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An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
Havrix Junior
Prevenar 13
Varivax/ProVarivax
Varilrix
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Vaccine, Seasonal Flu, Efficacy, Children

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
  • Written informed consent obtained from the parent(s) /LAR(s) of the subject.
  • Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Participation in a previous FLU-D-QIV-004 study (115345) cohort.
  • 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 influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
  • Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
  • Any contraindication to intramuscular injection.
  • Acute disease and/or fever at the time of enrolment.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
  • Additional criteria for children ≥ 12 months of age:

    • Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.

      * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.

    • Any history of hepatitis A or varicella diseases.
  • Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:

    • Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

D-QIV

Control

Arm Description

Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).

In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

Outcomes

Primary Outcome Measures

Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Secondary Outcome Measures

Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)
Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).
MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.
Duration of Solicited Local Symptoms
Duration was defined as number of days with any grade of local symptoms.
Duration of Solicited General Symptoms
Duration was defined as number of days with any grade of general symptoms.
Number of Subjects Reporting 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)
MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.

Full Information

First Posted
September 21, 2011
Last Updated
August 30, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01439360
Brief Title
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Official Title
An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2011 (Actual)
Primary Completion Date
October 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Vaccine, Seasonal Flu, Efficacy, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
12046 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-QIV
Arm Type
Experimental
Arm Description
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Intervention Type
Biological
Intervention Name(s)
Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Havrix Junior
Intervention Description
Intramuscular injection administered to subjects aged 12 months or older
Intervention Type
Biological
Intervention Name(s)
Prevenar 13
Intervention Description
Intramuscular injection administered to subjects less than 12 months of age
Intervention Type
Biological
Intervention Name(s)
Varivax/ProVarivax
Intervention Description
Intramuscular injection administered to subjects more than 12 months of age
Intervention Type
Biological
Intervention Name(s)
Varilrix
Intervention Description
Subcutaneous injection administered to subjects more than 12 months of age
Primary Outcome Measure Information:
Title
Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Secondary Outcome Measure Information:
Title
Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Title
Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.
Description
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time Frame
During the surveillance period (approximately 6 to 8 months)
Title
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)
Description
Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Time Frame
At Days 0 and 28/56
Title
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Description
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
Time Frame
At Day 0 and Day 28/56
Title
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Description
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Time Frame
At Day 28/56 (POST)
Title
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).
Description
MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
Time Frame
At Day 28/56 (POST)
Title
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Description
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Time Frame
At Day 0 and Day 28/56
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.
Time Frame
During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Description
Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.
Time Frame
During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Title
Duration of Solicited Local Symptoms
Description
Duration was defined as number of days with any grade of local symptoms.
Time Frame
During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Title
Duration of Solicited General Symptoms
Description
Duration was defined as number of days with any grade of general symptoms.
Time Frame
During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time Frame
During the 28-day (Days 0-27) post-vaccination period
Title
Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)
Description
MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.
Time Frame
During the entire study period (approximately 6- 8 months per subject)
Title
Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).
Description
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.
Time Frame
During the entire study period (approximately 6- 8 months per subject)
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Description
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
During the entire study period (approximately 6- 8 months per subject)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination. Written informed consent obtained from the parent(s) /LAR(s) of the subject. Subjects in stable health as determined by medical history and clinical examination before entering into the study. Exclusion Criteria: Participation in a previous FLU-D-QIV-004 study (115345) cohort. 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 influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country. Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination. Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination. Any contraindication to intramuscular injection. Acute disease and/or fever at the time of enrolment. Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study. Additional criteria for children ≥ 12 months of age: Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted. * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination. Any history of hepatitis A or varicella diseases. Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine: Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
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
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
GSK Investigational Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
GSK Investigational Site
City
Roeselaere
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GSK Investigational Site
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
