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: May 24, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of subjects with serious adverse events [ Time Frame: Up to 8 months post-dose 1 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 327
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (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
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323972     History of Changes
Other Study ID Numbers: 113398
Study First Received: February 24, 2011
Last Updated: May 24, 2012
Health Authority: Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)

Keywords provided by GlaxoSmithKline:
Malaria
Plasmodium falciparum

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 23, 2014