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Trial record 99 of 110 for:    test | ( Map: Malawi )

Malaria Vaccine Evaluation Programme (MVPE)

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ClinicalTrials.gov Identifier: NCT03806465
Recruitment Status : Enrolling by invitation
First Posted : January 16, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
Global Fund
Gavi, The Vaccine Alliance
UNITAID
PATH
Information provided by (Responsible Party):
Patricia Njuguna, World Health Organization

Brief Summary:

This is an evaluation of feasibility, safety and impact of the RTS,S/AS01 vaccine introduction, implemented in a pilot programme by Ministries of Health using an expanded schedule of their routine EPI contacts in moderate to high malaria transmission settings in Ghana, Kenya and Malawi. The Ministries of Health in Ghana, Kenya and Malawi plan to introduce the malaria vaccine, sub nationally.

This provides an opportunity in each country to evaluate the following :

  1. To evaluate the programmatic feasibility to deliver a 4 dose schedule;
  2. To collect information on a larger scale on the safety of the malaria vaccine with focus on cerebral malaria and meningitis;
  3. To evaluate the impact of the malaria vaccine on all cause mortality.

Condition or disease Intervention/treatment
Malaria,Falciparum Feasibility Safety Mortality Biological: RTS,S/AS01E

Detailed Description:

An evaluation of the pilot implementation of RTS,S/AS01 through routine health systems in moderate to high malaria transmission settings in Ghana, Kenya and Malawi.

in the context of the new vaccine introduction, the Ministries of Health in the three countries will introduce the malaria vaccine (RTS,S/AS01) in a phased fashion (with some areas introducing the malaria vaccine first and the latter half, after the evaluation period) building on the national immunization programmes which routinely deliver vaccines and expanding the schedule of their routine EPI contacts.

The evaluation of the pilot implementation will run for a total of about 46 months in each country. This will focus on the three main primary objectives of feasibility, safety and impact. The data for this will be collected in the following ways.

Three household surveys will be conducted to evaluate the programmatic feasibility to deliver a 4 dose schedule at baseline (before vaccination starts), 18 months and 30 months after start of vaccination. Four to eight sentinel hospitals will be identified in each country to collect information on a larger scale on the safety of the malaria vaccine in children aged less than 5 years admitted with a focus on cases of cerebral malaria and meningitis. Community based mortality surveillance will be established in the areas to facilitate the evaluation of the impact of the malaria vaccine on all cause mortality.


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Study Type : Observational
Estimated Enrollment : 15800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Evaluation of the Cluster-randomised Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
Implementation cluster
These will be children living in the cluster aged 5 or 6 months for the first immunization presenting to the routine immunization clinic. They will receive the malaria vaccine, RTS,S/AS01E (Mosquirix) 0.5mls in the schedule as has been adapted by the country in addition to the routine vaccines as provided by the routine immunization clinic following the national schedule.
Biological: RTS,S/AS01E
The malaria vaccine, RTS,S/AS01E (Mosquirix) will be provided in a 0,1,2 and 18-21 month schedule as has been adapted by the evaluating countries.
Other Name: Mosquirix

Comparision cluster
These will be children living in the cluster will receive only the routine vaccines as provided by the routine immunization clinic following the national schedule. Routine vaccines include polio, rotavirus, pneumococcal conjugate, pentavalent, measles and yellow fever vaccines.



Primary Outcome Measures :
  1. The number of deaths of any cause [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of deaths of any cause in children aged 5-39 months.

  2. Number of children admitted with a diagnosis of probable and confirmed meningitis cases [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of children with probable and confirmed meningitis A probable case if in a suspected case, the macroscopic aspect of the CSF is turbid, cloudy or purulent; or the CSF leukocyte count is >10 cells/mm3. A confirmed case is if a suspected or probable case is laboratory confirmed by culturing or identifying (i.e. by polymerase chain reaction, immunochromatographic dipstick or latex agglutination) bacterial, viral or other aetiology in the CSF.