GSK Investigational Site
City
Decin
ZIP/Postal Code
405 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Humpolec
ZIP/Postal Code
396 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
37701
Country
Czechia
Facility Name
GSK Investigational Site
City
Liberec
ZIP/Postal Code
46015
Country
Czechia
Facility Name
GSK Investigational Site
City
Lipnik nad Becvou
ZIP/Postal Code
75131
Country
Czechia
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Odolena voda
ZIP/Postal Code
25070
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava - Poruba
ZIP/Postal Code
70800
Country
Czechia
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
1600
Country
Czechia
Facility Name
GSK Investigational Site
City
Tabor
ZIP/Postal Code
390 02
Country
Czechia
Facility Name
GSK Investigational Site
City
Santo Domingo, Distrito Nacional
Country
Dominican Republic
Facility Name
GSK Investigational Site
City
Santo Domingo
Country
Dominican Republic
Facility Name
GSK Investigational Site
City
San Pedro Sula
Country
Honduras
Facility Name
GSK Investigational Site
City
Tegucigalpa
Country
Honduras
Facility Name
GSK Investigational Site
City
Faridabad
ZIP/Postal Code
121004
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411 011
Country
India
Facility Name
GSK Investigational Site
City
Pune
Country
India
Facility Name
GSK Investigational Site
City
Beirut
ZIP/Postal Code
1107-2020
Country
Lebanon
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Manila
Country
Philippines
Facility Name
GSK Investigational Site
City
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
GSK Investigational Site
City
Quezon City
ZIP/Postal Code
1113
Country
Philippines
Facility Name
GSK Investigational Site
City
Sampaloc, Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-316
Country
Poland
Facility Name
GSK Investigational Site
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
84-462
Country
Poland
Facility Name
GSK Investigational Site
City
Grudziadz
ZIP/Postal Code
86-330
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-018
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-129
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-223
Country
Poland
Facility Name
GSK Investigational Site
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
GSK Investigational Site
City
Oborniki
ZIP/Postal Code
55-120
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-709
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
62-064
Country
Poland
Facility Name
GSK Investigational Site
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
GSK Investigational Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
GSK Investigational Site
City
Torun
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
00-315
Country
Poland
Facility Name
GSK Investigational Site
City
Wola
ZIP/Postal Code
43-225
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
52-312
Country
Poland
Facility Name
GSK Investigational Site
City
Antequera/Málaga
ZIP/Postal Code
29200
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08042
Country
Spain
Facility Name
GSK Investigational Site
City
Blanes (Girona)
ZIP/Postal Code
17300
Country
Spain
Facility Name
GSK Investigational Site
City
Boadilla del Monte
ZIP/Postal Code
28660
Country
Spain
Facility Name
GSK Investigational Site
City
Castellón
ZIP/Postal Code
12004
Country
Spain
Facility Name
GSK Investigational Site
City
Castellón
ZIP/Postal Code
12530
Country
Spain
Facility Name
GSK Investigational Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28700
Country
Spain
Facility Name
GSK Investigational Site
City
Pozuelo De Alarcón/Madrid
ZIP/Postal Code
28224
Country
Spain
Facility Name
GSK Investigational Site
City
Quart De Poblet, Valencia
ZIP/Postal Code
46930
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41927
Country
Spain
Facility Name
GSK Investigational Site
City
Torrelodones (Madrid)
ZIP/Postal Code
28250
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46011
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46024
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46200
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46702
Country
Spain
Facility Name
GSK Investigational Site
City
Vic/ Barcelona
ZIP/Postal Code
08500
Country
Spain
Facility Name
GSK Investigational Site
City
Xativa/Valencia
ZIP/Postal Code
46800
Country
Spain
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
GSK Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
GSK Investigational Site
City
Bursa
Country
Turkey
Facility Name
GSK Investigational Site
City
Eskisehir
Country
Turkey
Facility Name
GSK Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
GSK Investigational Site
City
St Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7RL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Axbridge
State/Province
Somerset
ZIP/Postal Code
BS26 2BJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Yeovil
State/Province
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Atherstone
State/Province
Warwickshire
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV6 4DD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bolton, Nr Manchester
ZIP/Postal Code
BL3 6TL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Co Antrim
ZIP/Postal Code
BT41 3AE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Crumpsall, Manchester
ZIP/Postal Code
M8 9JT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2QW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Taunton, Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Westminster Bridge Road
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com
Citations:
PubMed Identifier
35083365
Citation
Danier J, Callegaro A, Soni J, Carmona A, Kosalaraska P, Rivera L, Friel D, Pu W, Vantomme V, Dbaibo G, Innis BL, Schuind A, Zaman K, Wilson J. Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction-Confirmed Influenza Illness in Children 6-35 Months of Age: Statistical Evaluation of a Correlate of Protection. Open Forum Infect Dis. 2021 Sep 25;9(2):ofab477. doi: 10.1093/ofid/ofab477. eCollection 2022 Feb.
Results Reference
derived
PubMed Identifier
31725115
Citation
Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL; Flu4VEC Study Group. Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial. Pediatr Infect Dis J. 2020 Jan;39(1):e1-e10. doi: 10.1097/INF.0000000000002504.
Results Reference
derived
PubMed Identifier
31306399
Citation
Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, Innis BL; Flu4VEC Study Group. Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine. Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387.
Results Reference
derived
PubMed Identifier
30325891
Citation
Claeys C, Chandrasekaran V, Garcia-Sicilia J, Prymula R, Diez-Domingo J, Brzostek J, Mares-Bermudez J, Martinon-Torres F, Pollard AJ, Ruzkova R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, Jain VK. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children. Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217.
Results Reference
derived
Links:
URL
https://clinicalstudydatarequest.com
Description
IPD for this study will be made available via the Clinical Study Data Request site.

Learn more about this trial

An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

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