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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01439360
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : March 8, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
Biological: Havrix Junior
Biological: Prevenar 13
Biological: Varivax/ProVarivax
Biological: Varilrix
Enrollment 12046
Recruitment Details  
Pre-assignment Details Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF) and 7 subjects did not receive any study vaccine despite being allocated a subject number, hence only 12018 subjects started this study.
Arm/Group Title D-QIV Control
Hide Arm/Group Description Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Period Title: Overall Study
Started 6006 6012
Completed 5808 5804
Not Completed 198 208
Reason Not Completed
Adverse Event             4             16
Lost to Follow-up             43             58
Others             10             5
Protocol Violation             1             0
Withdrawal by Subject             140             129
Arm/Group Title D-QIV Control Total
Hide Arm/Group 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 ®). Total of all reporting groups
Overall Number of Baseline Participants 6006 6012 12018
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 6006 participants 6012 participants 12018 participants
21.9  (8.0) 21.8  (8.0) 21.9  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6006 participants 6012 participants 12018 participants
Female
2933
  48.8%
2925
  48.7%
5858
  48.7%
Male
3073
  51.2%
3087
  51.3%
6160
  51.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6006 participants 6012 participants 12018 participants
African Heritage / African American 24 20 44
Asian - Central/South Asian Heritage 1062 1053 2115
Asian - East Asian Heritage 2 0 2
Asian - Japanese Heritage 2 0 2
Asian - South East Asian Heritage 1661 1666 3327
Native Hawaiian or Other Pacific Islander 3 0 3
Other 1639 1642 3281
White - Arabic / North African Heritage 142 149 291
White - Caucasian / European Heritage 1471 1482 2953
1.Primary Outcome
Title Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
90
   1.6%
242
   4.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-QIV, Control
Comments The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (>) 25%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Adjusted for age category and stratified for cohort.
Method of Estimation Estimation Parameter Vaccine efficacy (VE)
Estimated Value 63.2
Confidence Interval (2-Sided) 97.5%
51.8 to 72.3
Estimation Comments VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.
2.Primary Outcome
Title Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
344
   6.0%
662
  11.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-QIV, Control
Comments The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments Adjusted for age category and stratified for cohort
Method of Estimation Estimation Parameter Vaccine efficacy (VE)
Estimated Value 49.8
Confidence Interval (2-Sided) 97.5%
41.8 to 56.8
Estimation Comments VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.
3.Secondary Outcome
Title Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
28
   0.5%
61
   1.1%
4.Secondary Outcome
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.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
20
   0.4%
88
   1.5%
5.Secondary Outcome
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
88
   1.5%
216
   3.8%
6.Secondary Outcome
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.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
79
   1.4%
216
   3.8%
7.Secondary Outcome
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.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
303
   5.3%
602
  10.6%
8.Secondary Outcome
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.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
12
   0.2%
28
   0.5%
9.Secondary Outcome
Title Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5707 5697
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.0%
3
   0.1%
10.Secondary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 753 579
