Clinical trial NCT01190202: Epidemiology Study of Malaria Transmission Intensity in Africa
Official title: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Malaria Vaccines
Keywords: Malaria
Plasmodium falciparum
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: The PATH Malaria Vaccine Initiative (MVI)
First posted: 2010-08-27
Enrollment: 21618
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).

Detailed description: This study is a multicenter epidemiology study at centers that are participating in GSK's pivotal Phase III candidate malaria vaccine 110021 ( NCT00866619) trial and will involve 4 annual cross sectional surveys performed preferably at peak transmission.

There will be no study vaccine administered in this epidemiology study.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* A male or female 6 months or older at the time of survey.
* Written informed consent obtained from the subject/from the parent(s)/ Legally Acceptable Representative(s) of the subject.

Exclusion Criteria:

* Child in care.
* Previous or current participation in any malaria vaccine trial.

Primary outcomes:
measure: Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey
timeFrame: At each Survey visit
Secondary outcomes:
measure: Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey
timeFrame: At each Survey visit
measure: Number of Subjects With Anemia and Severe Anemia for Each Survey
timeFrame: During the survey period (approximatively 1 year)
measure: Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density
timeFrame: During the survey period (approximatively 1 year)
measure: Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density
timeFrame: During the survey period (approximatively 1 year)
measure: Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density
timeFrame: During the survey period (approximatively 1 year)
measure: Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density
timeFrame: During the survey period (approximatively 1 year)
measure: Mean Number of Days With Malaria Treatment at Survey 1
timeFrame: During the 14 day-period before the malaria treatment
measure: Mean Number of Days With Malaria Treatment at Survey 2
timeFrame: During the 14 day-period before the malaria treatment
measure: Mean Number of Days With Malaria Treatment at Survey 3
timeFrame: During the 14 day-period before the malaria treatment
measure: Mean Number of Days With Malaria Treatment at Survey 4
timeFrame: During the 14 day-period before the malaria treatment
measure: Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1
timeFrame: In the last 24 hours or at the survey visit
measure: Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2
timeFrame: In the last 24 hours or at the survey visit
measure: Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3
timeFrame: In the last 24 hours or at the survey visit
measure: Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4
timeFrame: In the last 24 hours or at the survey visit
measure: Mean Number of Days With Fever at Survey 1
timeFrame: During the survey period (approximatively 1 year)
measure: Mean Number of Days With Fever at Survey 2
timeFrame: During the survey period (approximatively 1 year)
measure: Mean Number of Days With Fever at Survey 3
timeFrame: During the survey period (approximatively 1 year)
measure: Mean Number of Days With Fever at Survey 4
timeFrame: During the survey period (approximatively 1 year)
measure: Axillary Temperature at Visit in Survey 1
timeFrame: At Survey visit
measure: Axillary Temperature at Visit in Survey 2
timeFrame: At Survey visit
measure: Axillary Temperature at Visit in Survey 3
timeFrame: At Survey visit
measure: Axillary Temperature at Visit in Survey 4
timeFrame: At Survey visit
measure: Number of Subjects Living in the Same House at Survey 1
timeFrame: At Survey visit
measure: Number of Subjects Living in the Same House at Survey 2
timeFrame: At Survey visit
measure: Number of Subjects Living in the Same House at Survey 3
timeFrame: At Survey visit
measure: Number of Subjects Living in the Same House at Survey 4
timeFrame: At Survey visit
measure: Mean Number of Subjects Living in the Same House at Survey 1
timeFrame: At Survey visit
measure: Mean Number of Subjects Living in the Same House at Survey 2
timeFrame: At Survey visit
measure: Mean Number of Subjects Living in the Same House at Survey 3
timeFrame: At Survey visit
measure: Mean Number of Subjects Living in the Same House at Survey 4
timeFrame: At Survey visit
measure: Number of Subjects by Localisation and Type of Location at Survey 1
timeFrame: At Survey visit
measure: Number of Subjects by Localisation and Type of Location at Survey 2
timeFrame: At Survey visit
measure: Number of Subjects by Localisation and Type of Location at Survey 3
timeFrame: At Survey visit
measure: Number of Subjects by Localisation and Type of Location at Survey 4
timeFrame: At Survey visit
measure: Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1
timeFrame: At Survey visit
measure: Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2
timeFrame: At Survey visit
measure: Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3
timeFrame: At Survey visit
measure: Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3
timeFrame: At Survey visit
measure: Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4
timeFrame: At Survey visit
measure: Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey
timeFrame: At each Survey visit
measure: Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1
timeFrame: At Survey visit
measure: Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2
timeFrame: At Survey visit
measure: Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3
timeFrame: At Survey visit
measure: Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4
timeFrame: At Survey visit
measure: Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey
timeFrame: At each Survey visit
Other outcomes:
Locations:
city: Ouagadougou 01
country: Burkina Faso
facility: GSK Investigational Site
city: Lambaréné
country: Gabon
facility: GSK Investigational Site
city: Kintampo
country: Ghana
facility: GSK Investigational Site
city: Kumasi
country: Ghana
facility: GSK Investigational Site
city: Kisumu
country: Kenya
facility: GSK Investigational Site
city: Lilongwe
country: Malawi
facility: GSK Investigational Site
city: Dar-es-Salaam
country: Tanzania
facility: GSK Investigational Site
city: Korogwe, Tanga
country: Tanzania
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Drakeley C, Abdulla S, Agnandji ST, Fernandes JF, Kremsner P, Lell B, Mewono L, Bache BE, Mihayo MG, Juma O, Tanner M, Tahita MC, Tinto H, Diallo S, Lompo P, D'Alessandro U, Ogutu B, Otieno L, Otieno S, Otieno W, Oyieko J, Asante KP, Dery DB, Adjei G, Adeniji E, Atibilla D, Owusu-Agyei S, Greenwood B, Gesase S, Lusingu J, Mahende C, Mongi R, Segeja M, Adjei S, Agbenyega T, Agyekum A, Ansong D, Bawa JT, Boateng HO, Dandalo L, Escamilla V, Hoffman I, Maenje P, Martinson F, Carter T, Leboulleux D, Kaslow DC, Usuf E, Pircon JY, Bahmanyar ER. Longitudinal estimation of Plasmodium falciparum prevalence in relation to malaria prevention measures in six sub-Saharan African countries. Malar J. 2017 Oct 27;16(1):433. doi: 10.1186/s12936-017-2078-3.