GSK: Protocol Summary for 103967

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Protocol Summary for 103967

Protocol Summary
Protocol Id:	103967
Secondary Ids:	N/A
Title:	A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region
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:	NA
Has Expanded Access?:	no
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:	N/A
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 0.5 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 I/IIb 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 (0.5 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 = 1/2 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.
Record Verification Date:	July 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	August 2005
Study Completion Date:	December 2007
Study Completion Date Type:	Actual
Primary Completion Date:	December 2007
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	no
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Number of Subjects Reporting Serious Adverse Events (SAEs) no From the time of first TETRActHib vaccination until month 6 post Dose 1
Secondary Outcomes:	Number of Subjects Reporting Unsolicited Adverse Events (AEs) Following GSK 257049 or Engerix-B Vaccination no over a 14-day follow-up period after Doses 1 and 2 of GSK 257049 vaccine or Engerix-B; and over a 30-day follow-up period after Dose 3 of GSK 257049 vaccine or Engerix-B Number of Subjects Reporting Solicited General and Local Reactions Following TETRActHib Vaccination no over a 7-day follow-up period (day of vaccination and 6 subsequent days) after TETRActHib Number of Subjects Reporting Solicited General and Local Reactions Following GSK 257049 or Engerix-B Vaccination no over a 7-day follow-up period (day of vaccination and 6 subsequent days) after GSK 257049 vaccine or Engerix-B Anti-HBs antibody titers; difference between groups in percent seroprotection no one month post Dose 3 of GSK 257049 vaccine or Engerix-B Anti-hepatitis B (anti-HBs) antibody titers no prior to vaccination, 1 month post Dose 3 of Engerix B Anti-circumsporozoite protein (anti-CS) antibody titers no prior to vaccination, 1 month post Dose 3, 3½ months post Dose 3 of GSK 257049 vaccine or Engerix B Anti-diphtheria antibody titers no 1 month post Dose 3 of TETRActHib Anti-tetanus antibody titers no 1 month post Dose 3 of TETRActHib Anti-pertussis antibody titers no 1 month post Dose 3 of TETRActHib Number of Subjects Reporting Unsolicited Adverse Events (AEs) Following TETRActHib Vaccination no over a 14-day follow-up period after Doses 1, 2 and 3 of TETRActHib Anti-polyribosyl ribitol phosphate (anti-PRP) antibody titers no 1 month post Dose 3 of TETRActHib first P. falciparum malaria infection no Starting 14 days after last vaccination with extending for 12 weeks. Asexual P. falciparum parasitemia no At 3½ months post Dose 3
Conditions:	Plasmodium falciparum Malaria
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: •A male or female infant of between 6 and 12 weeks of age at the time of first vaccination. •Written informed consent obtained from the parent(s) or guardian(s) of the subject •Free of obvious health problems as established by medical history and clinical examination before entering into the study. •Born to a mother who is hepatitis B surface antigen (HBsAg) negative and human immunodeficiency virus (HIV) negative. •Born after a normal gestation period (between 36 and 42 weeks). •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. Exclusion Criteria: •Bacillus Calmette-Guérin tuberculosis vaccine (BCG) administration within one week of proposed administration of a study vaccine. •Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth •Any chronic drug therapy to be continued during the study period. •Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b or hepatitis B vaccines. •Major congenital abnormality. •Serious acute or chronic illness determined by clinical, physical examination and laboratory screening tests •Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination •A family history of congenital or hereditary immunodeficiency. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. •History of any neurological disorders or seizures. •Maternal death. •Hemoglobin < 80 g/L •Simultaneous participation in any other clinical trial. •Same sex twin •Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trialModerate malnutrition at screening
Gender:	Both
Minimum Age:	6 Weeks
Maximum Age:	12 Weeks
Enrollment:	214
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 Mozambique (click to view all sites in Mozambique) GSK Investigational Site Mozambique, , ; Completed;

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Protocol Summary for 103967