Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323622
Status:
COMPLETED
Last Update Posted:
2016-12-09
First Post:
2005-09-08
Brief Title:
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Study for a 2-year Period to Confirm the Safety and Immunogenicity of the Candidate Malaria Vaccine RTSSAS02A in Mozambican Children Aged 1 to 4 Years at the Time of First Vaccine Dose
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The RTSSAS02A vaccine or GSK 257049 vaccine GSK Biologicals candidate Plasmodium falciparum P falciparum malaria vaccine is being developed 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 P falciparum The vaccine would also provide protection against infection with hepatitis B virus HBV
This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique there the vaccine demonstrated approximately 30 efficacy against clinical episodes of malaria and approximately 58 efficacy against severe malaria disease
In this study the children from Mozambique NCT NCT00197041 are followed-up to assess the safety immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1
This protocol posting deals with objectives outcome measures of the extension phase at year 2 During this extension study no new subjects will be recruited and no vaccine will be administered
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique there the vaccine demonstrated approximately 30 efficacy against clinical episodes of malaria and approximately 58 efficacy against severe malaria disease
In this study the children from Mozambique NCT NCT00197041 are followed-up to assess the safety immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1
This protocol posting deals with objectives outcome measures of the extension phase at year 2 During this extension study no new subjects will be recruited and no vaccine will be administered
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
None
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