An extension to study MALARIA-055 PRI (NCT00866619) to evaluate the long-term efficacy, safety and immunogenicity of GSK Biologicals’ candidate malaria vaccine in infants and children in Africa
Trial overview
Incidence of severe malaria meeting case definition 1
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Incidence of severe malaria meeting case definition 2.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Incidence of severe malaria meeting case definition 1
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Incidence of severe malaria meeting case definition 2.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Incidence of clinical malaria meeting case definition
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with malaria hospitalization meeting case definition 1.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with malaria hospitalization meeting case definition 2.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with cerebral malaria meeting both case definitions.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with fatal malaria meeting case definition 1.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with fatal malaria meeting case definition 2.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with prevalent parasitemia
Timeframe: At Years 1, 2 and 3
Number of subjects with prevalent severe anemia
Timeframe: At Years 1, 2 and 3
Number of subjects with prevalent moderate anemia
Timeframe: At Years 1, 2 and 3
Incidence of severe malaria meeting case definition 1.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Incidence of severe malaria meeting case definition 2.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Incidence of clinical malaria meeting case definition
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Number of subjects with malaria hospitalization meeting case definition 1.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Number of subjects with malaria hospitalization meeting case definition 2.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects with cerebral malaria
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects with fatal malaria meeting case definition 1.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects with fatal malaria meeting case definition 2.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Level of hemoglobin, in both age categories (6-12 weeks and 5-17 months)
Timeframe: At Years 1, 2 and 3
Number of subjects reporting any, related, malaria and fatal serious adverse events (SAEs)
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects reporting any potential immune-mediated disorders (pIMDs) SAEs
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with meningitis SAEs
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Antibody concentrations against against Plasmodium falciparum circumsporozoite (anti-CS)
Timeframe: At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)
Incidence of clinical malaria meeting case definition 1
Timeframe: From Year 0 to Year 3
Incidence of clinical malaria meeting case definition 1
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Number of subjects reporting any potential immune-mediated disorders (pIMDs)
Timeframe: From Year 0 to Year 3
Antibody titers against against Plasmodium falciparum circumsporozoite (anti-CS)
Timeframe: At Years 1, 2, 3 and 4 (of Malaria-055) and Years 1, 2 and 3 (of Malaria-076)
Number of subjects with malaria hospitalization meeting case definition 1.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with malaria hospitalization meeting case definition 2.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with cerebral malaria meeting both case definitions.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with fatal malaria meeting case definition 1.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with fatal malaria meeting case definition 2.
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with malaria hospitalization meeting case definition 1.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Number of subjects with malaria hospitalization meeting case definition 2.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects with cerebral malaria
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects with fatal malaria meeting case definition 1.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects with fatal malaria meeting case definition 2.
Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Number of subjects reporting any, related, malaria and fatal serious adverse events (SAEs)
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Number of subjects with meningitis SAEs
Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Participation criteria
- Subjects’ parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.
- Child in care.
- Use of any investigational or non-registered product or planned use during the study period.
- Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Subjects’ parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Use of any investigational or non-registered product or planned use during the study period.
Child in care.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.