N/A N=21,618 Other

Epidemiology Study of Malaria Transmission Intensity in Africa

Malaria · Malaria Vaccines

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View on ClinicalTrials.gov: NCT01190202 ↗

Enrolled (actual)

21,618

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey — 720; 574; 605; 345 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood sampling (Procedure); Assessment of body temperature (Procedure)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey	720; 574; 605; 345; 446; 469	—
SECONDARY Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey	21; 38; 41; 25; 94; 75	—
SECONDARY Number of Subjects With Anemia and Severe Anemia for Each Survey	1974; 2025; 1974; 871; 4; 2	—
SECONDARY Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density	22; 9; 2; 12; 262; 351	—
SECONDARY Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density	14; 6; 2; 5; 257; 269	—
SECONDARY Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density	17; 13; 3; 9; 267; 262	—
SECONDARY Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density	5; 2; 1; 5; 71; 163	—
SECONDARY Mean Number of Days With Malaria Treatment at Survey 1	2.6; 3.7; 2.5; 3.1; 3.1; 2.0	—
SECONDARY Mean Number of Days With Malaria Treatment at Survey 2	2.8; 5.7; 3.5; 2.0; 3.1; 2.8	—
SECONDARY Mean Number of Days With Malaria Treatment at Survey 3	3.0; 3.3; 2.3; 2.2; 3.1; 3.9	—
SECONDARY Mean Number of Days With Malaria Treatment at Survey 4	2.3; 3.0; 3.0; 1.0; 3.1; 3.0	—
SECONDARY Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1	71; 53; 21; 60; 361; 302	—
SECONDARY Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2	41; 23; 15; 35; 357; 242	—
SECONDARY Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3	60; 44; 28; 44; 360; 219	—
SECONDARY Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4	39; 18; 5; 27; 115; 129	—
SECONDARY Mean Number of Days With Fever at Survey 1	2.5; 2.6; 2.1; 2.5; 2.3; 2.2	—
SECONDARY Mean Number of Days With Fever at Survey 2	2.1; 2.7; 1.4; 2.0; 2.4; 2.5	—
SECONDARY Mean Number of Days With Fever at Survey 3	2.3; 2.4; 2.2; 2.1; 2.5; 2.3	—
SECONDARY Mean Number of Days With Fever at Survey 4	2.2; 2.4; 1.6; 2.2; 2.7; 2.0	—
SECONDARY Axillary Temperature at Visit in Survey 1	36.65; 36.64; 36.72; 37.04; 36.55; 36.56	—
SECONDARY Axillary Temperature at Visit in Survey 2	36.69; 36.75; 36.86; 37.41; 36.60; 36.70	—
SECONDARY Axillary Temperature at Visit in Survey 3	36.47; 36.66; 36.68; 36.97; 36.54; 36.56	—
SECONDARY Axillary Temperature at Visit in Survey 4	36.51; 36.51; 36.95; 37.16; 36.40; 36.53	—
SECONDARY Number of Subjects Living in the Same House at Survey 1	34; 13; 3; 2; 78; 32	—
SECONDARY Number of Subjects Living in the Same House at Survey 2	27; 18; 8; 2; 59; 33	—
SECONDARY Number of Subjects Living in the Same House at Survey 3	31; 16; 7; 11; 63; 31	—
SECONDARY Number of Subjects Living in the Same House at Survey 4	28; 21; 2; 7; 42; 24	—
SECONDARY Mean Number of Subjects Living in the Same House at Survey 1	6.4; 6.3; 6.5; 5.8; 6.5; 6.9	—
SECONDARY Mean Number of Subjects Living in the Same House at Survey 2	5.1; 5.0; 5.1; 5.4; 5.8; 5.5	—
SECONDARY Mean Number of Subjects Living in the Same House at Survey 3	5.1; 5.4; 5.1; 5.0; 5.6; 5.9	—
SECONDARY Mean Number of Subjects Living in the Same House at Survey 4	5.4; 5.1; 5.5; 5.2; 6.6; 6.5	—
SECONDARY Number of Subjects by Localisation and Type of Location at Survey 1	309; 136; 45; 106; 1415; 39	—
SECONDARY Number of Subjects by Localisation and Type of Location at Survey 2	212; 120; 51; 60; 1377; 44	—
SECONDARY Number of Subjects by Localisation and Type of Location at Survey 3	234; 146; 65; 82; 1531; 30	—
SECONDARY Number of Subjects by Localisation and Type of Location at Survey 4	153; 102; 20; 53; 536; 15	—
SECONDARY Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1	97; 62; 34; 84; 869; 190	—
SECONDARY Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2	49; 30; 15; 29; 1010; 163	—
SECONDARY Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3	65; 42; 19; 33; 969; 143	—
SECONDARY Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4	33; 14; 2; 14; 127; 92	—
SECONDARY Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1	112; 53; 22; 44; 453; 231	—
SECONDARY Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2	52; 32; 16; 23; 509; 201	—
SECONDARY Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3	55; 35; 12; 26; 464; 214	—
SECONDARY Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4	51; 29; 6; 17; 161; 111	—
SECONDARY Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1	1; 0; 0; 0; 22; 246	—
SECONDARY Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2	1; 0; 0; 0; 4; 207	—
SECONDARY Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3	0; 0; 0; 1; 26; 185	—
SECONDARY Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4	0; 0; 0; 0; 1; 139	—
SECONDARY Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey	433; 398; 348; 239; 2767; 2799	—
SECONDARY Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1	19; 21; 1; 3181; 1592; 1587	—
SECONDARY Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2	32; 27; 2; 3165; 1600; 1585	—
SECONDARY Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3	48; 27; 0; 3145; 1585; 1595	—
SECONDARY Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4	32; 28; 0; 1161; 578; 600	—
SECONDARY Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey	0; 0; 0; 0	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01190202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.