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.: PACTR201602001483150 Date of Approval: 23/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Immunogenicity & safety of GSK Biologicals malaria vaccine given at 6,7.5 &9 months of age coadministered with measles,rubella & yellow fever vaccines
Official scientific title Immunogenicity and safety study of GSK Biologicals¿ candidate malaria vaccine (SB257049) given at 6, 7.5 and 9 months of age in co-administration with measles, rubella and yellow fever vaccines followed by a booster of the malaria vaccine
Brief summary describing the background and objectives of the trial The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the RTS,S/AS01E candidate malaria vaccine when co-administered with Vitamin A, measle, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/09/2016
Actual trial start date
Anticipated date of last follow up 21/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
200596 Protocol Number
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 Simple randomisation using a radomisation table created by a computer software program Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Vitamin A 1 Dose Oral administration of Vitamin A (1 dose) 58 Active-Treatment of Control Group
Control Group Candidate Plasmodium falciparum malaria vaccine 4 Doses Intramuscular administration of RTS,S/AS01E vaccine (4 doses) 58 Active-Treatment of Control Group
Experimental Group MR-Vac 1 Dose Subcutaneous injection of a combined measles and rubella vaccine (1 dose each) in RTS,S group and Co-ad group) 117
Control Group MR-Vac 1 Dose Subcutaneous injection of a combined measles and rubella vaccine (1 dose) 58 Active-Treatment of Control Group
Control Group Stamaril 1 Dose Intramuscular injection of a yellow fever vaccine (1 dose) 58 Active-Treatment of Control Group
Experimental Group Vitamin A 1 Dose Oral administration of Vitamin A (1 dose each) in RTS,S group and Co-ad group 117
Experimental Group Stamaril 1 Dose Intramuscular injection of a yellow fever vaccine (1 dose each) in RTS,S group and Co-ad group) 117
Experimental Group Candidate Plasmodium falciparum malaria vaccine 4 Doses Intramuscular administration of RTS,S/AS01E vaccine (4 doses each) in RTS,S group and Co-ad group 117
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Subjects¿ parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. ¿A male or female 6 months of age (from the day the child becomes 6 months of age until the day before the child achieves 7 months of age) at the time of the first vaccination. ¿Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness. ¿Healthy subjects as established by medical history and clinical examination before entering into the study. ¿Previously received three documented doses of diphtheria, tetanus, and whole-cell pertussis, hepatitis B vaccine (DTPwHepB), and a 3-dose course of oral polio vaccine and, if locally recommended, pneumococcal and rotavirus vaccines. ¿Child in care ¿Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the 1st dose of study vaccine, or planned use during the study period. ¿Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. ¿Chronic administration of immunosuppressants or other immunemodifying drugs within 6 months prior to the 1st vaccine dose. For corticosteroids, this will mean prednisone ¿0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. ¿Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 7 days before the 1st dose of RTS,S/AS01E/measles, rubella and YF vaccines and ending 42 days after last dose of vaccines given at 9 months of age, with the exception of oral polio vaccine which could be given for unforseen public health threat. ¿Concurrently participating in another clinical study, at any time during the study period, in which subject has been or will be exposed to an investigational or a noninvestigational vaccine/product. ¿Previous vaccination against measles, YF or rubella. ¿Previous administration of Vitamin A. ¿Moderate or severe malnutrition at screening defined as weight for age Z-score <-2. ¿Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. ¿Family history of congenital or hereditary immunodeficiency. ¿History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). ¿Major congenital defects or serious chronic illness. ¿History of any neurological disorders or seizures. ¿Acute disease and/or fever at the time of enrolment. ¿Administration of immunoglobulins and/or any blood products within the 3 months preceding the 1st dose of study vaccine or planned administration during the study period ¿Same sex twin ¿Maternal death ¿Previous participation in any other malaria study 6 Month(s) 6 Month(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 17/11/2015 Kintampo Health Research Centre
Ethics Committee Address
Street address City Postal code Country
P.O.Box 200 Kintampo Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anti-CS antibody titers At one month post vaccination (Month 4)
Secondary Outcome Anti-CS and anti-HBs antibody titers and seropositivity At Screening (Day 0) and one month post-vaccination (Month 4)
Secondary Outcome Seroconversion for anti-Measles antibodies At one month post-vaccination (Month 4)
Secondary Outcome Anti-Measles antibody titers and seropositivity At pre-vaccination (Month 3) and one month post-vaccination (Month 4)
Secondary Outcome Seroconversion for anti-Rubella antibodies At one month post-vaccination (Month 4)
Secondary Outcome Anti-Rubella antibody titers and seropositivity At pre-vaccination (Month 3) and one month post-vaccination (Month 4)
Secondary Outcome Anti-YF antibody titers and seropositivity At one month post-vaccination with the YF vaccine (Month 4)
Secondary Outcome Solicited local and general AEs During the 7-day period (day 0-6) after Visit 2 (6 months of age) and after Visit 3 (7.5 months of age) and the 14-day period (day 0-13) after Visit 4 (9 months of age)
Secondary Outcome Unsolicited adverse events (AEs) During the 30-day period (day 0-29) after Visits 2 and 3 (at 6 and 7.5 month of age), the 42-day period (day 0-41) after Visit 4 (9 months of age)
Secondary Outcome Unsolicited adverse events (AEs) For Coad and RTS,S groups during the 30-day period (day 0-29) after Visit 10 (27 months of age), and for Control group, during the 30-day period (day 0-29) after Visits 6, 7, 8 and 12 (at 10.5, 11.5, 12.5 and 30 months of age10.5, 11.5, 12.5 and 30 months of age)
Secondary Outcome Occurrence of any, fatal and related serious adverse events (SAEs) From Screening visit (Day 0) until Month 4.5 and until study end (Month 33 for Coad and RTS,S groups and Month 36 for the Control group)
Secondary Outcome Occurrence of any, fatal and related SAEs Within 30 days (day 0-29) after each administrations
Secondary Outcome Occurrence of pIMDs From Day 0 until Month 4.5 and until study end (Month 33 for Coad and RTS,S groups and Month 36 for the Control group)
Secondary Outcome Occurrence of meningitis From Day 0 until Month 4.5 and until study end (Month 33 for Coad and RTS,S groups and Month 36 for the Control group)
Secondary Outcome Occurrence of seizure Within 30 days post-vaccination for vaccine doses administered at 6 and 7.5 months of age [Visits 2 and 3] or 42 days post-vaccination for vaccine doses administered at 9 months of age [Visit 4]) from Day 0 until Month 4.5.
Secondary Outcome Occurrence of seizure Within 30 days post-vaccination for vaccine doses administered at 6, 7.5 and 27 months of age (Visits 2, 3 and 10 for Coad and RTS,S group) and at 10.5, 11.5, 12.5 and 30 months of age (Visits 6, 7, 8 and 12 for Control group) or 42 days post-vaccination for vaccine doses administered at 9 months of age (Visit 4 for all groups)
Secondary Outcome Occurrence of generalized convulsive seizure Within 7 days after vaccines administered at Visit 2 and 3 (Coad and RTS,S groups) and 14 days after vaccines administered at Visit 4 (all groups)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Malaria Vaccine Trial Centre P.O.Box 1934 Agogo Ghana
Kintampo Health Research Centre P.O.Box 200 Kintampo Ghana
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 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 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 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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information