Study to evaluate immunogenicity of the hepatitis B antigen of the GSK Biologicals? candidate malaria vaccine (257049)

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201104000284208
• Date of registration: 29/03/2011
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Study to evaluate immunogenicity of the hepatitis B antigen of the GSK Biologicals? candidate malaria vaccine (257049)
• Scientific title: Immunogenicity of the hepatitis B antigen of the GSK Biologicals? candidate malaria vaccine (257049)
• Date of first enrolment: 2011-04-30
• Target sample size: 705
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201104000284208
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: Clinical Disclosure Advisor

• Name: Clinical Disclosure Advisor
• Affiliation: Clinical Disclosure Advisor

Key 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.


Age minimum: 8 Week
Age maximum: 12 Week
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Hepatitis B

Primary Outcome(s)

Non-inferiority of the immune response to the hepatitis B antigen induced by the candidate malaria vaccine versus a licensed hepatitis B vaccine

Secondary Outcome(s)

Immune response (on a long-term) to the CS-antigen after a primary course of the candidate malaria 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

Immune response against the protein D (PD) component of the pneumococcal antigen

Immune response to a booster dose of a licensed hepatitis B vaccine

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

Immune response to hepatitis B antigen of the candidate malaria vaccine or a licensed hepatitis B vaccine

Immune response to the acellular B pertussis antigens of the DTPa/Hib vaccine when given with the candidate malaria vaccine

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

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

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

Lot-to lot consistency for immunogenicity of three lots of the candidate malaria vaccine

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

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

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

Occurrence of fatal SAEs

Occurrence of immune mediated disorders (IMDs)

Occurrence of SAEs

Occurrence of serious adverse events (SAEs)

Occurrence of solicited general and local adverse events (AEs) after vaccination with the candidate malaria vaccine or a licensed hepatitis B vaccine

Occurrence of unsolicited AEs after vaccination with the candidate malaria vaccine or a licensed hepatitis B vaccine

Secondary ID(s)

113681

Source(s) of Monetary Support

GlaxoSmithKline Biologicals