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

GlaxoSmithKline1 site in 1 country540 target enrollmentAugust 30, 2006

ConditionsMalaria

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Malaria
Sponsor: GlaxoSmithKline
Enrollment: 540
Locations: 1
Primary Endpoint: Number of Subjects With Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 30, 2006

End Date

May 30, 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Number of Subjects With Serious Adverse Events (SAEs)

Time Frame: From Day 0 to Month 10

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.

Secondary Outcomes

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 Unsolicited Adverse Events (AEs)(During the 30-day (Days 0 - 29) 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)
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)