Last updated: 11/07/2018 13:30:17
A study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline (GSK) Biologicals’ candidate malaria vaccine RTS,S/AS02A, when administered to children aged 1 to 4 years living in a malaria-endemic region of Mozambique.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ candidate malaria vaccine RTS,S/AS02A, administered intramuscularly according to a 0, 1 and 2 month vaccination schedule in toddlers and children aged 1 to 4 years in a malaria-endemic region of Mozambique.
Trial description: Malaria is an important cause of death and serious illness among Mozambican children. Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be helpful if children could be protected against malaria by a vaccine. GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum and also would provide protection against infection with hepatitis B virus. Previous studies have shown the candidate malaria vaccine RTS,S/AS02 to be safe when administered in adults and children aged 1-11 years. However, to assess if this vaccine could provide protection against malaria in children, this study has been undertaken.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
2022
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Alonso PL et al. (2004) Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet. 364 (9443): 1411-1420.
Alonso PL et al. (2005) Duration of protection of the RTS,S/AS02A malaria vaccine in the prevention of Plasmodium falciparum disease in Mozambican children. Lancet. 366 (9502):2012-2018.
Enosse S et al. (2006) RTS,S/AS02A malaria vaccine does not induce parasite CSP T cell epitope selection and reduces multiplicity of infection. PLoS Clin Trials. 1(1): e5.
Guinovart C et al. (2009) Insights into long-lasting protection induced by RTS,S/AS02A malaria vaccine: further results from a phase IIb trial in Mozambican children. PLoS ONE. 4(4): e5165.
Sacarlal J et al. (2008) Safety of the RTS,S/AS02A malaria vaccine in Mozambican children during a Phase IIb trial. Vaccine. 26 (2):174-184.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
July 2003 to April 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
1 - 4 years
Accepts healthy volunteers
Yes
- Healthy male and female children, 1 to 4 years of age at the time of first vaccination (up to but not including 5th birthday).
- Written/thumbprinted and witnessed informed consent obtained from the parents or legal guardians.
- Major congenital defects or serious chronic illness.
- History of allergic reactions to vaccination or to any component of the Hiberix™, Prevnar® or Engerix-B™ vaccines.
Inclusion and exclusion criteria
Inclusion criteria:
- Written/thumbprinted and witnessed informed consent obtained from the parents or legal guardians.
Healthy male and female children, 1 to 4 years of age at the time of first vaccination (up to but not including 5th birthday).
Exclusion criteria:
- History of allergic reactions to vaccination or to any component of the Hiberix™, Prevnar® or Engerix-B™ vaccines.
- Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune modifying drugs within six months prior to the first vaccine dose .
- Previous vaccination with an experimental vaccine or with hepatitis B vaccine in children equal to or more than 18 months of age.
- Simultaneous participation in any other clinical trial.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Major congenital defects or serious chronic illness.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-29-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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