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

• Conditions: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria, immunization against hepatitis B); Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2011-001508-37-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 705

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 705
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified