Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Study Details
Study Description
Brief Summary
This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western Africa.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Two subsequent studies (EPI-MAL-002 and EPI-MAL-003) are planned to monitor vaccine safety prior to and after implementation of the RTS,S/AS01 candidate malaria vaccine. EPI-MAL-002 will take place before RTS,S is authorised and EPI-MAL-003 will start when RTS,S is registered and authorised in the country. A cross-sectional survey at peak transmission will provide by-site point estimates of Parasite prevalence (PP) and malaria control measure coverage in the areas participating in EPI-MAL-002/-003. EPI-MAL-006 will be conducted in advance of EPI-MAL-002/-003 in order to assess PP and malaria control measures to inform enrollment in these studies. The age group for enrollment (≥6 months - <10 years) will permit analysis of PP according to the World Health Organization (WHO) definition (2-9 years) and by the Joint Technical Expert Group (JTEG) suggested age (<5 years).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Overall Study Group Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
Procedure: Capillary blood sample
Capillary blood sample (up to 200µL) for determination of PP (blood slides).
Other: Data collection
Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center [At Epoch 1 (Survey visit) (approximately 35 days)]
PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia.
- Number of Subjects With Malaria Control Interventions (MCIs), Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
- Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status [At Epoch 1 (Survey visit) (approximately 35 days)]
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
- Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso [At Epoch 1 (Survey visit) (approximately 35 days)]
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
- Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso [At Epoch 1 (Survey visit) (approximately 35 days)]
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
- Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal [At Epoch 1 (Survey visit) (approximately 35 days)]
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D.
- Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal [At Epoch 1 (Survey visit) (approximately 35 days)]
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Secondary Outcome Measures
- Number of Subjects With Other Medical History Characteristics, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
The medical history characteristics were as follows: -subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated Bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS).
- Number of Subjects by Age, According to P. Falciparum Infection Status [At Epoch 1 (Survey visit) (approximately 35 days)]
The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status.
- Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status [At Epoch 1 (Survey visit) (approximately 35 days)]
The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status.
- Number of Subjects by Gender, According to P. Falciparum Infection Status [At Epoch 1 (Survey visit) (approximately 35 days)]
The gender characteristics were summarized by P. falciparum infection status.
- Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers [At Epoch 1 (Survey visit) (approximately 35 days)]
Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject's blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation.
- Number of Subjects With Anti-malarial Therapy, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months.
- Number of Days With Therapy, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
- Days of Malaria Treatment, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
This endpoint presents results per total centers and across all age categories.
- Number of Subjects With Fever, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was ≥ 37.5 ◦C.
- Days With Fever, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
This endpoint presents results per total centers and across all age categories.
- Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house.
- Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH).
- Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
- Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
- Number of Subjects With P. Falciparum by Situation Area, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants.
- Number of Subjects With Different P. Falciparum Densities by Situation Area and Center [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
- Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water).
- Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center [At Epoch 1 (Survey visit) (approximately 35 days)]