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1, PRE Number Analyzed 744 participants 567 participants
11.9
(10.6 to 13.2)
11.9
(10.5 to 13.5)
H1N1, POST Number Analyzed 752 participants 578 participants
165.3
(148.6 to 183.8)
12.6
(11.1 to 14.3)
H3N2, PRE Number Analyzed 746 participants 568 participants
14.8
(13.2 to 16.5)
13.4
(11.8 to 15.2)
H3N2, POST Number Analyzed 753 participants 578 participants
132.1
(119.1 to 146.5)
14.7
(12.9 to 16.7)
Victoria, PRE Number Analyzed 745 participants 567 participants
10.0
(9.1 to 11.0)
9.2
(8.3 to 10.1)
Victoria, POST Number Analyzed 750 participants 579 participants
92.6
(82.3 to 104.1)
9.2
(8.4 to 10.1)
Yamagata, PRE Number Analyzed 745 participants 568 participants
7.3
(6.8 to 7.8)
7.3
(6.8 to 7.9)
Yamagata, POST Number Analyzed 753 participants 579 participants
121.4
(110.1 to 133.8)
7.6
(7.0 to 8.3)
11.Secondary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 753 579
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, PRE
200
  26.6%
152
  26.3%
H1N1, POST
728
  96.7%
170
  29.4%
H3N2, PRE
266
  35.3%
187
  32.3%
H3N2, POST
740
  98.3%
210
  36.3%
Victoria, PRE
205
  27.2%
138
  23.8%
Victoria, POST
701
  93.1%
147
  25.4%
Yamagata, PRE
134
  17.8%
93
  16.1%
Yamagata, POST
719
  95.5%
108
  18.7%
12.Secondary Outcome
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)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 746 568
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1
596
  79.9%
20
   3.5%
H3N2
513
  68.8%
24
   4.2%
Victoria
514
  68.9%
5
   0.9%
Yamagata
605
  81.1%
13
   2.3%
13.Secondary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 746 568
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
H1N1
14
(12.8 to 15.3)
1.1
(1.0 to 1.1)
H3N2
9.0
(8.2 to 9.8)
1.1
(1.0 to 1.2)
Victoria
9.3
(8.6 to 10.2)
1.0
(1.0 to 1.1)
Yamagata
16.7
(15.2 to 18.3)
1.1
(1.0 to 1.1)
14.Secondary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 753 579
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, PRE
182
  24.2%
134
  23.1%
H1N1, POST
640
  85.0%
146
  25.2%
H3N2, PRE
238
  31.6%
159
  27.5%
H3N2, POST
612
  81.3%
175
  30.2%
Victoria, PRE
143
  19.0%
103
  17.8%
Victoria, POST
539
  71.6%
101
  17.4%
Yamagata, PRE
73
   9.7%
59
  10.2%
Yamagata, POST
638
  84.7%
64
  11.1%
15.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5907 5901
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 5899 participants 5896 participants
1015
  17.2%
1047
  17.8%
Grade 3 Pain, Dose 1 Number Analyzed 5899 participants 5896 participants
23
   0.4%
30
   0.5%
Any Redness, Dose 1 Number Analyzed 5899 participants 5896 participants
775
  13.1%
831
  14.1%
Grade 3 Redness, Pain, Dose 1 Number Analyzed 5899 participants 5896 participants
1
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 5899 participants 5896 participants
467
   7.9%
518
   8.8%
Grade 3 Swelling, Dose 1 Number Analyzed 5899 participants 5896 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 5757 participants 5766 participants
808
  14.0%
820
  14.2%
Grade 3 Pain, Dose 2 Number Analyzed 5757 participants 5766 participants
21
   0.4%
21
   0.4%
Any Redness, Dose 2 Number Analyzed 5757 participants 5766 participants
587
  10.2%
631
  10.9%
Grade 3 Redness, Dose 2 Number Analyzed 5757 participants 5766 participants
2
   0.0%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 5757 participants 5766 participants
375
   6.5%
409
   7.1%
Grade 3 Swelling, Dose 2 Number Analyzed 5757 participants 5766 participants
2
   0.0%
3
   0.1%
Any Pain, Across doses Number Analyzed 5907 participants 5901 participants
1350
  22.9%
1375
  23.3%
Grade 3 Pain, Across doses Number Analyzed 5907 participants 5901 participants
42
   0.7%
48
   0.8%
Any Redness, Across doses Number Analyzed 5907 participants 5901 participants
980
  16.6%
1091
  18.5%
Grade 3 Redness, Across doses Number Analyzed 5907 participants 5901 participants
3
   0.1%
0
   0.0%
Any Swelling, Across doses Number Analyzed 5907 participants 5901 participants
665
  11.3%
742
  12.6%
