EUCTR2015-001538-25-Outside-EU/EEA
Active, not recruiting
Not 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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy volunteers (Primary immunization against Plasmodium falciparum malaria).
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 214
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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