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
-
Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.
Exclusion Criteria:
-
Child in care.
-
Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Nouna | Burkina Faso | ||
| 2 | GSK Investigational Site | Ouagadougou | Burkina Faso | ||
| 3 | GSK Investigational Site | Dakar | Senegal |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 200187
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Period Title: Overall Study | |
| STARTED | 2421 |
| COMPLETED | 2421 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Overall Participants | 2421 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
4.0
(2.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1155
47.7%
|
| Male |
1266
52.3%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center |
|---|---|
| Description | PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol (ATP) cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | 0.5-4Y Group | 5-9Y Group |
|---|---|---|
| Arm/Group Description | Subjects aged 6 months to 4 years (Y) old, who were infected or not infected with P. falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. | Subjects aged 5 to 9 years (Y) old, who were infected or not infected with P. falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 1614 | 807 |
| NOU-BF |
235
9.7%
|
153
NaN
|
| OUA-BF |
167
6.9%
|
141
NaN
|
| DA-1-SE |
2
0.1%
|
1
NaN
|
| DA-2-SE |
5
0.2%
|
3
NaN
|
| Total |
409
16.9%
|
298
NaN
|
| Title | Number of Subjects With Malaria Control Interventions (MCIs), Overall |
|---|---|
| Description | MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM) |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| UMc > 7D, Yes |
122
5%
|
| UMc > 7D, Missing/No |
2299
95%
|
| UIs > 7D, Yes |
65
2.7%
|
| UIs > 7D, Missing/No |
2356
97.3%
|
| UCR > 7D, Yes |
12
0.5%
|
| UCR > 7D, Missing/No |
2409
99.5%
|
| UTR > 7D, Yes |
278
11.5%
|
| UTR > 7D, Missing/No |
2143
88.5%
|
| Una >7D, Yes |
1979
81.7%
|
| Una >7D, Missing/No |
442
18.3%
|
| Uirs past 12M, Yes |
89
3.7%
|
| Uirs past 12M, Missing/No |
2332
96.3%
|
| Uirs-nM [1] |
0
0%
|
| Uirs-nM [2] |
60
2.5%
|
| Uirs-nM [3] |
8
0.3%
|
| Uirs-nM [4] |
1
0%
|
| Uirs-nM [5] |
0
0%
|
| Uirs-nM [6] |
1
0%
|
| Uirs-nM [7] |
0
0%
|
| Uirs-nM [8] |
0
0%
|
| Uirs-nM [9] |
18
0.7%
|
| Uirs-nM [10] |
1
0%
|
| Uirs-nM, Missing |
2332
96.3%
|
| Title | Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status |
|---|---|
| Description | MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM) |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group | NOT-INF Group |
|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. | Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite (NOT-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 707 | 1714 |
| Use of Mosquito coils over 7 days |
39
1.6%
|
83
NaN
|
| Use of insecticide sprays over 7 days |
15
0.6%
|
50
NaN
|
| Use of commercial repellents over 7 days |
4
0.2%
|
8
NaN
|
| Use of traditional repellents over 7 days |
3
0.1%
|
275
NaN
|
| Use of none of the above over 7 days |
649
26.8%
|
1330
NaN
|
| Use of indoor residual spray in past 12 months |
3
0.1%
|
86
NaN
|
| Use of indoor residual spray in past 1 month |
0
0%
|
0
NaN
|
| Use of indoor residual spray in past 2 months |
1
0%
|
59
NaN
|
| Use of indoor residual spray in past 3 months |
1
0%
|
7
NaN
|
| Use of indoor residual spray in past 4 months |
0
0%
|
1
NaN
|
| Use of indoor residual spray in past 5 months |
0
0%
|
0
NaN
|
| Use of indoor residual spray in past 6 months |
1
0%
|
0
NaN
|
| Use of indoor residual spray in past 7 months |
0
0%
|
0
NaN
|
| Use of indoor residual spray in past 8 months |
0
0%
|
0
NaN
|
| Use of indoor residual spray in past 9 months |
0
0%
|
18
NaN
|
| Use of indoor residual spray in past 10 months |
0
0%
|
1
NaN
|
| Title | Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso |
|---|---|
| Description | MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 388 |
| MT PAST 14D, YES VS. NO |
0.323
|
| NDMT, ≥4 DAYS VS. ONGOING |
0.917
|
| NDMT, 1-3 DAYS VS. ONGOING |
0.596
|
| OM PAST 14D, YES VS. NO |
0.563
|
| NDOM, 1-7 DAYS VS. ONGOING |
1.155
|
| NDOM, ≥8 DAYS VS. ONGOING |
NA
|
| WSH3MM, YES VS. NO |
0.612
|
| SSUMNNBV, YES VS. NO |
0.447
|
| NN < 1Y, YES VS. NO |
1.952
|
| IB, YES VS. NO |
0.677
|
| P/TB, YES VS. NO |
1.360
|
| HS, ≥5 VS. <5 |
0.311
|
| UMC > 7D, YES VS. MISSING/NO |
1.158
|
| UIS > 7D, YES VS. MISSING/NO |
0.456
|
| UCR > 7D, YES VS. MISSING/NO |
0.857
|
| UNA >7D, YES VS. MISSING/NO |
1.339
|
| UIRS PAST 12M, YES VS. NO |
NA
|
| Title | Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso |
|---|---|
| Description | MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 308 |
| MT PAST 14D, YES VS. NO |
0.143
|
| NDMT, ≥4 DAYS VS. ONGOING |
NA
|
