Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197028
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2005-09-13
Brief Title:
Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase IIIb Randomized Double-blind Controlled Study of the Safety Immunogenicity and Proof-of-concept of RTSSAS02D a Candidate Malaria Vaccine in Infants Living in a Malaria-endemic Region
Status:
COMPLETED
Status Verified Date:
2017-04
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 Program for Appropriate Technology in Health PATH Malaria Vaccine Initiative a candidate malaria vaccine 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 The vaccine would also provide protection against infection with hepatitis B virus HBV
This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate 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 order to integrate the malaria vaccine into the Expanded Program on Immunization EPI regimen in malaria-endemic regions for this trial a 05 ml dose of GSK 257049 vaccine has been developed The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate 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 order to integrate the malaria vaccine into the Expanded Program on Immunization EPI regimen in malaria-endemic regions for this trial a 05 ml dose of GSK 257049 vaccine has been developed The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
All infants participating in this phase IIIb study will receive TETRActHib a licensed diphtheria-tetanus-pertussis Haemophilus influenzae vaccine manufactured by Aventis Pasteur by IM injection in their right thigh at 8 12 and 16 weeks They will be randomized to receive either the candidate malaria vaccine GSK 257049 vaccine 05 ml dose or Engerix-B a licensed hepatitis B vaccine manufactured by GSK Biologicals by IM injection in their left thigh at 10 14 18 weeks Infants will be followed-up daily for 7 days after each vaccine dose for evaluation of safety and reactogenicity There will be a 14-day follow-up period after each dose of TETRActHib and after Dose 1 and Dose 2 of GSK 257049 vaccine or Engerix-B and a one month follow-up period after Dose 3 of GSK 257049 vaccine or Engerix-B for reporting unsolicited symptoms Serious adverse events will be recorded throughout the 14 month study period A small amount of blood 2 ml 12 teaspoon will be obtained at four different time points to measure the immune response elicited by the vaccines administered during this study period Preliminary indication of vaccine efficacy in this age group will be established by actively monitoring for infection with Plasmodium falciparum
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