EUCTR2015-001538-25-Outside-EU/EEAActive, not recruitingNot Applicable
A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region - MALARIA-038
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 214
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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