| NDMT, 1-3 DAYS VS. ONGOING |
0.341
|
| OM PAST 14D, YES VS. NO |
0.300
|
| NDOM, 1-7 DAYS VS. ONGOING |
0.568
|
| NDOM, ≥8 DAYS VS. ONGOING |
NA
|
| WSH3MM, YES VS. NO |
1.146
|
| SSUMNNBV, YES VS. NO |
0.956
|
| NN < 1Y, YES VS. NO |
1.163
|
| IB, YES VS. NO |
0.699
|
| P/TB, YES VS. NO |
0.376
|
| HS, ≥5 VS. <5 |
NA
|
| UMC > 7D, YES VS. MISSING/NO |
3.829
|
| UIS > 7D, YES VS. MISSING/NO |
NA
|
| UCR > 7D, YES VS. MISSING/NO |
NA
|
| UTR > 7D, NOT PERFORMED |
NA
|
| UNA >7D, YES VS. MISSING/NO |
0.208
|
| UIRS PAST 12M, YES VS. NO |
0.948
|
| Title | Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal |
|---|---|
| Description | MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 3 |
| MT PAST 14D, YES VS. NO |
NA
|
| OM PAST 14D, YES VS. NO |
7.395
|
| NDOM, ≥ 8 days vs. Ongoing |
NA
|
| NDOM, 1-7 days vs. Ongoing |
NA
|
| WSH3MM, YES VS. NO |
NA
|
| SSUMNNBV, YES VS. NO |
0.948
|
| NN < 1Y, YES VS. NO |
NA
|
| IB, YES VS. NO |
NA
|
| P/TB, YES VS. NO |
NA
|
| UMC > 7D, YES VS. MISSING/NO |
5.383
|
| UIS > 7D, YES VS. MISSING/NO |
NA
|
| UTR > 7D, YES VS. MISSING/NO |
NA
|
| UNA >7D, YES VS. MISSING/NO |
0.484
|
| UIRS PAST 12M, YES VS. NO |
NA
|
| Title | Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal |
|---|---|
| Description | MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 8 |
| MT PAST 14D, YES VS. NO |
NA
|
| OM PAST 14D, YES VS. N |
2.652
|
| NDOM, 1-7 DAYS VS. ONGOING |
NA
|
| NDOM, ≥8 DAYS VS. ONGOING |
0.340
|
| WSH3MM, YES VS. NO |
NA
|
| SSUMNNBV, YES VS. NO |
NA
|
| NN < 1Y, YES VS. NO |
NA
|
| IB, YES VS. NO |
NA
|
| P/TB, YES VS. NO |
0.779
|
| UMC > 7D, YES VS. MISSING/NO |
NA
|
| UIS > 7D, YES VS. MISSING/NO |
NA
|
| UCR > 7D, YES VS. MISSING/NO |
NA
|
| UTR > 7D, Yes vs. Missing/NO |
1.007
|
| UNA >7D, YES VS. MISSING/NO |
1.036
|
| UIRS PAST 12M, YES VS. NO |
NA
|
| Title | Number of Subjects With Other Medical History Characteristics, Overall |
|---|---|
| Description | The medical history characteristics were as follows: -subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated Bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS). |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| SSUMNNBV, YES |
2023
83.6%
|
| SSUMNNBV, NO |
398
16.4%
|
| NN < 1Y, YES |
1591
65.7%
|
| NN < 1Y, NO |
431
17.8%
|
| NN < 1Y, MISSING/NA |
399
16.5%
|
| IB, YES |
1618
66.8%
|
| IB, NO |
405
16.7%
|
| IB, MISSING/NA |
398
16.4%
|
| P/TB, YES |
406
16.8%
|
| P/TB, NO |
1617
66.8%
|
| P/TB, MISSING/NA |
398
16.4%
|
| HS < 5 |
17
0.7%
|
| HS ≥ 5 |
389
16.1%
|
| HS, MISSING/NA |
2015
83.2%
|
| Title | Number of Subjects by Age, According to P. Falciparum Infection Status |
|---|---|
| Description | The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group | NOT-INF Group |
|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years (Y) old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. | Subjects aged between 6 months to 9 years (Y) old, who were not infected with P. falciparum parasite (NOT-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 707 | 1714 |
| 0 years olds |
48
2%
|
202
NaN
|
| 1 year olds |
98
4%
|
380
NaN
|
| 2 year olds |
131
5.4%
|
348
NaN
|
| 3 year olds |
71
2.9%
|
136
NaN
|
| 4 year olds |
61
2.5%
|
139
NaN
|
| 5 year olds |
55
2.3%
|
106
NaN
|
| 6 year olds |
53
2.2%
|
109
NaN
|
| 7 year olds |
59
2.4%
|
104
NaN
|
| 8 year olds |
66
2.7%
|
92
NaN
|
| 9 year olds |
65
2.7%
|
98
NaN
|
| Title | Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status |
|---|---|
| Description | The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group | NOT-INF Group |
|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years (Y) old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. | Subjects aged between 6 months to 9 years (Y) old, who were not infected with P. falciparum parasite (NOT-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 707 | 1714 |
| 0.5Y - 4Y |
409
16.9%
|
1205
NaN
|
| 5Y - 9Y |
298
12.3%
|
509
NaN
|
| Title | Number of Subjects by Gender, According to P. Falciparum Infection Status |
|---|---|
| Description | The gender characteristics were summarized by P. falciparum infection status. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | PF-INF Group | NOT-INF Group |
|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years (Y) old, who were infected with P. falciparum parasite (PF-INF). Infection status was assessed using a blood smear slide and determined using microscopy. | Subjects aged between 6 months to 9 years (Y) old, who were not infected with P. falciparum parasite (NOT-INF). Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 707 | 1714 |
| Female |
337
13.9%
|
818
NaN
|
| Male |
370
15.3%
|
896
NaN
|
| Title | Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers |
|---|---|
