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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Quadrivalent seasonal influenza vaccine GSK2282512A

Fluarix™ VB

Fluarix™ YB

Quadrivalent seasonal influenza vaccine GSK2282512A

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza

Eligibility Criteria

6 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
Written informed assent obtained from the subject if/as required by local regulations.
Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
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 urine 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:

Child in care
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
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.
History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Fever at the time of enrolment.
Acute disease at the time of enrolment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Pregnant or lactating female.
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.
Ongoing aspirin therapy.
Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

GSK2282512A 1 Group

Victoria strain Fluarix Group

Yamagata strain Fluarix Group

GSK2282512A 2 Group

Arm Description

Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.

Outcomes

Primary Outcome Measures

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

Number of Subjects Seroconverted Against 4 Strains of Influenza Disease

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

Secondary Outcome Measures

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Number of Subjects Seroprotected Against 4 Strains of Influenza Disease

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata

Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata

Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).

Number of Days With Solicited Local Symptoms After Vaccination

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.

Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.

Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.

Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.

Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.

Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination

Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Unsolicited AE covers any AE 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 unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination

Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination.

Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination

Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

Full Information

NCT ID

NCT01198756

First Posted

September 9, 2010

Last Updated

August 22, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01198756

Brief Title

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Official Title

Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 1, 2010 (undefined)

Primary Completion Date

July 1, 2011 (Actual)

Study Completion Date

July 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

6. Conditions and Keywords

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

Influenza

Keywords

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK2282512A 1 Group

Arm Type

Experimental

Arm Description

Arm Title

Victoria strain Fluarix Group

Arm Type

Active Comparator

Arm Description

Arm Title

Yamagata strain Fluarix Group

Arm Type

Active Comparator

Arm Description

Arm Title

GSK2282512A 2 Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Quadrivalent seasonal influenza vaccine GSK2282512A

Intervention Description

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.

Intervention Type

Biological

Intervention Name(s)

Fluarix™ VB

Intervention Description

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.

Intervention Type

Biological

Intervention Name(s)

Fluarix™ YB

Intervention Description

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose

Intervention Type

Biological

Intervention Name(s)

Quadrivalent seasonal influenza vaccine GSK2282512A

Intervention Description

Single intramuscular dose for primed subjects, two doses for unprimed subjects.

Primary Outcome Measure Information:

Title

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Description

Time Frame

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Number of Subjects Seroconverted Against 4 Strains of Influenza Disease

Description

Time Frame

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Secondary Outcome Measure Information:

Title

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Number of Subjects Seroprotected Against 4 Strains of Influenza Disease

Description

Time Frame

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Description

Time Frame

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata

Description

Time Frame

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata

Description

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

Time Frame

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata

Description

Time Frame

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata

Description

Time Frame

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

Description

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Days With Solicited Local Symptoms After Vaccination

Description

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age

Description

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above

Description

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination

Description

Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.

Time Frame

During the 7-day follow-up period (Days 0-6) after vaccination

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

During the 28-day follow-up period (Day 0-27) after vaccination

Title

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination

Description

Time Frame

During the entire study period (from Day 0 to Day 180)

Title

Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination

Description

Time Frame

During the entire study period (from Day 0 to Day 180)

Title

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

Description

Time Frame

During the entire study period (from Day 0 to Day 180)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol. A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject. Written informed assent obtained from the subject if/as required by local regulations. Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history. 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 urine 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: Child in care Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. 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. History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine. Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. Fever at the time of enrolment. Acute disease at the time of enrolment. Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin. Pregnant or lactating female. 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. Ongoing aspirin therapy. Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

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

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

GSK Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85288

Country

United States

Facility Name

GSK Investigational Site

City

Harrisburg

State/Province

Arkansas

ZIP/Postal Code

72432

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

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

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

GSK Investigational Site

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

GSK Investigational Site

City

Thornton

State/Province

Colorado

ZIP/Postal Code

80233

Country

United States

Facility Name

GSK Investigational Site

City

Niles

State/Province

Michigan

ZIP/Postal Code

49120

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

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

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

Barnwell

State/Province

South Carolina

ZIP/Postal Code

29812

Country

United States

Facility Name

GSK Investigational Site

City

Clarksville

State/Province

Tennessee

ZIP/Postal Code

37043

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76135

Country

United States

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2C8

Country

Canada

Facility Name

GSK Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 8P8

Country

Canada

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

GSK Investigational Site

City

Mount Pearl

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1N 5B6

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

GSK Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 5G8

Country

Canada

Facility Name

GSK Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 1H5

Country

Canada

Facility Name

GSK Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 3H3

Country

Canada

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico city

ZIP/Postal Code

04530

Country

Mexico

Facility Name

GSK Investigational Site

City

Alcala de Guadaira

ZIP/Postal Code

41500

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Pozuelo De Alarcón/Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

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

23847058

Citation

Langley JM, Carmona Martinez A, Chatterjee A, Halperin SA, McNeil S, Reisinger KS, Aggarwal N, Huang LM, Peng CT, Garcia-Sicilia J, Salamanca de la Cueva I, Cabanas F, Trevino-Garza C, Rodriguez-Weber MA, de la O M, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. J Infect Dis. 2013 Aug 15;208(4):544-53. doi: 10.1093/infdis/jit263. Epub 2013 Jul 11. Erratum In: J Infect Dis. 2014 May 1;209(9):1494.

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

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113314

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

113314

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

113314

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

113314

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

113314

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

113314

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

113314

Available IPD/Information Comments

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

Learn more about this trial

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Influenza

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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