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Home > Protocol Summaries: Compounds > Hepatitis B Vaccine, Recombinant > Protocol Summary for 104297

Protocol Summary for 104297

Protocol Summary
Protocol Id: 104297
Secondary Ids:
  • N/A
Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose.
Phase: phase 2
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CBER
IND/IDE Number: BB IND 10514
IND/IDE Serial Number: BB IND 10514
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • South Africa: Medicines Control Council
  • United States: Food and Drug Administration
Collaborators:
  • N/A
Brief Summary: This candidate 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 Plasmodium 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.
Detailed Description:
Record Verification Date: September 2011
Status: Completed
Why Study Stopped:
Study Start Date: April 2005
Study Completion Date: May 2007
Study Completion Date Type: Actual
Primary Completion Date: May 2007
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Open Label
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Occurrence of serious adverse events (SAEs) yes Over a period 21 to 45 months post Dose 1 of GSK 257049 vaccineor comparator vaccine
Secondary Outcomes:
  • Anti-circumsporozoite protein (CS) antibody titres. no Month 33 & Month 45
  • Anti-hepatitis B (HBs) antibody titres. no In groups C and D, Month 33 & Month 45
  • In groups A and B, first clinical episode of symptomatic P. falciparum malaria for Primary Case Definition for malaria episodes detected by passive case detection no Month 21 to 33/Month 33 to 45/Month 2½ to 33/Month 2½ to 45.
  • In groups A and B, first clinical episode of symptomatic P. falciparum malaria for Secondary Case Definitions 1 3 for malaria episodes detected by passive case detection no Month 21 to 33/Month 33 to 45/Month 2½ to 33/Month 2½ to 45.
  • In groups A and B, the total number of clinical episodes of symptomatic P. falciparum malaria (Primary Case Definition for malaria episodes). no From Month 21 to 33/Month 33 to 45/Month 2½ to 33/Month 2½ to 45
  • In groups A and B, presence of anaemia in children. no At Month 33 and Month 45
  • In groups A and B, the number of asexual stage falciparum parasites per µL of blood for each subject no At Month 33 and Month 45
Conditions:
  • Plasmodium falciparum
  • Malaria
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 33 Months
Maximum Age: 69 Months
Enrollment: 1737
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information