| Description | Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject's blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | 0.5-4Y GROUP | 5-9Y GROUP |
|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 4 years (Y) old, who were infected or not infected with Plasmodium parasites. Infection status was assessed using a blood smear slide and determined using microscopy. | Subjects aged between 5 to 9 years (Y) old, who were infected or not infected with Plasmodium parasites. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 1614 | 807 |
| P. Malariae, Positive |
23
1%
|
32
NaN
|
| P. Malariae, Negative |
1591
65.7%
|
775
NaN
|
| P. Vivax, Positive |
0
0%
|
0
NaN
|
| P. Vivax, Negative |
1614
66.7%
|
807
NaN
|
| P. Ovale, Positive |
4
0.2%
|
5
NaN
|
| P. Ovale, Negative |
1610
66.5%
|
802
NaN
|
| Title | Number of Subjects With Anti-malarial Therapy, Overall |
|---|---|
| Description | Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| MT IN PAST 14 DAYS, YES |
187
7.7%
|
| MT IN PAST 14 DAYS, NO |
2234
92.3%
|
| OM IN PAST 14 DAYS, YES |
419
17.3%
|
| OM IN PAST 14 DAYS, NO |
2002
82.7%
|
| MH IN THE LAST 3 MONTHS, YES |
60
2.5%
|
| MH IN THE LAST 3 MONTHS, NO |
2361
97.5%
|
| Title | Number of Days With Therapy, Overall |
|---|---|
| Description | The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| EDMT, Ongoing |
26
|
| EDMT, 1-3 days |
155
|
| EDMT, ≥ 4days |
3
|
| EDMT, Missing/NA |
2237
|
| DOM, Ongoing |
101
|
| DOM, 1-7 days |
310
|
| DOM, ≥ 8 days |
7
|
| DOM, Missing/NA |
2003
|
| Title | Days of Malaria Treatment, Overall |
|---|---|
| Description | This endpoint presents results per total centers and across all age categories. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| Mean (Standard Deviation) [Days] |
3.0
(0.81)
|
| Title | Number of Subjects With Fever, Overall |
|---|---|
| Description | Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was ≥ 37.5 ◦C. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| F 24h, Yes |
331
13.7%
|
| F 24h, No |
2090
86.3%
|
| F* at V, Yes |
179
7.4%
|
| F* at V, No |
2241
92.6%
|
| F* at V, Missing |
1
0%
|
| Title | Days With Fever, Overall |
|---|---|
| Description | This endpoint presents results per total centers and across all age categories. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| Mean (Standard Deviation) [Days] |
3.0
(2.69)
|
| Title | Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall |
|---|---|
| Description | The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| PLSPH-PES, <3/1 |
517
21.4%
|
| PLSPH-PES, 4-5/1 |
590
24.4%
|
| PLSPH-PES, >5/1 |
864
35.7%
|
| PLSPH-PES, <3/2 |
54
2.2%
|
| PLSPH-PES, 4-5/2 |
112
4.6%
|
| PLSPH-PES, >5/2 |
214
8.8%
|
| PLSPH-PES, <3/3 |
0
0%
|
| PLSPH-PES, 4-5/3 |
15
0.6%
|
| PLSPH-PES, >5/3 |
42
1.7%
|
| PLSPH-PES, 4-5/>3 |
0
0%
|
| PLSPH-PES, >5/>3 |
13
0.5%
|
| Title | Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall |
|---|---|
| Description | The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH). |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| Mean (Standard Deviation) [Persons Living in Same Part of House] |
7.8
(6.49)
|
| Title | Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center |
|---|---|
| Description | The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Low PD Group | Medium PD Group | High PD Group | Vhigh PD Group | Neg PD Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, with low P. falciparum parasite density (<2500 parasite per µL). | Subjects aged between 6 months to 9 years old, with medium P. falciparum parasite density (2500 - 9999 parasite per µL). | Subjects aged between 6 months to 9 years old, with high P. falciparum parasite density (10000 - 19999 parasite per µL). | Subjects aged between 6 months to 9 years old, with very high P. falciparum parasite density (≥20000 parasite per µL). | Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite. |
| Measure Participants | 411 | 164 | 70 | 62 | 1714 |
| NOU-BF, PLSP-PES, <3/1 |
85
3.5%
|
34
NaN
|
14
NaN
|
11
NaN
|
68
NaN
|
| NOU-BF, PLSP-PES, 4-5/1 |
86
3.6%
|
38
NaN
|
17
NaN
|
8
NaN
|
93
NaN
|
| NOU-BF, PLSP-PES, >5/1 |
49
2%
|
22
NaN
|
6
NaN
|
4
NaN
|
57
NaN
|
| NOU-BF, PLSP-PES, <3/2 |
1
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, PLSP-PES, 4-5/2 |
4
0.2%
|
2
NaN
|
2
NaN
|
0
NaN
|
4
NaN
|
| NOU-BF, PLSP-PES, >5/2 |
4
0.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, PLSP-PES, <3/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, PLSP-PES, 4-5/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, PLSP-PES, >5/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, PLSP-PES, 4-5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, PLSP-PES, >5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| OUA-BF, PLSP-PES, <3/1 |
67
2.8%
|
26
NaN
|
15
NaN
|
16
NaN
|
122
NaN
|
| OUA-BF, PLSP-PES, 4-5/1 |
44
1.8%
|
24
NaN
|
12
NaN
|
14
NaN
|
100
NaN
|
