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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 25, 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: Quadruple (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:
  • Anti-Circumsporozoite (Anti-CS) Antibody Titers [ Time Frame: One month post-dose 3 (Month 3) ]
    Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.


Secondary Outcome Measures:
  • Anti-hepatitis B (Anti-HB) Antibody Concentrations [ Time Frame: One month post-dose 3 (Month 3) ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects With Unsolicited Adverse Events [ Time Frame: Within the 30-day (Days 0-29) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Serious Adverse Events [ Time Frame: Up to 8 months post-dose 1 ]
    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.


Enrollment: 327
Actual 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: GSK 257049-Lot 1 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
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: GSK 257049-Lot 2 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
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: GSK 257049-Lot 3 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
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: GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
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
Results First Received: April 25, 2017
Last Updated: April 25, 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:
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 September 21, 2017