Efficacy of GSK Biologicals’ candidate malaria vaccine RTS,S/AS01E against malaria disease in infants and children in Africa.

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

• Registration Number: EUCTR2012-005716-26-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-17
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 15458

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
-A male or female child of 5-17 months (inclusive) of age at time of first vaccination, or between 6-12 weeks (inclusive) of age at time of first vaccination and NOT have already received a dose of vaccine against diphtheria, tetanus or pertussis or Hemophilus influenzae type B and must be > 28 days of age at screening.
-Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
-Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
All subjects must satisfy the following criteria at the start of the extension phase:
-Subjects who were enrolled and who received at least one vaccine dose in the primary trial phase.
-Subjects who were present for Visit 35 on or before 30 Sep-tember 2013.
-Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15458
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 apply, the subject must not be included in the study:
-Acute disease at the time of enrolment (acute disease is de-fined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5°C).
-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
-Anemia defined as: hemoglobin < 5.0 g/dL or hemoglobin < 8 g/dL associated with clinical signs of heart failure or severe respiratory distress.
-Major congenital defects.
-History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations.
-Children with a past history of a neurological disorder or atypical febrile seizure (a febrile seizure is atypical if it meets one of the following criteria: not associated with fever; lasts > 5 minutes; focal (not generalized); followed by transient or persistent neurological abnormality; occurs in a child < 6 months of age).
Children with malnutrition requiring hospital admission.
Children currently meeting the criteria for HIV disease of Stage III or Stage IV severity as defined by the World Health Organi-zation [WHO, 2005]. NB: a previous history of having Stage III or Stage IV HIV disease is NOT an exclusion criterion.
-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to a drug or vaccine that is not licensed for that indication (by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) with the exception of studies with the objective of improving the drug treatment or clinical management of severe malaria disease.
-Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-Previous participation in any other malaria vaccine trial.
-Receipt of a vaccine within the preceding 7 days
-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.

Study & Design

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