| OUA-BF, PLSP-PES, >5/1 |
7
0.3%
|
3
NaN
|
2
NaN
|
3
NaN
|
17
NaN
|
| OUA-BF, PLSP-PES, <3/2 |
16
0.7%
|
3
NaN
|
0
NaN
|
1
NaN
|
24
NaN
|
| OUA-BF, PLSP-PES, 4-5/2 |
28
1.2%
|
10
NaN
|
0
NaN
|
1
NaN
|
19
NaN
|
| OUA-BF, PLSP-PES, >5/2 |
5
0.2%
|
1
NaN
|
0
NaN
|
1
NaN
|
7
NaN
|
| OUA-BF, PLSP-PES, <3/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| OUA-BF, PLSP-PES, 4-5/3 |
7
0.3%
|
0
NaN
|
0
NaN
|
1
NaN
|
1
NaN
|
| OUA-BF, PLSP-PES, >5/3 |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
| OUA-BF, PLSP-PES, 4-5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| OUA-BF, PLSP-PES, >5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, PLSP-PES, <3/1 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
59
NaN
|
| DA-1-SE, PLSP-PES, 4-5/1 |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
139
NaN
|
| DA-1-SE, PLSP-PES, >5/1 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
235
NaN
|
| DA-1-SE, PLSP-PES, <3/2 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
8
NaN
|
| DA-1-SE, PLSP-PES, 4-5/2 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
42
NaN
|
| DA-1-SE, PLSP-PES, >5/2 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
92
NaN
|
| DA-1-SE, PLSP-PES, <3/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, PLSP-PES, 4-5/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
6
NaN
|
| DA-1-SE, PLSP-PES, >5/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
15
NaN
|
| DA-1-SE, PLSP-PES, 4-5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, PLSP-PES, >5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
4
NaN
|
| DA-2-SE, PLSP-PES, <3/1 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, PLSP-PES, 4-5/1 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
12
NaN
|
| DA-2-SE, PLSP-PES, >5/1 |
6
0.2%
|
0
NaN
|
1
NaN
|
0
NaN
|
452
NaN
|
| DA-2-SE, PLSP-PES, <3/2 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, PLSP-PES, 4-5/2 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, PLSP-PES, >5/2 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
104
NaN
|
| DA-2-SE, PLSP-PES, <3/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, PLSP-PES, 4-5/3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, PLSP-PES, >5/3 |
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
23
NaN
|
| DA-2-SE, PLSP-PES, 4-5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, PLSP-PES, >5/>3 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
9
NaN
|
| Title | Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center |
|---|---|
| Description | The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Low PD Group | Medium PD Group | High PD Group | Vhigh PD Group | Neg PD Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, with low P. falciparum parasite density (<2500 parasite per µL). | Subjects aged between 6 months to 9 years old, with medium P. falciparum parasite density (2500 - 9999 parasite per µL). | Subjects aged between 6 months to 9 years old, with high P. falciparum parasite density (10000 - 19999 parasite per µL). | Subjects aged between 6 months to 9 years old, with very high P. falciparum parasite density (≥20000 parasite per µL). | Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite. |
| Measure Participants | 411 | 164 | 70 | 62 | 1714 |
| NOU-BF, PLSPH |
4.5
(2.29)
|
4.6
(2.48)
|
4.2
(1.30)
|
4.2
(1.68)
|
4.7
(2.21)
|
| OUA-BF, PLSPH |
3.8
(1.21)
|
3.8
(1.20)
|
3.7
(1.14)
|
3.7
(1.45)
|
3.8
(1.23)
|
| DA-1-SE, PLSPH |
5.0
(0.00)
|
5.0
(0.00)
|
NA
(NA)
|
4.0
(0.00)
|
8.0
(4.94)
|
| DA-2-SE, PLSPH |
16.2
(5.91)
|
NA
(NA)
|
9.0
(0.00)
|
9.0
(0.00)
|
15.0
(7.73)
|
| Title | Number of Subjects With P. Falciparum by Situation Area, Overall |
|---|---|
| Description | The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| Situation area, Rural |
2127
87.9%
|
| Situation area, Urban |
294
12.1%
|
| Situation area, Semi-rural |
0
0%
|
| Type of Location, Large city |
14
0.6%
|
| Type of Location, Small city |
0
0%
|
| Type of Location, Town |
282
11.6%
|
| Type of Location, Countryside |
2125
87.8%
|
| Title | Number of Subjects With Different P. Falciparum Densities by Situation Area and Center |
|---|---|
| Description | The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Low PD Group | Medium PD Group | High PD Group | Vhigh PD Group | Neg PD Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, with low P. falciparum parasite density (<2500 parasite per µL). | Subjects aged between 6 months to 9 years old, with medium P. falciparum parasite density (2500 - 9999 parasite per µL). | Subjects aged between 6 months to 9 years old, with high P. falciparum parasite density (10000 - 19999 parasite per µL). | Subjects aged between 6 months to 9 years old, with very high P. falciparum parasite density (≥20000 parasite per µL). | Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite. |
