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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01190202
Date of registration:	26/08/2010
Prospective Registration:	Yes
Primary sponsor:	GlaxoSmithKline
Public title:	Epidemiology Study of Malaria Transmission Intensity in Africa
Scientific title:	Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Date of first enrolment:	March 14, 2011
Target sample size:	21618
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01190202
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other.
Phase:	N/A

Countries of recruitment
Burkina Faso	Gabon	Ghana	Kenya	Malawi	Tanzania

Contacts

Name:	GSK Clinical Trials
Address:
Telephone:
Email:
Affiliation:	GlaxoSmithKline

Key inclusion & exclusion 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.

Age minimum: 6 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria Vaccines

Malaria

Intervention(s)

Procedure: Blood sampling

Procedure: Assessment of body temperature

Primary Outcome(s)

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey [Time Frame: At each Survey visit]

Secondary Outcome(s)

Axillary Temperature at Visit in Survey 4 [Time Frame: At Survey visit]

Mean Number of Days With Fever at Survey 2 [Time Frame: During the survey period (approximatively 1 year)]

Mean Number of Days With Fever at Survey 4 [Time Frame: During the survey period (approximatively 1 year)]

Mean Number of Subjects Living in the Same House at Survey 3 [Time Frame: At Survey visit]

Mean Number of Subjects Living in the Same House at Survey 4 [Time Frame: At Survey visit]

Number of Subjects by Localisation and Type of Location at Survey 1 [Time Frame: At Survey visit]

Number of Subjects by Localisation and Type of Location at Survey 4 [Time Frame: At Survey visit]

Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3 [Time Frame: At Survey visit]

Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2 [Time Frame: At Survey visit]

Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4 [Time Frame: At Survey visit]

Axillary Temperature at Visit in Survey 2 [Time Frame: At Survey visit]

Mean Number of Days With Malaria Treatment at Survey 1 [Time Frame: During the 14 day-period before the malaria treatment]

Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density [Time Frame: During the survey period (approximatively 1 year)]

Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4 [Time Frame: At Survey visit]

Number of Subjects by Localisation and Type of Location at Survey 3 [Time Frame: At Survey visit]

Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density [Time Frame: During the survey period (approximatively 1 year)]

Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3 [Time Frame: At Survey visit]

Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density [Time Frame: During the survey period (approximatively 1 year)]

Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1 [Time Frame: In the last 24 hours or at the survey visit]

Mean Number of Days With Fever at Survey 3 [Time Frame: During the survey period (approximatively 1 year)]

Mean Number of Days With Malaria Treatment at Survey 4 [Time Frame: During the 14 day-period before the malaria treatment]

Axillary Temperature at Visit in Survey 3 [Time Frame: At Survey visit]

Number of Subjects With Anemia and Severe Anemia for Each Survey [Time Frame: During the survey period (approximatively 1 year)]

Mean Number of Subjects Living in the Same House at Survey 1 [Time Frame: At Survey visit]

Mean Number of Subjects Living in the Same House at Survey 2 [Time Frame: At Survey visit]

Number of Subjects Living in the Same House at Survey 3 [Time Frame: At Survey visit]

Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey [Time Frame: At each Survey visit]

Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1 [Time Frame: At Survey visit]

Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2 [Time Frame: At Survey visit]

Axillary Temperature at Visit in Survey 1 [Time Frame: At Survey visit]

Mean Number of Days With Fever at Survey 1 [Time Frame: During the survey period (approximatively 1 year)]

Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2 [Time Frame: At Survey visit]

Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4 [Time Frame: At Survey visit]

Mean Number of Days With Malaria Treatment at Survey 2 [Time Frame: During the 14 day-period before the malaria treatment]

Number of Subjects Living in the Same House at Survey 1 [Time Frame: At Survey visit]

Number of Subjects Living in the Same House at Survey 2 [Time Frame: At Survey visit]

Number of Subjects Living in the Same House at Survey 4 [Time Frame: At Survey visit]

Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4 [Time Frame: In the last 24 hours or at the survey visit]

Number of Subjects by Localisation and Type of Location at Survey 2 [Time Frame: At Survey visit]

Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1 [Time Frame: At Survey visit]

Mean Number of Days With Malaria Treatment at Survey 3 [Time Frame: During the 14 day-period before the malaria treatment]

Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey [Time Frame: At each Survey visit]

Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey [Time Frame: At each Survey visit]

Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4 [Time Frame: At Survey visit]

Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1 [Time Frame: At Survey visit]

Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2 [Time Frame: At Survey visit]

Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3 [Time Frame: At Survey visit]

Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1 [Time Frame: At Survey visit]

Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density [Time Frame: During the survey period (approximatively 1 year)]

Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2 [Time Frame: In the last 24 hours or at the survey visit]

Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3 [Time Frame: In the last 24 hours or at the survey visit]

Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3 [Time Frame: At Survey visit]

Secondary ID(s)

114001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The PATH Malaria Vaccine Initiative (MVI)

Ethics review

Results

Results available:	Yes
Date Posted:	18/08/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01190202

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