Last updated: 07/17/2024 17:00:59

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

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GSK study ID
200599
See study documents
Clinicaltrials.gov ID
NCT02207816
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Extension to study MALARIA-055 PRI (NCT00866619) for evaluation of long-term efficacy, safety and immunogenicity of GSK Biologicals’ candidate malaria vaccine (SB257049) in infants and children in Africa
Trial description: The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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)

Secondary outcomes:

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)

Interventions:
  • Procedure/surgery: Blood sampling
  • Biological/vaccine: Malaria Vaccine 257049 (MALARIA-055 PRI)
  • Biological/vaccine: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
  • Biological/vaccine: Cell-culture rabies vaccine (MALARIA-055 PRI)
  • Biological/vaccine: TritanrixHepB/Hib (MALARIA-055 PRI)
  • Biological/vaccine: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
    • Enrollment:
    3084
    Primary completion date:
    2017-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Tinto H et al. (2019) Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. Lancet Infect Dis. 19(8):821-832. doi: 10.1016/S1473-3099(19)30300-7.
    Medical condition
    Malaria
    Product
    SB257049
    Collaborators
    Not applicable
    Study date(s)
    September 2014 to January 2017
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    42 months - 9 years
    Accepts healthy volunteers
    Yes
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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.
      • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
    Exclusion criteria:

      Child in care.

      • Use of any investigational or non-registered product or planned use during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Kisumu, Kenya
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ouagadougou, Burkina Faso
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tanga, Tanzania
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2017-31-01
    Actual study completion date
    2017-31-01

    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.

    Additional information about the trial

    Additional information
    Not applicable
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