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

NCT00360230 | Completed Phase 2 Results

• 1 other identifier: 106367
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 2

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.

Conditions

Malaria

Keywords

Vaccine; Prophylaxis Plasmodium falciparum malaria; Plasmodium falciparum; Malaria

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serious Adverse Events (SAEs)

  Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  From Day 0 to Month 10

Secondary Outcomes (5)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses

• Number of Subjects With Any Unsolicited Adverse Events (AEs)

  During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses

• Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)

  At Day 0, at Month 2, at Month 7 and at Month 10

• Titers for Anti-Hepatitis B (Anti-HBs)

  At Day 0 and at Month 2

Study Arms (7)

SB257049 F2 0-1 M Group

EXPERIMENTAL

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.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F1 0-1 M Group

EXPERIMENTAL

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.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F2 0-1-2 M Group

EXPERIMENTAL

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.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F1 0-1-2 M Group

EXPERIMENTAL

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.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F2 0-1-7 M Group

EXPERIMENTAL

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.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F1 0-1-7 M Group

ACTIVE COMPARATOR

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.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Rabipur 0-1-2 M Group

ACTIVE COMPARATOR

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.

Biological: Rabipur

Interventions

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 BIOLOGICAL

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

Also known as: RTS, S vaccine

SB257049 F1 0-1 M Group; SB257049 F1 0-1-2 M Group; SB257049 F1 0-1-7 M Group; SB257049 F2 0-1 M Group; SB257049 F2 0-1-2 M Group; SB257049 F2 0-1-7 M Group

Rabipur BIOLOGICAL

3-dose intramuscular injection.

Rabipur 0-1-2 M Group

Eligibility Criteria

• Age: 5 Months - 17 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Kintampo, Ghana

Location

GSK Investigational Site

Kumasi, Ghana

Location

Related Publications (2)

• 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.

  PMID: 21556142 BACKGROUND

• 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.

  PMID: 19806184 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2006
• First Posted: August 4, 2006
• Study Start: August 30, 2006
• Primary Completion: August 25, 2007
• Study Completion: May 30, 2008
• Last Updated: February 19, 2018
• Results First Posted: February 19, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GH (2)