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Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children

This study has been completed.
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323972
First received: February 24, 2011
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.

Condition Intervention Phase
Malaria
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Consistency of Immunogenicity and Non Inferiority of Three Production Lots of GSK Biologicals' Candidate Malaria Vaccine in Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Lot-to lot consistency for immunogenicity of the investigational vaccine in terms of circumsporozoite protein (CS) antibody titers [ Time Frame: 1 month post-dose 3 (Day 90) ]
  • Non-inferiority of pooled commercial scale lots versus the pilot scale in terms of CS antibody titers [ Time Frame: 1 month post-dose 3 (Day 90) ]

Secondary Outcome Measures:
  • Number of subject with solicited general and local adverse events [ Time Frame: Over a 7 day follow-up period after vaccination (day of vaccination and 6 subsequent days) ]
  • Number of subjects with unsolicited adverse events [ Time Frame: Over a 30 day follow-up period after vaccination (day of vaccination and 29 subsequent days) ]
  • Number of subjects with serious adverse events [ Time Frame: Up to 8 months post-dose 1 ]
  • Evaluation of the immune response to the hepatitis B component of the investigational vaccine, in terms of antibody titers [ Time Frame: 1 month post-dose 3 (Day 90) ]

Enrollment: 327
Study Start Date: May 16, 2011
Study Completion Date: May 4, 2012
Primary Completion Date: November 22, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
Experimental: Group B Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
Experimental: Group C Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
Experimental: Group D Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

  Eligibility

Ages Eligible for Study:   5 Months to 17 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination.
  • Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects who have received three documented doses of hepatitis B vaccine.

Exclusion Criteria:

  • Same sex twins.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures.
  • Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2.
  • Acute disease and/or fever at the time of enrolment
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
  • Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Administration of immunoglobulins and/or any blood products within 1 month preceding the first dose of study vaccine or planned administration during the study period.
  • Child in care.
  • 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: NCT01323972

Locations
Nigeria
GSK Investigational Site
Enugu, Nigeria
GSK Investigational Site
Jos, Nigeria
Sponsors and Collaborators
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113398
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: 113398
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: 113398
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: 113398
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113398
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: 113398
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323972     History of Changes
Other Study ID Numbers: 113398
Study First Received: February 24, 2011
Last Updated: April 6, 2017
Individual Participant Data  
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:
Malaria
Plasmodium falciparum

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

ClinicalTrials.gov processed this record on May 25, 2017