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

PHASE3CompletedINTERVENTIONAL
Enrollment

3,084

Participants

Timeline

Start Date

September 18, 2014

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Malaria
Interventions
PROCEDURE

Blood sampling

Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.

BIOLOGICAL

Malaria Vaccine 257049 (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

Cell-culture rabies vaccine (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

TritanrixHepB/Hib (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

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

Administered orally, during the MALARIA-055 study (NCT00866619).

Trial Locations (3)

Unknown

GSK Investigational Site, Ouagadougou

GSK Investigational Site, Kisumu

GSK Investigational Site, Tanga

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY