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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02207816
• Date of registration: 31/07/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: 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
• Scientific 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
• Date of first enrolment: September 18, 2014
• Target sample size: 3084
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02207816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Burkina Faso, Kenya, Tanzania

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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.



Age minimum: 42 Months
Age maximum: 9 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)

Biological: Cell-culture rabies vaccine (MALARIA-055 PRI)

Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)

Procedure: Blood sampling

Biological: TritanrixHepB/Hib (MALARIA-055 PRI)

Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)

Primary Outcome(s)

Incidence of Severe Malaria Meeting Case Definition 1 [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Incidence of Severe Malaria Meeting Case Definition 2. [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Secondary Outcome(s)

Incidence of Clinical Malaria Meeting Case Definition [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Fatal Malaria Meeting Case Definition 1. [Time Frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).]

Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) [Time Frame: 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)]

Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) [Time Frame: At Years 1, 2 and 3]

Number of Subjects With Cerebral Malaria [Time Frame: 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. [Time Frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).]

Incidence of Clinical Malaria Meeting Case Definition [Time Frame: 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) SAEs [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Fatal Malaria Meeting Case Definition 1. [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. [Time Frame: 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. [Time Frame: 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. [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Meningitis SAEs [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) [Time Frame: At Years 1, 2 and 3]

Incidence of Severe Malaria Meeting Case Definition 1. [Time Frame: 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. [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Incidence of Severe Malaria Meeting Case Definition 2. [Time Frame: 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) [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Fatal Malaria Meeting Case Definition 2. [Time Frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)]

Number of Subjects With Prevalent Parasitemia [Time Frame: At Years 1, 2 and 3]

Secondary ID(s)

200599

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02207816