An Epidemiology Study to Assess Plasmodium Falciparum Parasite Prevalence and Malaria Control Measures in Catchment Areas of Two Interventional Studies Pre- and Post RTS,S/AS01E Introduction (EPI MAL-002 and EPI-MAL-003) to Assess, in Field Conditions, Vaccine Benefit: Risk in Children in Sub Saharan Africa
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54,115
- 试验地点
- 12
- 主要终点
- Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group
研究概览
简要总结
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives were to produce longitudinal estimates of parasite prevalence in humans and to record the usage of malaria control measures in areas where the EPI-MAL-002 and EPI-MAL-003 studies were conducted.
详细描述
This study involved 10 annual cross-sectional surveys conducted during malaria peak transmission seasons. The surveys provided point estimates of parasite prevalence and subsequently enabled a longitudinal assessment of the level of endemicity in each area covered by EPI-MAL-002 and EPI-MAL-003. The study was conducted in parallel with EPI-MAL-002 and EPI-MAL-003 to assess parasite prevalence and malaria control measures before (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction.
By taking into account variations in malaria transmission intensity (MTI) and malaria control intervention coverage, it enabled a more complete assessment of the benefits and risks of the vaccine introduction, and thereby provided greater insight into the potential vaccine impact in EPI-MAL-002/-003 by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assisted in the generalisation of results to other populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, could and would comply with the requirements of the protocol.
- •A male or female aged 6 months to under 10 years at the time of the survey.
- •Signed informed consent or thumb-printed and witnessed informed consent was obtained from the parent(s)/LAR(s) of the child.
排除标准
- •Child was in care.
- •Had current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
结局指标
主要结局
Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group
时间窗: At Day 1 (survey completion visit)
The number of participants was summarized by the WHO age group (0.5-1 year \[Y\] and 2-9Y) and by center number/ country \[Burkina Faso (BF), Senegal (SN), Tanzania (TZ), Kenya (KE), Ghana (GH), Malawi (MA)\]/ city. Unexposed (UNEXP) sites are the ones in which the RTS,S vaccine was not planned to be implemented during the course of the study however, vaccinated participants could still have been randomly selected in this population if vaccination happened in an exposed (EXP) site, due to cross-site migration. The infection was identified using a blood smear slide and determined using microscopy.
Number of Participants Infected With P. Falciparum by Joint Technical Expert Group (JTEG) Age Group
时间窗: At Day 1 (survey completion visit)
The number of participants was summarized by the JTEG age group (0.5-4Y and 5-9Y) by center number/ country \[BF, SN, TZ, KE, GH, MA\]/ city. UNEXP sites are the ones in which the RTS,S vaccine was not planned to be implemented during the course of the study however, vaccinated participants could still have been randomly selected in this population if vaccination happened in an EXP site, due to cross-site migration. The infection was identified using a blood smear slide and determined using microscopy.
Number of Participants Using Malaria Control Interventions: Bednet Usage and Type of Bednet
时间窗: At Day 1 (survey completion visit)
The number of participants using malaria control interventions was summarized by: participants sleeping under a mosquito net the night before their visit, participants who have a new bednet (less than 1 year), participants who have a impregnated bednet (dipped in liquid to repel mosquitos after purchase), participants who have a pierced/torn bednet, participants with bednets classified by hole size (defined as holes big enough to let one finger go through) and number of holes (less than \[\<\] 5 holes, more or equal \[\>=\] to 5 holes, not applicable \[NA\] which is a participant who did not sleep under a bed net, missing confirmed \[MC\] which is a participant who slept under a mosquito net but who didn't answer to the question on holes).
Number of Participants Using Malaria Control Interventions: Mosquito Coils, Insecticide Sprays, Commercial Repellants, Traditional Repellants and Indoor Residual Sprays
时间窗: At Day 1 (survey completion visit)
The number of participants using malaria control interventions was summarized by: mosquito coils, insecticide sprays, commercial repellants, traditional repellants and indoor residual sprays (in the past 12 months, 1 to 12 months, NA \[the participant didn't use the residual spray\], missing \[participant used spray but didn't answer to how long ago\]).
次要结局
- Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status(At Day 1 (survey completion visit))
- Number of Participants Infected With Plasmodium Species Other Than P. Falciparum(At Day 1 (survey completion visit))
- Number of Participants Who Received Dose 3 of the Diphtheria, Tetanus, Pertussis/ Hepatitis B/ Haemophilus Influenzae Type b (DTP/HepB/Hib) Vaccine or Dose 1 of the Measles Vaccine(At Day 1 (survey completion visit))
- Number of Participants Who Received Anti-malarial Therapy or Any Other Medication Within 14 Days Prior to the Study Visit(Up to 14 days prior to the study visit at Day 1)
- Number of Participants With Measured Fever at the Time of Their Study Visit(At Day 1 (survey completion visit))
- Number of Participants With Reported Fever in the 24 Hours Prior to Their Study Visit(Up to 24 hours prior to their study visit at Day 1)
- Number of Participants Demonstrating Care-seeking Behavior Following Reported Fever or Malaria up to 14 Days Prior to Their Study Visit(Up to 14 days prior to their study visit at Day 1)
- Number of Participants in Each Geo-referenced Segment(At Day 1 (survey completion visit))
- Number of Participants Experiencing Malaria Risk Factors Categorized by the Number of Participants Living in the Same House (by Parasite Density)(At Day 1 (survey completion visit))
- Number of Participants Experiencing Malaria Risk Categorized by Location (by Parasite Density)(At Day 1 (survey completion visit))
- Number of Participants Experiencing Malaria Risk Factors Categorized by House Information (by Parasite Density)(At Day 1 (survey completion visit))