Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197041
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-09-13
Brief Title:
A Study to Evaluate the Safety Immunogenicity and Efficacy of GlaxoSmithKline GSK Biologicals Candidate Malaria Vaccine RTSSAS02A When Administered to Children Aged 1 to 4 Years Living in a Malaria-endemic Region of Mozambique
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Study to Evaluate the Safety Immunogenicity and Efficacy of GlaxoSmithKline Biologicals Candidate Malaria Vaccine RTSSAS02A 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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 RTSSAS02 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 RTSSAS02 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
GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTSSAS02 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 RTSSAS02 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
Detailed Description:
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 heshe may receive 3 doses of a vaccine called Engerix-B which protects against hepatitis B
If the child is less than 24 months heshe 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
If the child is of 24 months or older heshe may receive 3 doses of a vaccine called Engerix-B which protects against hepatitis B
If the child is less than 24 months heshe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None