| Measure Participants | 411 | 164 | 70 | 62 | 1714 |
| NOU-BF, Situation area, Rural |
129
5.3%
|
71
NaN
|
23
NaN
|
16
NaN
|
84
NaN
|
| NOU-BF, Situation area, Urban |
100
4.1%
|
25
NaN
|
17
NaN
|
7
NaN
|
138
NaN
|
| NOU-BF, Situation area, semi-rural |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, Type of Location, Large city |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, Type of Location, Small city |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| NOU-BF, Type of Location, Town |
97
4%
|
25
NaN
|
16
NaN
|
7
NaN
|
135
NaN
|
| NOU-BF, Type of Location, Countryside |
132
5.5%
|
70
NaN
|
24
NaN
|
16
NaN
|
87
NaN
|
| OUA-BF, Situation area, Rural |
174
7.2%
|
67
NaN
|
27
NaN
|
37
NaN
|
289
NaN
|
| OUA-BF, Situation area, Urban |
1
0%
|
0
NaN
|
2
NaN
|
0
NaN
|
3
NaN
|
| OUA-BF, Situation area, semi-rural |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| OUA-BF, Type of Location, Large city |
2
0.1%
|
0
NaN
|
1
NaN
|
0
NaN
|
5
NaN
|
| OUA-BF, Type of Location, Small city |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| OUA-BF, Type of Location, Town |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| OUA-BF, Type of Location, Countryside |
173
7.1%
|
67
NaN
|
28
NaN
|
37
NaN
|
287
NaN
|
| DA-1-SE, Situation area, Rural |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
600
NaN
|
| DA-1-SE, Situation area, Urban |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, Situation area, semi-rural |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, Type of Location, Large city |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
5
NaN
|
| DA-1-SE, Type of Location, Small city |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, Type of Location, Town |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-1-SE, Type of Location, Countryside |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
595
NaN
|
| DA-2-SE, Situation area, Rural |
6
0.2%
|
0
NaN
|
1
NaN
|
1
NaN
|
599
NaN
|
| DA-2-SE, Situation area, Urban |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| DA-2-SE, Situation area, semi-rural |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, Type of Location, Large city |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, Type of Location, Small city |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| DA-2-SE, Type of Location, Town |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
| DA-2-SE, Type of Location, Countryside |
6
0.2%
|
0
NaN
|
1
NaN
|
1
NaN
|
598
NaN
|
| Title | Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall |
|---|---|
| Description | The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water). |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Overall Study Group |
|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. |
| Measure Participants | 2421 |
| MHCM walls, mud |
1176
48.6%
|
| MHCM walls, brick |
728
30.1%
|
| MHCM walls, cement/plaster |
140
5.8%
|
| MHCM walls, cement/paint |
365
15.1%
|
| MHCM walls, other |
12
0.5%
|
| MHCM floor, natural floor* |
1283
53%
|
| MHCM floor, rudimentary floor* |
16
0.7%
|
| MHCM floor, vinyl oe asphalt strips |
95
3.9%
|
| MHCM floor, ceramic tiles |
43
1.8%
|
| MHCM floor, cement |
980
40.5%
|
| MHCM floor, carpet |
3
0.1%
|
| MHCM floor, other |
1
0%
|
| MHCM roof, glass/palm |
632
26.1%
|
| MHCM roof, iron sheet |
1493
61.7%
|
| MHCM roof, tiles |
290
12%
|
| MHCM roof, missing |
6
0.2%
|
| MHCM windows/eaves, closed |
968
40%
|
| MHCM windows/eaves, open |
653
27%
|
| MHCM windows/eaves, partially open |
405
16.7%
|
| MHCM windows/eaves, missing |
395
16.3%
|
| MHCM nets, not present |
2005
82.8%
|
| MHCM nets, present on all windows |
16
0.7%
|
| MHCM nets, present on some windows |
6
0.2%
|
| MHCM nets, missing |
394
16.3%
|
| MSDW, bottled water |
2
0.1%
|
| MSDW, closed water source % |
1706
70.5%
|
| MSDW, open water source % |
712
29.4%
|
| MSDW, not applicable |
1
0%
|
| PE, Yes |
361
14.9%
|
| PE, No |
2060
85.1%
|
| Title | Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center |
|---|---|
| Description | The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers. |
| Time Frame | At Epoch 1 (Survey visit) (approximately 35 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available. |
| Arm/Group Title | Low PD Group | Medium PD Group | High PD Group | Vhigh PD Group | Neg PD Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects aged between 6 months to 9 years old, with low P. falciparum parasite density (<2500 parasite per µL). | Subjects aged between 6 months to 9 years old, with medium P. falciparum parasite density (2500 - 9999 parasite per µL). | Subjects aged between 6 months to 9 years old, with high P. falciparum parasite density (10000 - 19999 parasite per µL). | Subjects aged between 6 months to 9 years old, with very high P. falciparum parasite density (≥20000 parasite per µL). | Subjects aged between 6 months to 9 years old, who were not infected with P. falciparum parasite. |
