Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children

NCT ID: NCT01323972

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-16
• Study Completion Date: 2012-05-04

Brief Summary

The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GSK 257049-Lot 1 Group

Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

Intervention Type: BIOLOGICAL

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

GSK 257049-Lot 2 Group

Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

Intervention Type: BIOLOGICAL

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

GSK 257049-Lot 3 Group

Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

Intervention Type: BIOLOGICAL

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

GSK 257049-Pilot Group

Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

Intervention Type: BIOLOGICAL

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

Interventions

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• A male or female child between, and including, 5 and 17 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 child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who have received three documented doses of hepatitis B vaccine.

Exclusion Criteria

• Same sex twins.
• 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.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2.
• Acute disease and/or fever at the time of enrolment
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
• Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Administration of immunoglobulins and/or any blood products within 1 month preceding the first dose of study vaccine or planned administration during the study period.
• Child in care.
• Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The PATH Malaria Vaccine Initiative (MVI)

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Enugu, , Nigeria

GSK Investigational Site

Jos, , Nigeria

Countries

Nigeria

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

113398

Identifier Type: -

Identifier Source: org_study_id