS01E dose will help to capture protocol-defined diseases that may have long risk window periods and that may not have been identified if the subject did not visit a health care facility, and to monitor the occurrence of malaria episodes for evaluation of vaccine effect. The age of the study population has been adapted accordingly (< 5 years).
  • The section about sites participating to the study was updated following SAGE/MPAC recommendations of pilot implementations of RTS,S/AS01E in 3-5 distinct settings in SSA restricted to moderate-to-high transmission of malaria.
  • The activities related to home visits to detect malaria cases, including training of community health workers for systematic measurement of body temperature of all children, and availability of malaria tests have been clarified for alignment with the EPI-MAL-003 protocol.
  • It has been clarified that cases of malaria only detected during the annual visits planned for EPI-MAL-005 will not be included in the analysis of EPI-MAL-002. However, if the cases of malaria are detected during an EPI-MAL-005 home visit that coincides with a home visit scheduled in EPI-MAL-002, the events will be captured in EPI-MAL-002.
  • The case definitions for malaria have been revised, according to the 3rd edition of the WHO guidelines for the treatment of malaria (2015). In addition, a case definition for cerebral malaria has been added.
  • Case ascertainment by the external panel of experts has been clarified.
  • It has been clarified that severe/cerebral malaria cases and other AE leading to hospitalisation or death will be reviewed by the external panel of experts.
  • The incidence of other AE leading to hospitalisation or death, meningitis and malaria morbidity and mortality will be monitored in sub-populations of children with hemoglobinopathies and HIV-positive children.
  • The section about analysis of co-primary objectives has been revised to mention that additional at risk periods will be considered based on results as sensitivity analyses.
  • The section about analysis of secondary objectives has been revised for clarification of potential variables that may be considered for models, in line with information collected in eCRF, and for estimation of the incidence of cerebral malaria.
  • It has been clarified that an interim analysis will be performed with the data collected on all subjects after 6 months of follow-up following the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after V3 (5-17 months group).
  • The section about handling of missing data has been revised.
  • It has been clarified that data about seasonal malaria chemoprevention will be collected.

Other changes were made for simplification, clarification or consistency.

Rationale for amendment 5:

  • In order to have a synergy with the WHO pilot implementation, the study size was reduced from 40,000 to 30,000 children in active surveillance with at least 20,000 children enrolled where the RTS,S/AS01E vaccine will be implemented. Among the 30,000 children, approximately 15,000 children (with at least 10,000 children in sites where the vaccine will be implemented) will be enrolled in the 6-12 weeks group (to collect background data in this age group) and approximately 15,000 children (with at least 10,000 children in sites where the vaccine will be implemented) will be enrolled in the 5-17 months group (to mimic administration of RTS,S/AS01E in the 5-17 months age group). Study size updates involved multiple sections, e.g. Section 9.1 Study Design and Section 9.5 Study size.
  • For multiple sections: the number of countries and number of study sites has been updated following the WHO announcement that the RTS,S/AS01E vaccine will be first introduced in 3 countries (Ghana, Kenya and Malawi) through the MVIP.
  • For multiple sections: estimation of the mortality rate, overall and by gender, has been added.
  • For multiple sections: the informed consent process has been clarified "signed or witnessed and thumbprinted ICF".
  • For multiple sections: "or equivalent surveillance system" has been added after Health and Demographic Surveillance System (HDSS) and the term "study site(s)" or "study area" has been added.
  • For multiple sections: the replacement strategy has been updated.
  • For multiple sections: the duration of the recruitment period has been removed, as it could/cannot be respected in all sites due to logistical constraints.
  • For multiple sections: it was clarified that census rounds are scheduled at least once a year during the study periods instead of twice a year.
  • The milestones in Section 6 have been updated.
  • New sub-sections on "Severe malaria including cerebral malaria" and "Overall mortality by gender" have been added to Section 7.2 Safety results of the clinical development of RTS,S/AS01E.
  • The wording of "secondary objectives" on "describe the causes of hospitalisation" and "estimate the incidence of cerebral malaria" has been changed, and the secondary objective "To describe the causes of death, overall and by gender" has been added in Section 8.2 and in the corresponding part of Section 4 Abstract.
  • The opening paragraph of Section 8.2 Secondary Objectives and of the corresponding part of Section 4 Abstract has been updated.
  • The wording of the last two "study variables" / "study endpoints" on "Occurrence of hospitalisations" and "Occurrence of death" has been modified in Section 9.3.2 and in the corresponding part of Section 4 Abstract.
  • In Section 9.2.1 Study population: the text on "Estimated annual birth cohorts by study site" (Table 2) has been removed, with removal of planned number of sites in selected countries.
  • Section 9.2.5.3 Meningitis has been edited, including addition of a new opening paragraph, addition of "turbid macroscopic aspect" as a sign of CSF abnormality, and clarification that clinically suspected meningitis cases included subjects with no CSF sample available and no alternative diagnosis.
  • For consistency between the way the objectives and the endpoints are presented, and to avoid repeating several endpoints, the two sub-sections in Section 9.3.2 Secondary endpoints: "In children included in active or enhanced hospitalisation surveillance, prior to implementation of RTS,S/AS01E" and "In children included in active surveillance, prior to implementation of RTS,S/AS01E" have been replaced by one sub-section: "In children living in the study area, prior to implementation of RTS,S/AS01E", followed by all the secondary endpoints.
  • In Section 9.4.3 Study EPI-MAL-005 "changes in environmental factors such as rainfall" has been added to the parameters assessed in EPI-MAL-005.
  • Section 9.5 Study size has been updated as shown in bullet 1 above with greater detail on the estimates of observed incidence of events following dose administration based on either: 15,000 subjects, 10,000 subjects, the estimated birth cohort of 11,500 subjects and an estimated birth cohort of 17,250 children in Tables 6-9.
  • Section 9.7.6 Analysis of secondary safety objectives has been updated, including analysis of cerebral malaria of the causes of death, overall and by gender.

