Last updated: 04/08/2026 14:20:32
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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study 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:
Occurrence of P. falciparum haplotype infection at participant level
Timeframe: 08 Oct 2021 – 08 Apr 2025
Occurrence of P. falciparum haplotype infection at haplotype level
Timeframe: 08 Oct 2021 – 08 Apr 2025
Secondary outcomes:
Occurrence of specific P. falciparum haplotype infection at participant level by gender, age group and RTS,S/AS01E vaccination status
Timeframe: 08 Oct 2021 – 08 Apr 2025
Occurrence of specific P. falciparum haplotype infection at haplotypes level by gender, age group and RTS,S/AS01E vaccination status
Timeframe: 08 Oct 2021 – 08 Apr 2025
Trend estimations of specific P. falciparum haplotype infection at participant level by RTS,S/AS01E vaccination status
Timeframe: 08 Oct 2021 – 08 Apr 2025
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2024-31-10
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 October 2024
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
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-31-10
Actual study completion date
2024-31-10
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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