Last updated: 02/20/2024 09:01:18
An ancillary study of EPI-MAL-005 to monitor the genetic diversity in circumsporozoite sequences in the Plasmodium falciparum parasite population before and after vaccine implementation in children aged 6 months to less than 5 yearsEPI-MALARIA-010 VS AME
GSK study ID
205071
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A phase IV, longitudinal, cross-sectional, retrospective, ancillary epidemiology study of the EPI-MAL-005 study to evaluate the genetic diversity in the Plasmodium falciparum parasite circumsporozoite sequences before and after the implementation of the RTS,S/AS01E vaccine in malaria-positive subjects ranging from 6 months to less than 5 years of age
Trial description: The RTS,S/AS01E vaccine has been developed for routine immunization of infants and children living in malaria-endemic countries of Sub-Saharan Africa. The aim of this retrospective, ancillary epidemiology study is to monitor the genetic diversity in circumsporozoite sequences in the Plasmodium falciparum (P. falciparum) parasite in malaria-positive subjects aged 6 months to <5 years vaccinated or not with RTS,S/AS01E.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence of specific P. falciparum haplotype infections among subjects infected or not with P. falciparum, vaccinated or not with RTS,S/AS01E per study site
Timeframe: From Year 1 (Survey 1) to Year 7 (Survey 7)
Frequency of specific P. falciparum haplotype infections among the individual malaria clones in subjects vaccinated or not with RTS,S/AS01E per study site
Timeframe: From Year 1 (Survey 1) to Year 7 (Survey 7)
Secondary outcomes:
Prevalence of specific P. falciparum haplotype infections by age group, gender and RTS,S/AS01E vaccination status per study site
Timeframe: From Year 1 (Survey 1) to Year 7 (Survey 7)
Frequency of specific P. falciparum haplotype infections by age group, gender and RTS,S/AS01E vaccination status per study site
Timeframe: From Year 1 (Survey 1) to Year 7 (Survey 7)
Trends in longitudinal prevalence of specific P. falciparum haplotypes among subjects infected or not with P. falciparum, vaccinated or not with RTS,S/AS01E
Timeframe: From Year 1 (Survey 1) to Year 7 (Survey 7)
Trends in longitudinal frequency of specific P. falciparum haplotypes among the individual malaria clones in subjects vaccinated or not with RTS,S/AS01E
Timeframe: From Year 1 (Survey 1) to Year 7 (Survey 7)
Interventions:
Not applicable
Enrollment:
5600
Primary completion date:
2025-31-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
October 2021 to January 2025
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6 Months - 5 Years
Accepts healthy volunteers
Yes
- Subjects aged 6 months to <5 years enrolled in the EPI-MAL-005 study at 2 sites (1 site in Eastern Africa and 1 site in Western Africa), fulfilling inclusion and exclusion criteria of the EPI-MAL-005 study.
- Subjects whose parent(s)/ Legally Acceptable Representative(s) have provided informed consent for the use of collected blood samples in further research as explained in the original informed consent form of the EPI-MAL-005 study.
- All eligible subjects from the EPI-MAL-005 study that will be 5 years of age or over at time of the annual survey (i.e., at the time of sample collection) will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects aged 6 months to <5 years enrolled in the EPI-MAL-005 study at 2 sites (1 site in Eastern Africa and 1 site in Western Africa), fulfilling inclusion and exclusion criteria of the EPI-MAL-005 study.
- Subjects whose parent(s)/ Legally Acceptable Representative(s) have provided informed consent for the use of collected blood samples in further research as explained in the original informed consent form of the EPI-MAL-005 study.
Exclusion criteria:
- All eligible subjects from the EPI-MAL-005 study that will be 5 years of age or over at time of the annual survey (i.e., at the time of sample collection) will be excluded.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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