NCT00872963

Brief Summary

Malaria is one of the leading causes of deaths in children below five years old. Despite antimalarial drugs and insecticide treated bed nets, the established means of treatment and protection, malaria still continues to affect many children. A malaria vaccine would be a very effective way of reducing malaria infection in the community. RTS,S/AS01E is a leading malaria vaccine candidate which is being developed for children in Africa. The investigators have done a study to find out if this vaccine is effective in reducing infection by malaria in children aged 5-17 months living in Kenya and Tanzania. The follow up of the original study was 14-18 months. The extended follow up is proposed to continue for another four years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

7 years

First QC Date

March 31, 2009

Last Update Submit

December 4, 2015

Conditions

Malaria

Keywords

malaria vaccineRTS,S,

Outcome Measures

Primary Outcomes (1)

  • Long term febrile malaria episodes

    4 years

Secondary Outcomes (2)

  • To compare the age distribution of episodes of malaria following vaccination with RTS,S with the age distribution following control vaccination.

    4 years

  • To compare the in vitro markers of naturally acquired immunity in vaccinated and unvaccinated children, and assess the associations of these markers with subsequent episodes of febrile malaria.

    4 years

Study Arms (2)

RABIES VACCINE

Those subjects who received the active comparator

Biological: RTS,S/AS01E

RTS,S/AS01E

The subjects who received investigational product

Biological: RTS,S/AS01E

Interventions

RTS,S/AS01EBIOLOGICAL

0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule

Also known as: rabies vaccine BP, Sanofi-Pasteur
RABIES VACCINERTS,S/AS01E

Eligibility Criteria

Age19 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The local population is predominantly from Mijikenda ethnic group. The study area is within Kilifi District at the Kenyan coast and majority are subsistence farmers.Kilifi District experiences long rains in May-July and short rains in November/December. Measured Entomological Inoculation Rates in the area vary from 10-50 per year.

You may qualify if:

  • Enrollment and vaccination in the RTS,S/AS01E clinical trial (NCT00380393)
  • Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.

You may not qualify if:

  • Moving out of the study area, so that follow up is impractical.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kemri Wellcome Trust Research Programme

Kilifi, Coast Province, 80108, Kenya

Location

Related Publications (2)

  • Olotu A, Fegan G, Wambua J, Nyangweso G, Leach A, Lievens M, Kaslow DC, Njuguna P, Marsh K, Bejon P. Seven-Year Efficacy of RTS,S/AS01 Malaria Vaccine among Young African Children. N Engl J Med. 2016 Jun 30;374(26):2519-29. doi: 10.1056/NEJMoa1515257.

    PMID: 27355532DERIVED

  • Olotu A, Fegan G, Wambua J, Nyangweso G, Awuondo KO, Leach A, Lievens M, Leboulleux D, Njuguna P, Peshu N, Marsh K, Bejon P. Four-year efficacy of RTS,S/AS01E and its interaction with malaria exposure. N Engl J Med. 2013 Mar 21;368(12):1111-20. doi: 10.1056/NEJMoa1207564.

    PMID: 23514288DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Yearly cross sectional bleeds to collect blood samples.

MeSH Terms

Conditions

Malaria

Interventions

RTS malaria vaccine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Ally Olotu

    KEMRI-Wellcome Trust Collaborative Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

December 7, 2015

Record last verified: 2015-12

Locations

KE(1)