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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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ClinicalTrials.gov Identifier: NCT02207816
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malaria Procedure: Blood sampling Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3084 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 18, 2014
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: R3R Group
Infants/children assigned to the R3R group received 3 doses of RTS,S/AS01E on a 0-, 1-, 2-month schedule, and a booster dose of RTS,S/AS01E at Month 20 during the primary study MALARIA-055 PRI (NCT00866619).
Procedure: Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.

Active Comparator: R3C Group
Infants/children assigned to the R3C group received 3 doses of RTS,S/AS01E on 0-, 1-, 2-month schedule, and a dose of comparator vaccine at Month 20 during the primary study MALARIA-055 PRI (NCT00866619).
Procedure: Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.

Active Comparator: C3C Group
Infants/children assigned to the C3C group received 3 doses of a comparator vaccine on 0-, 1-, 2-month schedule, and a dose of comparator vaccine at Month 20 during the primary study MALARIA-055 PRI (NCT00866619).
Procedure: Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.




Primary Outcome Measures :
  1. Occurrence of severe malaria meeting the primary case definition. [ Time Frame: Starting January 2014 until the end of the 3-year follow-up period (Year 3). ]

Secondary Outcome Measures :
  1. Occurrence of clinical malaria meeting the primary and secondary case definitions. [ Time Frame: Starting January 2014 until the end of the 3-year follow-up period (Year 3). ]
  2. Occurrence of malaria hospitalization meeting each of the case definitions. [ Time Frame: Starting January 2014 until the end of the 3-year follow-up period (Year 3). ]
  3. Prevalence of parasitemia, in both age categories (6-12 weeks and 5-17 months). [ Time Frame: At three annual timepoints (Year 1, 2 and 3). ]
  4. Prevalence of anemia, in both age categories (6-12 weeks and 5-17 months). [ Time Frame: At three annual timepoints (Year 1, 2 and 3). ]
  5. Level of hemoglobin, in both age categories (6-12 weeks and 5-17 months). [ Time Frame: At three annual timepoints (Year 1, 2 and 3). ]
  6. Occurrence of severe malaria meeting the primary and secondary case definitions, in both age categories (6-12 weeks and 5-17 months). [ Time Frame: Starting at the beginning of the primary study (MALARIA-055 PRI NCT00866619; Visit 2) until the end of the follow-up period (Year 3). ]
  7. Occurrence of clinical malaria meeting the primary and secondary case definitions, in both age categories (6-12 weeks and 5-17 months). [ Time Frame: Starting at the beginning of the primary study (MALARIA-055 PRI NCT00866619; Visit 2) until the end of the follow-up period (Year 3). ]
  8. Occurrence of malaria hospitalization meeting all case definitions, in both age categories (6-12 weeks and 5-17 months). [ Time Frame: Starting at the beginning of the primary study (MALARIA-055 PRI NCT00866619; Visit 2) until the end of the follow-up period (Year 3). ]
  9. Occurrence of the following reported serious adverse events (SAEs): fatalities, related SAEs (related to vaccine administration in the primary study MALARIA-055 PRI NCT00866619 and to study participation), malaria hospitalization, pIMDs, and meningitis. [ Time Frame: Starting January 2014 until the end of the 3-year follow-up period (Year 3). ]
  10. Annual anti- circumsporozoite antibody titers for children of both age categories (6-12 weeks and 5-17 months). [ Time Frame: At three annual time points (Year 1, 2 and 3). ]


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Ages Eligible for Study:   42 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207816


Locations
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Burkina Faso
GSK Investigational Site
Ouagadougou, Burkina Faso
Kenya
GSK Investigational Site
Kisumu, Kenya
Tanzania
GSK Investigational Site
Tanga, Tanzania
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02207816     History of Changes
Other Study ID Numbers: 200599
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Infants
Efficacy
Children
Malaria
Plasmodium falciparum
Safety
Surveillance
Immunogenicity
RTS,S/AS01E
Africa

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs