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Protocol Summary for 113681

Protocol Summary
Protocol Id:	113681
Secondary Ids:
Title:	Immunogenicity of the hepatitis B antigen of the GSK Biologicals’ candidate malaria vaccine (257049)
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Ghana: Food and Drugs Board (FDB) Burkina Faso: Ministère de la Santé du Burkina Faso
Collaborators:
Brief Summary:	This study has been designed to support the indication of the candidate vaccine against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.
Detailed Description:
Record Verification Date:	October 2012
Status:	Active not recruiting
Why Study Stopped:
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2016
Study Completion Date Type:	Anticipated
Estimated Primary Completion Date:	December 2016
Primary Completion Date Type:	Anticipated
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Non-inferiority of the immune response to the hepatitis B antigen induced by the candidate malaria vaccine versus a licensed hepatitis B vaccine 1 month post Dose 3 of the candidate malaria vaccine or Engerix-B
Secondary Outcomes:	Immune response to the circumsporozoite protein (CS) antigen of the candidate malaria vaccine when given as part of an EPI regimen with and without pneumococcal conjugate vaccine co-administration 1 month post Dose 3 of the candidate malaria vaccine Immune response to the 10 pneumococcal serotype antigens of the pneumococcal conjugate vaccine, when given as part of an EPI regimen with and without the candidate malaria vaccine co-administration 1 month post Dose 3 of pneumococcal conjugate vaccine Immune response against the protein D (PD) component of the pneumococcal antigen 1 month post Dose 3 of pneumococcal conjugate vaccine Immune response to the acellular B pertussis antigens of the DTPa/Hib vaccine when given with the candidate malaria vaccine At screening and 1 month post Dose 3 of the DTPa/Hib vaccine Immune response to hepatitis B antigen of the candidate malaria vaccine or a licensed hepatitis B vaccine 1 month post Dose 3 of the candidate malaria vaccine or Engerix-B Immune response to the rotavirus antigen of the rotavirus vaccine, when given as part of an EPI regimen with and without the candidate malaria vaccine co-administration 1 month post Dose 2 of rotavirus vaccine Lot-to lot consistency for immunogenicity of three lots of the candidate malaria vaccine 1 month post Dose 3 of the candidate malaria vaccine Immune response to a booster dose of a licensed hepatitis B vaccine 1 month post booster dose of Engerix-B Non-inferiority of the immune response to the acellular B pertussis antigens of the diphtheria, tetanus, pertussis (acellular) and Haemophilus influenza type b (DTPa/Hib) vaccine when given with and without the candidate malaria vaccine co-administration At screening and 1 month post Dose 3 of the DTPa/Hib vaccine Occurrence of solicited general and local adverse events (AEs) after vaccination with the candidate malaria vaccine or a licensed hepatitis B vaccine During the 7-day follow-up period after the first, second and third doses of the candidate malaria vaccine or a licensed hepatitis B vaccine Immune response (on a long-term) to the CS-antigen after a primary course of the candidate malaria vaccine At 12, 24, 36 and 48 months post Dose 3 of the candidate malaria vaccine Occurrence of fatal SAEs From study start until study end (52 months) Non-inferiority of the immune response to the 10 pneumococcal serotype antigens when pneumococcal conjugate vaccine is given as part of an EPI regimen with and without the candidate malaria vaccine co-administration 1 month post Dose 3 of pneumococcal conjugate vaccine Occurrence of unsolicited AEs after vaccination with the candidate malaria vaccine or a licensed hepatitis B vaccine Over a 30-day follow-up period after the first, second and third doses of the candidate malaria vaccine or a licensed hepatitis B vaccine Occurrence of serious adverse events (SAEs) From the time of first vaccination until 3 month post Dose 1 of the candidate malaria vaccine or a licensed hepatitis B vaccine Occurrence of immune mediated disorders (IMDs) From study start until study end (52 months) Immune response to a booster dose of pneumococcal conjugate vaccine when primary vaccination is given as part of an EPI regimen with and without the candidate malaria vaccine co-administration 1 month post booster dose of pneumococcal conjugate vaccine Occurrence of SAEs From the time of first vaccination until 8 month post Dose 1 of the candidate malaria vaccine or a licensed hepatitis B vaccine Immune response to the CS antigen of the candidate malaria vaccine when given as part of an EPI regimen with and without rotavirus co-administration 1 month post Dose 3 of the candidate malaria vaccine Non-inferiority of the immune response to the rotavirus antigen when the rotavirus vaccine is given as part of an EPI regimen with and without the candidate malaria vaccine co-administration 1 month post Dose 2 of rotavirus vaccine Immune response (on a long-term) to the hepatitis B antigen after a primary course of the candidate malaria vaccine or a licensed hepatitis B vaccine At 12, 24, 36 and 48 months post Dose 3 of the candidate malaria vaccine or Engerix-B
Conditions:	Plasmodium falciparum malaria Hepatitis B
Keywords:	Africa Plasmodium falciparum Malaria vaccine hepatitis B EPI
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: • A male or female infant aged between 8 and 12 weeks inclusive at the time of first vaccination • Signed or thumb-printed informed consent obtained from the parent(s)/Legally Acceptable Representative [LAR(s)] of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness • Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol • Healthy subjects 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 • Born to a mother who is Human Immunodeficiency Virus (HIV) negative • Born after a normal gestation period of 36 to 42 weeks inclusive. Exclusion Criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: • Child in care • Acute disease and/or fever 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 • Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b, Streptococcus pneumoniae, hepatitis B vaccine or rotavirus vaccines. • Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine. • Use of a drug or vaccine that is not approved for that indication 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 in the period between birth and Dose 1 and within the three months preceding planned vaccine administration during the study period. • Chronic administration of immunosuppressants or other immune-modifying drugs in the period between birth and Dose 1. • Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. • Same sex twin • Maternal death • History of allergic reactions 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. • Any other findings that the investigator feels would result in data collected being incomplete or of poor quality. • Previous participation in any other malaria vaccine trial.
Gender:	Both
Minimum Age:	8 Weeks
Maximum Age:	12 Weeks
Enrollment:	705
Enrollment Type:	Anticipated
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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 Burkina Faso (click to view all sites in Burkina Faso) GSK Investigational Site Ouagadougou 01, ; RECRUITING; Contact: Innocent Valea, Principal Investigator, . Ghana (click to view all sites in Ghana) GSK Investigational Site Kumasi, ; RECRUITING; Contact: Tsiri Agbenyega, Principal Investigator, .

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Protocol Summary for 113681