Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201408000873384 Date of Approval: 25/08/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An extension to study MALARIA-055 PRI to evaluate the long-term efficacy, safety and immunogenicity of GSK Biologicals malaria vaccine in Africa.
Official scientific title Extension to study MALARIA-055 PRI (NCT00866619) for evaluation of long-term efficacy, safety and immunogenicity of GSK Biologicals candidate malaria vaccine (SB257049) in infants and children in Africa.
Brief summary describing the background and objectives of the trial The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals' RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/09/2014
Actual trial start date
Anticipated date of last follow up 31/01/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 4000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
200599 Protocol Number
NCT02207816 ClinicalTrials.gov Identifier
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Central randomisation system on Internet Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Central randomisation system on Internet Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group R3R Group 3 Infants/children assigned to the R3R group received 3 doses of RTS,S/AS01E on a 0-, 1-, 2-month schedule, and a booster dose of RTS,S/AS01E at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). 1200
Control Group R3C Group 3 Infants/children assigned to the R3C group received 3 doses of RTS,S/AS01E on 0-, 1-, 2-month schedule, and a dose of comparator vaccine at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). 1200 Active-Treatment of Control Group
Control Group C3C Group 3 Infants/children assigned to the C3C group received 3 doses of a comparator vaccine on 0-, 1-, 2-month schedule, and a dose of comparator vaccine at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). 1200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Subjects parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619. - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - Child in care. - Use of any investigational or non-registered product or planned use during the study period. 42 Month(s) 9 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/06/2014 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
P.O. Box 9653 Dar es Salaam 9653 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/07/2014 Ministere De La Sante
Ethics Committee Address
Street address City Postal code Country
Comite D'Ethique Institutionnel du Centre Muraz, BP 390 Bobo-Dioulasso 390 Burkina Faso
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2014 Kenya Medical Research Institute (KEMRI)
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road, P.O. Box 54840-00200 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of severe malaria meeting the primary case definition. Starting January 2014 until the end of the 3-year follow-up period (Year 3).
Secondary Outcome Occurrence of clinical malaria meeting the primary and secondary case definitions Starting January 2014 until the end of the 3-year follow-up period (Year 3).
Secondary Outcome Occurrence of malaria hospitalization meeting each of the case definitions Starting January 2014 until the end of the 3-year follow-up period (Year 3).
Secondary Outcome Prevalence of parasitemia, in both age categories (6-12 weeks and 5-17 months). At three annual timepoints (Year 1, 2 and 3).
Secondary Outcome Prevalence of anemia, in both age categories (6-12 weeks and 5-17 months). At three annual timepoints (Year 1, 2 and 3).
Secondary Outcome Level of hemoglobin, in both age categories (6-12 weeks and 5-17 months). At three annual timepoints (Year 1, 2 and 3).
Secondary Outcome Occurrence of severe malaria meeting the primary and secondary case definitions, in both age categories (6-12 weeks and 5-17 months). Starting at the beginning of the primary study (MALARIA-055 PRI NCT00866619; Visit 2) until the end of the follow-up period (Year 3).
Secondary Outcome Occurrence of clinical malaria meeting the primary and secondary case definitions, in both age categories (6-12 weeks and 5-17 months). Starting at the beginning of the primary study (MALARIA-055 PRI NCT00866619; Visit 2) until the end of the follow-up period (Year 3).
Secondary Outcome Occurrence of malaria hospitalization meeting all case definitions, in both age categories (6-12 weeks and 5-17 months). Starting at the beginning of the primary study (MALARIA-055 PRI NCT00866619; Visit 2) until the end of the follow-up period (Year 3).
Secondary Outcome Occurrence of the following reported serious adverse events (SAEs): fatalities, related SAEs (related to vaccine administration in the primary study MALARIA-055 PRI NCT00866619 and to study participation), malaria hospitalization, pIMDs, and meningitis. Starting January 2014 until the end of the 3-year follow-up period (Year 3).
Secondary Outcome Annual anti- circumsporozoite antibody titers for children of both age categories (6-12 weeks and 5-17 months). At three annual time points (Year 1, 2 and 3).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
USA Medical Research Unit Kenya Medical Research Institute, Jomo Kenyatta Highway, P.O. Box 54 Kisumu 40100 Kenya
Institut de Recherche en Sciences de la Santé (IRSS-DRO) 01 BP 545 Bobo Dioulasso 01 Burkina Faso
National Institute for Medical Research (NIMR) within Joint Malaria Programme Korogwe District Hospital - Magunga, P.O Box 210, Korogwe Tanga Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
GlaxoSmithKline Rue de l'Institut 89 Rixensart 1330 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor GlaxoSmithKline Biologicals Rue de l'Institut 89 Rixensart 1330 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Not Applicable
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clinical Disclosure Advisor Call Center GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
Role Name Email Phone Street address
Public Enquiries Clinical Disclosure Advisor Call Center GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
Role Name Email Phone Street address
Scientific Enquiries Clinical Disclosure Advisor Call Center GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
REPORTING
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Result URL Hyperlinks
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