Immunogenicity & safety of GSK Biologicals malaria vaccine given at 6,7.5 &9 months of age coadministered with measles,rubella & yellow fever vaccines

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201602001483150
• Date of registration: 23/02/2016
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• 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
• 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
• Date of first enrolment: 14/09/2016
• Target sample size: 700
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1483
• Study type: Interventional
• Study design: 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
• Phase: Not Applicable

Countries of recruitment

Ghana

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: Clinical Disclosure Advisor

• Name: Clinical Disclosure Advisor
• Affiliation: Clinical Disclosure Advisor

Key inclusion & exclusion criteria

Inclusion criteria: ¿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.

Exclusion criteria: ¿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

Age minimum: 6 Month(s)
Age maximum: 6 Month(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Paediatrics

Malaria

Paediatrics

Intervention(s)

Vitamin A

Candidate Plasmodium falciparum malaria vaccine

MR-Vac

Stamaril

Primary Outcome(s)

Anti-CS antibody titers

Secondary Outcome(s)

Anti-Rubella antibody titers and seropositivity

Occurrence of pIMDs

Occurrence of generalized convulsive seizure

Occurrence of any, fatal and related SAEs

Seroconversion for anti-Rubella antibodies

Anti-Measles antibody titers and seropositivity

Occurrence of meningitis

Solicited local and general AEs

Occurrence of any, fatal and related serious adverse events (SAEs)

Anti-YF antibody titers and seropositivity

Unsolicited adverse events (AEs)

Occurrence of seizure

Anti-CS and anti-HBs antibody titers and seropositivity

Seroconversion for anti-Measles antibodies

Secondary ID(s)

200596

Source(s) of Monetary Support

GlaxoSmithKline

Ethics review

Status: Approved
Approval date: 17/11/2015
Contact:

Kintampo Health Research Centre