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

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

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.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Phase 3

Contacts and Locations

Study Locations

• Nigeria
  • Enugu, Nigeria
    • GSK Investigational Site
  • Jos, Nigeria
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-Circumsporozoite (Anti-CS) Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.	One month post-dose 3 (Month 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-hepatitis B (Anti-HB) Antibody Concentrations	Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).	One month post-dose 3 (Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.	Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	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.	Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of Subjects With Unsolicited Adverse Events	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.	Within the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events	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.	Up to 8 months post-dose 1

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: The PATH Malaria Vaccine Initiative (MVI)

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2011
• Primary Completion (Actual): November 22, 2011
• Study Completion (Actual): May 4, 2012

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 28, 2011

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Malaria; Plasmodium falciparum
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: 113398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Dataset Specification
   Information identifier: 113398
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 113398
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 113398
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 113398
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 113398
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 113398
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register