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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 3

Locations

Nigeria

Study Type

Interventional

Intervention

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria, Plasmodium falciparum

Eligibility Criteria

5 Months - 17 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

GSK 257049-Lot 1 Group

GSK 257049-Lot 2 Group

GSK 257049-Lot 3 Group

GSK 257049-Pilot Group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Anti-Circumsporozoite (Anti-CS) Antibody Titers

Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

Secondary Outcome Measures

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).

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.

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.

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.

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.

Full Information

NCT ID

NCT01323972

First Posted

February 24, 2011

Last Updated

June 22, 2018

Sponsor

GlaxoSmithKline

Collaborators

The PATH Malaria Vaccine Initiative (MVI)

1. Study Identification

Unique Protocol Identification Number

NCT01323972

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

May 16, 2011 (Actual)

Primary Completion Date

November 22, 2011 (Actual)

Study Completion Date

May 4, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

The PATH Malaria Vaccine Initiative (MVI)

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Malaria, Plasmodium falciparum

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

327 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK 257049-Lot 1 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK 257049-Lot 2 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK 257049-Lot 3 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK 257049-Pilot Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

Intervention Description

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

Primary Outcome Measure Information:

Title

Anti-Circumsporozoite (Anti-CS) Antibody Titers

Description

Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

Time Frame

One month post-dose 3 (Month 3)

Secondary Outcome Measure Information:

Title

Anti-hepatitis B (Anti-HB) Antibody Concentrations

Description

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Time Frame

One month post-dose 3 (Month 3)

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses

Title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses

Title

Number of Subjects With Unsolicited Adverse Events

Description

Time Frame

Within the 30-day (Days 0-29) post-vaccination period

Title

Number of Subjects With Serious Adverse Events

Description

Time Frame

Up to 8 months post-dose 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Months

Maximum Age & Unit of Time

17 Months

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Enugu

Country

Nigeria

Facility Name

GSK Investigational Site

City

Jos

Country

Nigeria

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113398

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113398

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113398

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113398

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113398

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113398

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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