Status:
COMPLETED
Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
The PATH Malaria Vaccine Initiative (MVI)
Conditions:
Malaria
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
Detailed Description
The protocol posting document has been updated due to a protocol amendment dated 23 January 2012. An analysis time point has been added at Month 20. No changes have been made to the protocol endpoints...
Eligibility Criteria
Inclusion
- 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 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.
- 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 September 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.
Exclusion
- 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 enrollment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- Anemia associated with clinical signs or symptoms of decompensation or hemoglobin ≥ 5.0 g/dL.
- 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.
- 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 Organization.
- 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 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 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
Key Trial Info
Start Date :
March 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2014
Estimated Enrollment :
15459 Patients enrolled
Trial Details
Trial ID
NCT00866619
Start Date
March 27 2009
End Date
January 31 2014
Last Update
October 9 2019
Active Locations (10)
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1
GSK Investigational Site
Ouagadougou, Burkina Faso
2
GSK Investigational Site
Lambaréné, Gabon
3
GSK Investigational Site
Kintampo, Ghana
4
GSK Investigational Site
Kumasi, Ghana