| Measure Participants | 411 | 164 | 70 | 62 | 1714 |
| MHCM walls, mud : NOU-BF |
49
2%
|
18
NaN
|
4
NaN
|
6
NaN
|
52
NaN
|
| MHCM walls, mud : OUA-BF |
174
7.2%
|
67
NaN
|
29
NaN
|
37
NaN
|
283
NaN
|
| MHCM walls, mud : DA-1-SE |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
170
NaN
|
| MHCM walls, mud : DA-2-SE |
4
0.2%
|
0
NaN
|
1
NaN
|
0
NaN
|
279
NaN
|
| MHCM walls, brick : NOU-BF |
153
6.3%
|
70
NaN
|
32
NaN
|
17
NaN
|
129
NaN
|
| MHCM walls, brick : OUA-BF |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
6
NaN
|
| MHCM walls, brick : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
210
NaN
|
| MHCM walls, brick : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
110
NaN
|
| MHCM walls, cement/plaster : NOU-BF |
6
0.2%
|
1
NaN
|
1
NaN
|
0
NaN
|
12
NaN
|
| MHCM walls, cement/plaster : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
| MHCM walls, cement/plaster : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM walls, cement/plaster : DA-2-SE |
2
0.1%
|
0
NaN
|
0
NaN
|
0
NaN
|
114
NaN
|
| MHCM walls, cement/paint : NOU-BF |
21
0.9%
|
5
NaN
|
3
NaN
|
0
NaN
|
29
NaN
|
| MHCM walls, cement/paint : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM walls, cement/paint : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
220
NaN
|
| MHCM walls, cement/paint : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
87
NaN
|
| MHCM walls, other : NOU-BF |
0
0%
|
2
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM walls, other : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM walls, other : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM walls, other : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
10
NaN
|
| MHCM floor, natural floor : NOU-BF |
114
4.7%
|
66
NaN
|
17
NaN
|
11
NaN
|
90
NaN
|
| MHCM floor, natural floor : OUA-BF |
156
6.4%
|
57
NaN
|
25
NaN
|
32
NaN
|
255
NaN
|
| MHCM floor, natural floor : DA-1-SE |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
118
NaN
|
| MHCM floor, natural floor : DA-2-SE |
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
332
NaN
|
| MHCM floor, rudimentary floor : NOU-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, rudimentary floor : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, rudimentary floor : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, rudimentary floor : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
16
NaN
|
| MHCM floor, vinyl or asphalt strips : NOU-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, vinyl or asphalt strips : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, vinyl or asphalt strips : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
95
NaN
|
| MHCM floor, vinyl or asphalt strips : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, ceramic tiles : NOU-BF |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
| MHCM floor, ceramic tiles : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, ceramic tiles : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
36
NaN
|
| MHCM floor, ceramic tiles : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
| MHCM floor, cement : NOU-BF |
114
4.7%
|
30
NaN
|
23
NaN
|
12
NaN
|
129
NaN
|
| MHCM floor, cement : OUA-BF |
19
0.8%
|
10
NaN
|
4
NaN
|
5
NaN
|
37
NaN
|
| MHCM floor, cement : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
349
NaN
|
| MHCM floor, cement : DA-2-SE |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
247
NaN
|
| MHCM floor, carpet : NOU-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, carpet : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, carpet : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
| MHCM floor, carpet : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MHCM floor, other : NOU-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, other : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, other : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM floor, other : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MHCM roof, glass/palm : NOU-BF |
5
0.2%
|
5
NaN
|
0
NaN
|
0
NaN
|
5
NaN
|
| MHCM roof, glass/palm : OUA-BF |
52
2.1%
|
27
NaN
|
9
NaN
|
12
NaN
|
68
NaN
|
| MHCM roof, glass/palm : DA-1-SE |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
100
NaN
|
| MHCM roof, glass/palm : DA-2-SE |
4
0.2%
|
0
NaN
|
1
NaN
|
1
NaN
|
300
NaN
|
| MHCM roof, iron sheet : NOU-BF |
121
5%
|
34
NaN
|
21
NaN
|
7
NaN
|
128
NaN
|
| MHCM roof, iron sheet : OUA-BF |
123
5.1%
|
40
NaN
|
20
NaN
|
25
NaN
|
224
NaN
|
| MHCM roof, iron sheet : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
451
NaN
|
| MHCM roof, iron sheet : DA-2-SE |
2
0.1%
|
0
NaN
|
0
NaN
|
0
NaN
|
297
NaN
|
| MHCM roof, tiles : NOU-BF |
103
4.3%
|
57
NaN
|
19
NaN
|
16
NaN
|
89
NaN
|
