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 Identifier: NCT00197041|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Biological: RTS,S/AS02A||Phase 2|
In this study, the participating children will either receive either 3 doses of the new malaria vaccine or the control vaccine which has been selected because of its benefit to the children in preventing important childhood diseases. The control vaccines include the following:
- If the child is of 24 months or older, he/she may receive 3 doses of a vaccine, called Engerix-B™, which protects against hepatitis B.
- If the child is less than 24 months, he/she may receive: two doses of a vaccine called Prevnar® and one dose of a vaccine called Hiberix™. Prevnar® prevents pneumonia and meningitis caused by some Streptococcus pneumoniae bacteria. Hiberix™ prevents severe infections such as pneumonia and meningitis caused by Haemophilus influenzae type b bacteria (Hib). All children will be monitored for the development of malaria disease over an 18-month period extending from the third vaccination. All participants will also be monitored for vaccine safety from first vaccination to study close.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2022 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2005|
- Time to the first clinical episode of symptomatic Plasmodium falciparum malaria infection detected over the 6-month surveillance period after Dose 3 vaccination.
- Occurrence of episodes of asymptomatic and symptomatic infections of Plasmodium falciparum malaria. Occurrence of solicited symptoms, unsolicited symptoms and SAEs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197041
|GSK Investigational Site|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|