Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197067
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2005-09-13
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals Candidate Vaccines RTSSAS02D 05 mL Dose and RTSSAS02A 025 mL Dose Administered IM According to a 0 1 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Bridging Study to Evaluate the Safety and Immunogenicity of GSK Biologicals Candidate Vaccines RTSSAS02D 05 mL Dose and RTSSAS02A 025 mL Dose Administered According to a 0 1 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTSSAS02 for the routine immunization of infants and children living in malaria endemic areas The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum and also would provide protection against infection with hepatitis B virus Studies conducted using the formulation RTSSAS02A 025 ml dose in children and adults have shown to be safe Currently all intramuscular vaccines in the EPI schedule are administered at a dose volume of 05 ml and in this context a new variant of RTSSAS02D 05 ml dose formulation has been composed which has the same active constituents in the same quantities as in a 025 ml dose of RTSSAS02A In this study RTSSAS02D 05 ml dose was compared to the existing formulation RTSSAS02A 025 ml dose
Detailed Description:
Children participating in this study will either receive RTSSAS02D 05 ml dose or RTSSAS02A 025 ml dose intramuscularly according to 0 1 2 months schedule The children will be followed-up throughout the study period to record safety events Blood samples will be collected at defined time points to assess the subjects immune response to the relevant immunological indicators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None