  3. Number of children admitted with a diagnosis of cerebral malaria [ Time Frame: From 0 to 30 months after vaccination starts ]
    Cerebral malaria is defined as Severe P. falciparum malaria with coma (Glasgow coma score < 11 in children two years of age or older [≥ 2 years] or Blantyre coma score < 3 in children less than two years of age [(< 2 years]); and If malaria with seizure: coma persisting for > 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis)

  4. Number of children aged 12-23 months who have completed the primary series (the 3 dose regime) of the malaria vaccine [ Time Frame: At 18 months after vaccination starts ]
    Prevalence of children aged 12-23 months who had completed three doses of RTS,S/AS01 at the second household survey

  5. Number of children aged 27-38 months who have completed the 4th dose of the malaria vaccine [ Time Frame: At 30 months after vaccination starts ]
    Prevalence of children aged 27-38 months who had completed four doses of RTS,S/AS01 at the third household survey


Secondary Outcome Measures :
  1. Number of deaths in hospitalised children by gender [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of deaths in hospitalized children stratified by gender in children aged 5-39 months.

  2. Number of malaria associated deaths in hospitalised children by gender [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of malaria specific deaths stratified by gender in hospitalized children aged 5-39 months.

  3. Number of children with a diagnosis of severe malaria [ Time Frame: From 0 to 30 months after vaccination starts ]
    Hospital admissions with malaria which meet WHO criteria for a diagnosis of severe malaria.

  4. Number of deaths excluding those attributed to trauma, poisoning and drowning [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of non traumatic deaths in children aged 5-39 months.

  5. Number of children with a diagnosis of aetiology confirmed meningitis [ Time Frame: 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of aetiologically confirmed meningitis admitted to sentinel hospitals

  6. Number of children with a diagnosis of suspected meningitis [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of suspected meningitis admitted to sentinel hospitals

  7. Number of children with a diagnosis of probable meningitis [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of probable meningitis admitted to sentinel hospitals

  8. Number of children with a diagnosis of malaria [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of malaria admitted to sentinel hospitals

  9. Number of children with a non-malaria diagnosis [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which do not meet WHO criteria for a diagnosis of malaria admitted to sentinel hospitals

  10. Number of children with a diagnosis of anaemia [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of anaemia admitted to sentinel hospitals . Anaemia is haemoglobin less than 11g/dL.

  11. Number of children who have received all their routine EPI vaccines as recommended by their national immunization schedule [ Time Frame: At 18 and 30 months after vaccination starts ]
    Routine EPI vaccines include all doses of OPV, pentavalent, rotavirus, pneumococcal and measles vaccines

  12. Number of children who have received all the recommended malaria prevention and control measures [ Time Frame: At 18 and 30 months after vaccination starts ]
    Recommended malaria prevention and control measures include insecticide treated bed nets, IPTi and indoor residual spraying.

  13. Number of children who have received all of the other key childhood interventions [ Time Frame: At 18 and 30 months after vaccination starts ]
    Other key childhood interventions include anti-helminth administration (deworming) and Vitamin A supplementation


Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will comprise children aged 5-48 months living in the areas geographically-defined for this evaluation of the RTS,S/AS01 Malaria Vaccine Implementation in three countries (Ghana, Kenya and Malawi) in sub-Saharan Africa.
Criteria

Inclusion Criteria:

  • Children aged 5-48 months

Exclusion Criteria:

  • Children aged less than 5 months or greater than 48 months

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): NCT03806465


Locations
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Ghana
Kintampo Health Research Centre
Kintampo, Ghana
Kenya
CDC Kenya Malaria Programme
Kisumu, Kenya
Malawi
College of Medicine
Blantyre, Malawi
Sponsors and Collaborators
World Health Organization
Global Fund
Gavi, The Vaccine Alliance
UNITAID
PATH
Investigators
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Principal Investigator: Don Mathanga, PhD College of Medicine, Malawi
Principal Investigator: Kwaku Poku Asante, PhD Kintampo Health Research Centre, Ghana
Principal Investigator: Aaron Samuels, MD CDC-Kenya Malaria Program

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Responsible Party: Patricia Njuguna, Medical Officer, World Health Organization
ClinicalTrials.gov Identifier: NCT03806465     History of Changes
Other Study ID Numbers: RTSS MVIP
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patricia Njuguna, World Health Organization:
Vaccine
Malaria
Africa
Child

Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs