Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children

NCT ID: NCT00360230

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-30
• Study Completion Date: 2008-05-30

Brief Summary

This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.

Conditions

Malaria

Study Design

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

Study Groups

SB257049 F2 0-1 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type: BIOLOGICAL

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

SB257049 F1 0-1 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type: BIOLOGICAL

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

SB257049 F2 0-1-2 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type: BIOLOGICAL

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

SB257049 F1 0-1-2 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type: BIOLOGICAL

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

SB257049 F2 0-1-7 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: EXPERIMENTAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type: BIOLOGICAL

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

SB257049 F1 0-1-7 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Intervention Type: BIOLOGICAL

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

Rabipur 0-1-2 M Group

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Group Type: ACTIVE_COMPARATOR

Rabipur

Intervention Type: BIOLOGICAL

3-dose intramuscular injection.

Interventions

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

Intervention Type: BIOLOGICAL

Rabipur

3-dose intramuscular injection.

Intervention Type: BIOLOGICAL

Other Intervention Names

RTS; S vaccine

Eligibility Criteria

Inclusion Criteria

• A male or female child between 5 months and 17 months of age at the time of first vaccination.
• Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.

Exclusion Criteria

• Acute disease at the time of enrolment.
• Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
• Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
• Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
• Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Simultaneous participation in any other clinical trial;
• Previous participation in any other malaria vaccine trial;
• Any twins
• History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• 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

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Kintampo, , Ghana

GSK Investigational Site

Kumasi, , Ghana

Countries

Ghana

References

Ansong D, Asante KP, Vekemans J, Owusu SK, Owusu R, Brobby NA, Dosoo D, Osei-Akoto A, Osei-Kwakye K, Asafo-Adjei E, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Janssens MH, Lievens MJ, Olivier AC, Jongert E, Dubois P, Savarese BM, Cohen J, Antwi S, Greenwood BM, Evans JA, Agbenyega T, Moris PJ, Owusu-Agyei S. T cell responses to the RTS,S/AS01(E) and RTS,S/AS02(D) malaria candidate vaccines administered according to different schedules to Ghanaian children. PLoS One. 2011 Apr 27;6(4):e18891. doi: 10.1371/journal.pone.0018891.

Reference Type: BACKGROUND

PMID: 21556142 (View on PubMed)

Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, Wireko Brobby NA, Dosoo D, Osei Akoto A, Osei-Kwakye K, Adjei EA, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Vekemans J, Ofori-Anyinam O, Leach A, Lievens M, Demoitie MA, Dubois MC, Cohen J, Ballou WR, Savarese B, Chandramohan D, Gyapong JO, Milligan P, Antwi S, Agbenyega T, Greenwood B, Evans J. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009 Oct 2;4(10):e7302. doi: 10.1371/journal.pone.0007302.

Reference Type: BACKGROUND

PMID: 19806184 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

Document Type: Informed Consent Form

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

View Document

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

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Other Identifiers

106367

Identifier Type: -

Identifier Source: org_study_id