GSK: Protocol Summary for 104298

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Protocol Summary for 104298

Protocol Summary
Protocol Id:	104298
Secondary Ids:	N/A
Title:	Safety, immunogenicity & proof-of-concept study of GSK 257146, a candidate malaria vaccine, when incorporated into an Expanded Program on Immunization (EPI) regimen that includes DTPw/Hib 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 United States: Food and Drug Administration
Collaborators:	N/A
Brief Summary:	GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 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). In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description:	This is a phase 2b trial designed to evaluate the safety and immunogenicity of RTS,S/AS02D when co-administered with a multivalent DTPw/Hib (Aventis Pasteur’s TETRActHib vaccine). Infants randomized to the control group will receive a licensed hepatitis B vaccine, Engerix-B in place of RTS,S/AS02D. Data pertaining to RTS,S/AS02D or Engerix-B will be collected in a double blinded manner; data relating to TETRActHib will be collected in an open fashion. Oral polio vaccine (OPV) will be administered at birth, 8, 12, 16 weeks in co-administration with other vaccines and will not be administered as part of this protocol. Antibody titers to OPV will not be assessed as part of this protocol.
Record Verification Date:	April 2009
Status:	Completed
Why Study Stopped:
Study Start Date:	September 2006
Study Completion Date:	January 2009
Study Completion Date Type:	Actual
Primary Completion Date:	January 2009
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:	Occurrence of SAEs yes From the time of first vaccination until seven months post Dose 3 (Month 9). Anti-Hepatitis B surface agent (HBs) antibody titers: difference between groups in percent seroprotection. no One month post Dose 3 Anti-diphtheria antibody titers: difference between groups in percent seroprotection no One month post Dose 3. Anti-tetanus antibody titers: difference between groups in percent seroprotection no One month post Dose 3. Anti- polyribosyl-ribitol-phosphate (anti-PRP) antibody titers: difference between groups in percent seroprotection. no One month post Dose 3. Anti-pertussis antibody titers: GMT ratio between groups no One month post Dose 3.
Secondary Outcomes:	Occurrence of unsolicited AEs. yes After Dose 1, 2 and 3 of vaccine over a 30-day follow-up period Occurrence of solicited general and local reactions. yes Over a 7-day follow-up period after each vaccination Anti HBs antibody titers. no Prior to vaccination, one month post Dose 2 and one month post Dose 3 Anti-tetanus antibody titers measured by ELISA no At screening and one month post Dose 3. Anti-pertussis antibody titers measured by ELISA no At screening and one month post Dose 3. Anti-PRP antibody titers measured by ELISA. no At screening and one month post Dose 3. First malaria infection (first recording of infection of asexual stage falciparum parasites detected by the active detection of infection surveillance). no Over a period starting 14 days after Dose 3 and extending for 6 months The asexual P. falciparum parasitemia (prevalence and density). no At 7 months post Dose 3 (Month 9). Antibody titers to the P. falciparum circumsporozoite (CS) repeat no Prior to vaccination, one month post Dose 2, one month post Dose 3 and 7 months post Dose 3 Anti-diphtheria antibody titers measured by ELISA. no At screening and one month post Dose 3.
Conditions:	Plasmodium falciparum Malaria
Keywords:	Malaria Coccidiosis Malaria, Falciparum Parasitic Diseases
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: •A male or female infant between 6 and 10 weeks of age at the time of first vaccination. •Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child. •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits). •Born to a mother who is HBsAg negative & HIV negative. •Born after a normal gestation period (between 36 and 42 weeks). •Subjects who live within a 5 km radius of a dispensary. Exclusion criteria: •Acute disease at the time of enrolment. •Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. •Laboratory screening tests out of range for haemoglobin, total white cell count, platelets, ALT and creatinine. •Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines. •BCG administration within one week of proposed administration of a study vaccine. •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). •Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. •Previous participation in any other malaria vaccine trial. •Simultaneous participation in any other clinical trial. •Same sex twin. •Maternal death. •History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. •Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Gender:	Both
Minimum Age:	6 Weeks
Maximum Age:	10 Weeks
Enrollment:	340
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 Tanzania (click to view all sites in Tanzania) GSK Investigational Site Dar-es-Salaam, , ; Completed;

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Protocol Summary for 104298