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Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00307021
First received: February 16, 2006
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years

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 one month post Dose 3 ]
  • Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS). [ Time Frame: One month post Dose 3. ]

Secondary Outcome Measures:
  • Occurrence of solicited general and local reactions. [ Time Frame: Over a 7-day follow-up period after each vaccination. ]
  • Occurrence of unsolicited symptoms. [ Time Frame: After each vaccination over a 30-day follow-up ]
  • Anti-CS antibody titers. [ Time Frame: Prior to vaccination, one month post Dose 2 ]
  • Anti-Hepatitis B surface agent (anti-HBs) antibody titers. [ Time Frame: Prior to vaccination, one month post Dose 2 and one month post Dose 3. ]

Enrollment: 180
Study Start Date: April 7, 2006
Study Completion Date: August 22, 2007
Primary Completion Date: September 15, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations
Experimental: Group B Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations

  Eligibility

Ages Eligible for Study:   18 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) 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 (e.g. return for follow-up visits)

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 range.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of 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.
  • Previous participation in any other malaria vaccine trial.
  • Simultaneous participation in any other clinical trial.
  • Same sex twin.
  • 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: NCT00307021

Locations
Gabon
GSK Investigational Site
Lambaréné, Gabon
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 105874
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 105874
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 105874
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 105874
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 105874
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 105874
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00307021     History of Changes
Other Study ID Numbers: 105874
Study First Received: February 16, 2006
Last Updated: April 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Parasitic Diseases
Malaria, Falciparum
Malaria
Coccidiosis

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017