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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00360230
First received: July 31, 2006
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Plasmodium Falciparum
Malaria
Biological: Rabipur
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of SAEs. [ Time Frame: From the time of first vaccination until ten months post Dose 1. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of solicited general and local reactions. [ Time Frame: Over a 7 day follow-up period after each vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms. [ Time Frame: After each vaccination over a 30-day follow-up period ] [ Designated as safety issue: Yes ]
  • Antibody titers to the P. falciparum circumsporozoite (CS) repeat domain [ Time Frame: Prior to vaccination until ten months post Dose 1. ] [ Designated as safety issue: No ]
  • Anti-hepatitis B surface antigen (anti-HBs) antibody titers. [ Time Frame: Prior to vaccination and one month post final vaccine dose. ] [ Designated as safety issue: No ]

Enrollment: 540
Study Start Date: August 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group D
Three-dose vaccination schedule (0, 1, 2 month) with RTS,S/AS02D (at Kumasi-KCCR/SMS).
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Other Name: RTS,S vaccine
Active Comparator: Group B
Two-dose vaccination schedule (0,1 month) with RTS,S/AS02D administration.
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Other Name: RTS,S vaccine
Active Comparator: Group F
Alternative 3-dose vaccination schedule (0, 1, 7 month) with RTS,S/AS02D administration.
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Other Name: RTS,S vaccine
Experimental: Group C
Three-dose vaccination schedule (0, 1, 2 month) with RTS,S/AS01E administration.
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Other Name: RTS,S vaccine
Experimental: Group E
Alternative 3-dose vaccination (0, 1, 7 month) schedule with RTS,S/AS01E administration.
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Other Name: RTS,S vaccine
Experimental: Group A
Two-dose vaccination schedule (0, 1 month) with RTS,S/AS01E administration.
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Other Name: RTS,S vaccine
Active Comparator: Group G
Three-dose vaccination schedule (0, 1, 2 month) with Chiron's Rabies vaccine Rabipur (at Kintampo-KHRC only) administration
Biological: Rabipur
3-dose intramuscular injection.

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.

  Eligibility

Ages Eligible for Study:   5 Months to 17 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360230

Locations
Ghana
GSK Investigational Site
Kintampo, Ghana
GSK Investigational Site
Kumasi, Ghana
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00360230     History of Changes
Other Study ID Numbers: 106367
Study First Received: July 31, 2006
Last Updated: September 3, 2009
Health Authority: Ghana: Health Services
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Malaria
Plasmodium falciparum
Vaccine
Prophylaxis Plasmodium falciparum malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 01, 2014