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Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

GSK investigational vaccine GSK1557482A

Fluzone®

About this trial

This is an interventional prevention trial for Influenza focused on measuring GSK Biologicals influenza vaccine GSK1557482A, influenza infection

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
Child in care
Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
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.
History of hypersensitivity to any vaccine.
History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flulaval Group

Fluzone Group

Arm Description

subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.

subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.

Outcomes

Primary Outcome Measures

Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

Secondary Outcome Measures

Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.

Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.

Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.

Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.

Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.

Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.

Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).

The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.

Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).

The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination.

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.

Number of Subjects Reporting Medically Attended Adverse Events (MAEs).

For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.

Number of Subjects Reporting Serious Adverse Events (SAEs).

An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Full Information

NCT ID

NCT00980005

First Posted

September 17, 2009

Last Updated

August 22, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00980005

Brief Title

Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

Official Title

Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 13, 2009 (undefined)

Primary Completion Date

March 2, 2010 (Actual)

Study Completion Date

June 17, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

6. Conditions and Keywords

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

Influenza

Keywords

GSK Biologicals influenza vaccine GSK1557482A, influenza infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flulaval Group

Arm Type

Experimental

Arm Description

Arm Title

Fluzone Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK investigational vaccine GSK1557482A

Intervention Description

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Intervention Type

Biological

Intervention Name(s)

Fluzone®

Intervention Description

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Primary Outcome Measure Information:

Title

Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.

Description

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

Time Frame

At Day 0 and 28 after last vaccine dose.

Title

Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.

Description

Time Frame

At Day 28 after last vaccine dose.

Secondary Outcome Measure Information:

Title

Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.

Description

Time Frame

At Day 0 and 28 after last vaccine dose.

Title

Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.

Description

Time Frame

At Day 28 after last vaccine dose.

Title

Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.

Description

Time Frame

At Day 0 and 28 after last vaccine dose.

Title

Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.

Description

Time Frame

At Day 0 and 28 after last vaccine dose.

Title

Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.

Description

Time Frame

At Day 0 and at Day 28 after last vaccine dose

Title

Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.

Description

Time Frame

At Day 0 and at Day 28 after last vaccine dose

Title

Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).

Description

Time Frame

During a 4-day follow-up period (Days 0-3) after vaccination.

Title

Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).

Description

Time Frame

During a 4-day follow-up period (Days 0-3) after vaccination.

Title

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).

Description

Time Frame

During a 4-day follow-up period (Days 0-3) after vaccination.

Title

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.

Description

Time Frame

During a 4-day follow-up period (Days 0-3) after vaccination.

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).

Description

Time Frame

During a 28 day follow-up period (Days 0-27) after vaccination.

Title

Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.

Description

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.

Time Frame

During a 28 day follow-up period (Days 0-27) after vaccination.

Title

Number of Subjects Reporting Medically Attended Adverse Events (MAEs).

Description

Time Frame

During the entire study period (From Day 0 up to Day 180).

Title

Number of Subjects Reporting Serious Adverse Events (SAEs).

Description

Time Frame

During the entire study period (From Day 0 up to Day 180).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol. A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable. Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. Healthy subjects as established by medical history and history-directed clinical examination before entering into the study. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion. Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season. Child in care Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. 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. History of hypersensitivity to any vaccine. History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). Acute disease and/or fever at the time of enrolment. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female. History of chronic alcohol consumption and/or drug abuse. Female planning to become pregnant or planning to discontinue contraceptive precautions. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

GSK Investigational Site

City

Benton

State/Province

Arkansas

ZIP/Postal Code

72015

Country

United States

Facility Name

GSK Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

GSK Investigational Site

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

GSK Investigational Site

City

West Covina

State/Province

California

ZIP/Postal Code

91790

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

Facility Name

GSK Investigational Site

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

GSK Investigational Site

City

DeKalb

State/Province

Illinois

ZIP/Postal Code

60115

Country

United States

Facility Name

GSK Investigational Site

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Woburn

State/Province

Massachusetts

ZIP/Postal Code

01801

Country

United States

Facility Name

GSK Investigational Site

City

Stevensville

State/Province

Michigan

ZIP/Postal Code

49127

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

GSK Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89015

Country

United States

Facility Name

GSK Investigational Site

City

Cortland

State/Province

New York

ZIP/Postal Code

13045

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

GSK Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

GSK Investigational Site

City

Austintown

State/Province

Ohio

ZIP/Postal Code

44515

Country

United States

Facility Name

GSK Investigational Site

City

Albany

State/Province

Oregon

ZIP/Postal Code

97322

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16505

Country

United States

Facility Name

GSK Investigational Site

City

Hermitage

State/Province

Pennsylvania

ZIP/Postal Code

16148

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77055

Country

United States

Facility Name

GSK Investigational Site

City

Orem

State/Province

Utah

ZIP/Postal Code

84057

Country

United States

Facility Name

GSK Investigational Site

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

GSK Investigational Site

City

Burke

State/Province

Virginia

ZIP/Postal Code

22015

Country

United States

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.

Citations:

PubMed Identifier

29465480

Citation

Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.

Results Reference

derived

PubMed Identifier

22333695

Citation

Domachowske JB, Blatter M, Chandrasekaran V, Liu A, Jain VK, Fries L. A randomized, controlled trial in children to assess the immunogenicity and safety of a thimerosal-free trivalent seasonal influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924.

Results Reference

derived

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

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112999

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112999

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

112999

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

112999

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

112999

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

112999

Available IPD/Information Comments

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

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112999

Available IPD/Information Comments

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

Learn more about this trial

Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

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Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

Influenza

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial