Examine safety & immune responses of GSK 257049 vaccine when administered to infants living in a malaria-endemic regio

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

• Registration Number: EUCTR2015-001538-25-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

•A male or female infant of between 6 and 12 weeks of age at the time of first vaccination.
•Written informed consent obtained from the parent(s) or guardian(s) of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Born to a mother who is HBsAg negative.
•Born to a mother who is HIV negative.
•Born after a normal gestation period (between 36 and 42 weeks).
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 214
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

•BCG administration within one week of proposed administration of a study vaccine.
•Use of any investigational or non-registered drug or vaccine 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 since birth or planned administration during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
•Any chronic drug therapy to be continued during the study period.
•Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Haemophilus influenzae type b or hepatitis B vaccines.
•Major congenital abnormality.
•Serious acute or chronic illness determined by clinical, physical examination and laboratory screening tests.
•Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•History of any neurological disorders or seizures.
•Maternal death.
•Moderate malnutrition at screening defined as weight for age Z-score less than -2; this corresponds to a weight of equal or less than 3.9 kg for 2 month old boys and equal or less than 3.6 kg for 2 month old girls.
•Hemoglobin < 80 g/L.
•Simultaneous participation in any other clinical trial.
•Same sex twin.
•Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Study & Design

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