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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201104000284208 Date registered: 2011/03/29
TRIAL DESCRIPTION
Public title Study to evaluate immunogenicity of the hepatitis B antigen of the GSK Biologicals¿ candidate malaria vaccine (257049)
Official scientific title Immunogenicity of the hepatitis B antigen of the GSK Biologicals¿ candidate malaria vaccine (257049)
Brief summary describing the background
and objectives of the trial
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
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Prevention
Anticipated trial start date 2011-04-30
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants) 705   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
113681 Protocol Number

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Central randomization system on internet, minimization procedure accounting for centre Central randomization system on internet Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Candidate malaria vaccine lot 3 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 3 + Infanrix/Hib, Polio Sabin and Synflorix. Rotarix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after third dose of primary vaccination 47
Experimental group Candidate malaria vaccine lot 1 & co-administred vaccines 3 doses 3 doses of candidate malaria vaccine lot 1 + Infanrix/Hib, Polio Sabin and Synflorix. Rotarix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after third dose of primary vaccination 47
Experimental group Candidate malaria vaccine lot 2 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 2 + Infanrix/Hib, Polio Sabin and Synflorix. Rotarix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after third dose of primary vaccination 47
Experimental group Candidate malaria vaccine lot 1 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 1 + Infanrix/Hib, Polio Sabin and Rotarix. Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after third dose of the primary vaccinati 47
Experimental group Candidate malaria vaccine lot 2 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 2 + Infanrix/Hib, Polio Sabin and Rotarix. Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after third dose of the primary vaccinati 47
Experimental group Candidate malaria vaccine lot 3 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 3 + Infanrix/Hib, Polio Sabin and Rotarix. Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after third dose of the primary vaccinati 47
Experimental group Candidate malaria vaccine lot 1 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 1 + Infanrix/Hib & Polio Sabin. Rotarix & Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after 3rd dose of primary vaccination 47
Experimental group Candidate malaria vaccine lot 2 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 2 + Infanrix/Hib & Polio Sabin. Rotarix & Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after 3rd dose of primary vaccination 47
Experimental group Candidate malaria vaccine lot 3 & co-administered vaccines 3 doses 3 doses of candidate malaria vaccine lot 3 + Infanrix/Hib & Polio Sabin. Rotarix & Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of candidate malaria vaccine, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and one dose of Engerix-B 48 months after 3rd dose of primary vaccination 47
Control group Engerix-B + co-administered vaccines 3 doses 3 doses of Engerix-B + Infanrix/Hib, Polio Sabin and Synflorix. Rotarix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of Engerix-B, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and an Engerix-B booster vaccination at 48 months after third dose of Engerix-B in primary vaccination 141 Active
Control group Engerix-B + co-administered vaccines 3 doses 3 doses of Engerix-B + Infanrix/Hib, Polio Sabin and Rotarix. Synflorix will be given in a staggered way. Subjects will also receive measles and yellow fever vaccines6 months post Dose 3 of Engerix-B, Synflorix and Infanrix/Hib booster vaccinations at approximately 18 months of age, and an Engerix-B booster vaccination at 48 months after third dose of Engerix-B in the primary vaccination 141 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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. 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. 8 Weeks 12 Weeks Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/01/19 Committee de Recherche en Science de la Santé
Ethics Committee Address
Street address City Postal code Country
01 BP 364 Ouagadougou 01 Burkina Faso

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Outcome 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
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome Lot-to lot consistency for immunogenicity of three lots of the candidate malaria vaccine 1 month post Dose 3 of the candidate malaria vaccine
Secondary Outcome Non-inferiority of the immune response to the acellular B pertussis antigens of the diphtheria, tetanus, pertussis (acellular) and Haemophillus 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
Secondary Outcome 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
Secondary Outcome Non-inferiority & 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
Secondary Outcome Non-inferiority & 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
Secondary Outcome 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
Secondary Outcome Immune response to a booster dose of a licensed hepatitis B vaccine 1 month post booster dose of Engerix-B
Secondary Outcome 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
Secondary Outcome Immune response against the protein D (PD) component of the pneumococcal antigen 1 month post Dose 3 of pneumococcal conjugate vaccine
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome 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
Secondary Outcome Occurrence of fatal SAEs From study start until study end (52 months)
Secondary Outcome Occurrence of immune mediated disorders (IMDs) From study start until study end (52 months)

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut de Rechererch en Science de la Sante 01 BP 364 Ougadougou Burkina Faso
Kumasi Center for Collaborative Research (KCCR) Kwane Nkrumah University of Sciene and Technology (KNUST) Kumasi Ghana

FUNDING SOURCES
Name of source Street address City Postal code Country
GlaxoSmithKline Biologicals Rue de l¿Institut 89 Rixensart 1330 Belgium

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor GlaxoSmithKline Biologicals Rue de l¿Institut 89, Rixensart 1300 Belgium Funding Agency

COLLABORATORS
Name Street address City Postal code Country
None

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Dr Clinical Disclosure Advisor GSKClinicalSupportHD@ gsk.com 001-877-379-3718
Street address City Postal code Country Position / Affiliation
Clinical Disclosure Advisor
Role Name Email Phone Fax
Public Enquiries Dr Clinical Disclosure Advisor GSKClinicalSupportHD@ gsk.com 001-877-379-3718
Street address City Postal code Country Position / Affiliation
Clinical Disclosure Advisor
Role Name Email Phone Fax
Principal Investigator Dr Clinical Disclosure Advisor GSKClinicalSupportHD@ gsk.com 001-877-379-3718
Street address City Postal code Country Position / Affiliation
Clinical Disclosure Advisor