Finally, changes in study personnel have been included on the protocol cover page

Rationale for amendment 6

Protocol Amendment 6 has been put in place to document that the EPI-MAL-002 study sites in Burkina Faso will early terminate the study and that sites in Malawi, one of the countries where RTS,S/AS01E will be introduced through the MVIP will not take part in the study.

GSK, in agreement with WHO, decided to terminate the study EPI-MAL-002 in the two sites located in Burkina Faso, i.e. Nouna and Sapone. Briefly, it was previously decided that Burkina Faso sites would continue participating in EPI-MAL-002 until study end. However, given that the MVIP will not be conducted in this country, there is no scientific value to collect additional data (the EPI-MAL-002 data collected in Burkina Faso will neither be used for the before-after analyses, nor for the generation of EPI-MAL-002 indicators that inform any other analyses of the EPI-MAL-003 study). Therefore, the study EPI-MAL-002 in Burkina Faso sites has been early terminated and data collected and recorded to date in those sites will be reported in a descriptive way.

In order to align with the MVIP, the study sites for the GSK Phase IV studies have been selected from the 3 countries where the RTS,S/AS01E vaccine will be implemented (Ghana, Kenya and Malawi). Considering the RTS,S/AS01E vaccine implementation date in Malawi was planned in October 2018, the baseline data that might be collected in Malawi in the EPI-MAL-002 study would be too limited to be relevant for the before/after comparisons in this country. Therefore, GSK, in agreement with the WHO, decided to focus the conduct of the EPI-MAL-002 study in Ghana and Kenya, not initiating the study in Malawi, and partially compensating the expected sample size from Malawi sites by using the high recruitment observed from sites in Kenya (Kombewa) and Ghana (Kintampo) and extending recruitment in Ghana (Navrongo), hence limiting the impact on the before/after comparison study power.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Malaria
  • Malaria Vaccines
Intervention Procedure: Blood collection
For all hospitalised children suspected of having an AESI or meningitis, a sample of 5 ml of whole blood is collected and serum is stored.
Study Groups/Cohorts Active surveillance group and enhanced hospitalisation group
Children <18 months of age at time of enrolment 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).
Intervention: Procedure: Blood collection
Publications * RTS,S Epidemiology EPI-MAL-002 Study Group. Baseline incidence of meningitis, malaria, mortality and other health outcomes in infants and young sub-Saharan African children prior to the introduction of the RTS,S/AS01(E) malaria vaccine. Malar J. 2021 Apr 26;20(1):197. doi: 10.1186/s12936-021-03670-w. Erratum in: Malar J. 2021 Jun 7;20(1):252.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 18, 2022)
35334
Original Estimated Enrollment
 (submitted: February 23, 2015)
40000
Estimated Study Completion Date August 2, 2022
Estimated Primary Completion Date August 2, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Burkina Faso,   Ghana,   Kenya
Removed Location Countries  
 
Administrative Information
NCT Number NCT02374450
Other Study ID Numbers 115055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor GlaxoSmithKline
Original Study Sponsor Same as current
Collaborators
  • PATH
  • AMP (Agence de Médecine Préventive) (in French)
  • RAFT (Réseau en Afrique Francophone pour la Télémédecine) (in French)
  • Iqvia Pty Ltd
  • Parexel (Mobile Phone Alert System Provider)
  • CLS (Clinical Laboratory Services)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2022