| MHCM roof, tiles : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM roof, tiles : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
| MHCM roof, tiles : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
| MHCM windows/eaves, closed : NOU-BF |
79
3.3%
|
26
NaN
|
16
NaN
|
5
NaN
|
84
NaN
|
| MHCM windows/eaves, closed : OUA-BF |
80
3.3%
|
32
NaN
|
17
NaN
|
15
NaN
|
116
NaN
|
| MHCM windows/eaves, closed : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
28
NaN
|
| MHCM windows/eaves, closed : DA-2-SE |
5
0.2%
|
0
NaN
|
1
NaN
|
1
NaN
|
463
NaN
|
| MHCM windows/eaves, open : NOU-BF |
102
4.2%
|
47
NaN
|
10
NaN
|
12
NaN
|
87
NaN
|
| MHCM windows/eaves, open : OUA-BF |
49
2%
|
12
NaN
|
6
NaN
|
13
NaN
|
90
NaN
|
| MHCM windows/eaves, open : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
88
NaN
|
| MHCM windows/eaves, open : DA-2-SE |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
136
NaN
|
| MHCM windows/eaves, partially open : NOU-BF |
48
2%
|
23
NaN
|
14
NaN
|
6
NaN
|
51
NaN
|
| MHCM windows/eaves, partially open : OUA-BF |
46
1.9%
|
23
NaN
|
6
NaN
|
9
NaN
|
86
NaN
|
| MHCM windows/eaves, partially open : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
92
NaN
|
| MHCM windows/eaves, partially open : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MHCM nets, not present : NOU-BF |
224
9.3%
|
95
NaN
|
40
NaN
|
23
NaN
|
215
NaN
|
| MHCM nets, not present : OUA-BF |
173
7.1%
|
66
NaN
|
29
NaN
|
37
NaN
|
291
NaN
|
| MHCM nets, not present : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
206
NaN
|
| MHCM nets, not present : DA-2-SE |
6
0.2%
|
0
NaN
|
1
NaN
|
1
NaN
|
598
NaN
|
| MHCM nets, present on all windows : NOU-BF |
4
0.2%
|
1
NaN
|
0
NaN
|
0
NaN
|
5
NaN
|
| MHCM nets, present on all windows : OUA-BF |
1
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MHCM nets, present on all windows : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
| MHCM nets, present on all windows : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
| MHCM nets, present on some windows : NOU-BF |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
| MHCM nets, present on some windows : OUA-BF |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MHCM nets, present on some windows : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MHCM nets, present on some windows : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MSDW, bottled water : NOU-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MSDW, bottled water : OUA-BF |
1
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MSDW, bottled water : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MSDW, bottled water : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MSDW, closed water source : NOU-BF |
146
6%
|
57
NaN
|
24
NaN
|
9
NaN
|
116
NaN
|
| MSDW, closed water source : OUA-BF |
152
6.3%
|
50
NaN
|
25
NaN
|
31
NaN
|
247
NaN
|
| MSDW, closed water source : DA-1-SE |
1
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
465
NaN
|
| MSDW, closed water source : DA-2-SE |
2
0.1%
|
0
NaN
|
0
NaN
|
1
NaN
|
379
NaN
|
| MSDW, open water source : NOU-BF |
83
3.4%
|
39
NaN
|
16
NaN
|
14
NaN
|
105
NaN
|
| MSDW, open water source : OUA-BF |
22
0.9%
|
17
NaN
|
4
NaN
|
6
NaN
|
44
NaN
|
| MSDW, open water source : DA-1-SE |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
135
NaN
|
| MSDW, open water source : DA-2-SE |
4
0.2%
|
0
NaN
|
1
NaN
|
0
NaN
|
221
NaN
|
| MSDW, not applicable : NOU-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
| MSDW, not applicable : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MSDW, not applicable : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| MSDW, not applicable : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| PE, Yes : NOU-BF |
46
1.9%
|
11
NaN
|
7
NaN
|
3
NaN
|
76
NaN
|
| PE, Yes : OUA-BF |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| PE, Yes : DA-1-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
164
NaN
|
| PE, Yes : DA-2-SE |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| PE, No : NOU-BF |
183
7.6%
|
85
NaN
|
33
NaN
|
20
NaN
|
146
NaN
|
| PE, No : OUA-BF |
175
7.2%
|
67
NaN
|
29
NaN
|
37
NaN
|
292
NaN
|
| PE, No : DA-1-SE |
1
0%
|
1
NaN
|
0
NaN
|
1
NaN
|
436
NaN
|
| PE, No : DA-2-SE |
6
0.2%
|
0
NaN
|
1
NaN
|
1
NaN
|
546
NaN
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | As planned per protocol, other (non-serious) adverse events were not collected. | |
| Arm/Group Title | Overall Study Group | |
| Arm/Group Description | Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy. | |
All Cause Mortality |
||
| Overall Study Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2421 (0%) | |
Serious Adverse Events |
||
| Overall Study Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2421 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Overall Study Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
- 200187