Grade 3 Swelling, Across doses Number Analyzed 5907 participants 5901 participants
2
   0.0%
3
   0.1%
16.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 5908 5901
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness, Dose 1 Number Analyzed 5898 participants 5896 participants
739
  12.5%
829
  14.1%
Grade 3 Drowsiness, Dose 1 Number Analyzed 5898 participants 5896 participants
39
   0.7%
52
   0.9%
Related Drowsiness, Dose 1 Number Analyzed 5898 participants 5896 participants
490
   8.3%
535
   9.1%
Any Irritability, Dose 1 Number Analyzed 5898 participants 5896 participants
955
  16.2%
1029
  17.5%
Grade 3 Irritability, Dose 1 Number Analyzed 5898 participants 5896 participants
42
   0.7%
62
   1.1%
Related Irritability, Dose 1 Number Analyzed 5898 participants 5896 participants
617
  10.5%
669
  11.3%
Any Loss of appetite, Dose 1 Number Analyzed 5898 participants 5896 participants
847
  14.4%
872
  14.8%
Grade 3 Loss of appetite, Dose 1 Number Analyzed 5898 participants 5896 participants
68
   1.2%
60
   1.0%
Related Loss of appetite, Dose 1 Number Analyzed 5898 participants 5896 participants
541
   9.2%
523
   8.9%
Any Fever, Dose 1 Number Analyzed 5898 participants 5896 participants
372
   6.3%
425
   7.2%
Grade 3 Fever, Dose 1 Number Analyzed 5898 participants 5896 participants
78
   1.3%
76
   1.3%
Related Fever, Dose 1 Number Analyzed 5898 participants 5896 participants
243
   4.1%
287
   4.9%
Any Drowsiness, Dose 2 Number Analyzed 5755 participants 5762 participants
519
   9.0%
558
   9.7%
Grade 3 Drowsiness, Dose 2 Number Analyzed 5755 participants 5762 participants
25
   0.4%
24
   0.4%
Related Drowsiness, Dose 2 Number Analyzed 5755 participants 5762 participants
324
   5.6%
361
   6.3%
Any Irritability, Dose 2 Number Analyzed 5755 participants 5762 participants
777
  13.5%
777
  13.5%
Grade 3 Irritability, Dose 2 Number Analyzed 5755 participants 5762 participants
36
   0.6%
52
   0.9%
Related Irritability, Dose 2 Number Analyzed 5755 participants 5762 participants
488
   8.5%
495
   8.6%
Any Loss of appetite, Dose 2 Number Analyzed 5755 participants 5762 participants
652
  11.3%
681
  11.8%
Grade 3 Loss of appetite, Dose 2 Number Analyzed 5755 participants 5762 participants
47
   0.8%
44
   0.8%
Related Loss of appetite, Dose 2 Number Analyzed 5755 participants 5762 participants
378
   6.6%
413
   7.2%
Any Fever, Dose 2 Number Analyzed 5755 participants 5762 participants
336
   5.8%
363
   6.3%
Grade 3 Fever, Dose 2 Number Analyzed 5755 participants 5762 participants
65
   1.1%
70
   1.2%
Related Fever, Dose 2 Number Analyzed 5755 participants 5762 participants
195
   3.4%
215
   3.7%
Any Drowsiness, Across Doses Number Analyzed 5908 participants 5901 participants
1024
  17.3%
1129
  19.1%
Grade 3 Drowsiness, Across Doses Number Analyzed 5908 participants 5901 participants
61
   1.0%
73
   1.2%
Related Drowsiness, Across Doses Number Analyzed 5908 participants 5901 participants
673
  11.4%
738
  12.5%
Any Irritability, Across Doses Number Analyzed 5908 participants 5901 participants
1383
  23.4%
1427
  24.2%
Grade 3 Irritability, Across Doses Number Analyzed 5908 participants 5901 participants
77
   1.3%
107
   1.8%
Related Irritability, Across Doses Number Analyzed 5908 participants 5901 participants
905
  15.3%
940
  15.9%
Any Loss of appetite, Across Doses Number Analyzed 5908 participants 5901 participants
1227
  20.8%
1288
  21.8%
Grade3 Loss of appetite,Across Doses Number Analyzed 5908 participants 5901 participants
111
   1.9%
97
   1.6%
Related Loss of appetite,AcrossDoses Number Analyzed 5908 participants 5901 participants
774
  13.1%
809
  13.7%
Any Fever, Across Doses Number Analyzed 5908 participants 5901 participants
659
  11.2%
732
  12.4%
Grade 3 Fever, Across Doses Number Analyzed 5908 participants 5901 participants
137
   2.3%
141
   2.4%
Related Fever, Across Doses Number Analyzed 5908 participants 5901 participants
413
   7.0%
476
   8.1%
17.Secondary Outcome
Title Duration of Solicited Local Symptoms
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 1015 1047
Median (Full Range)
Unit of Measure: Days
Pain, Dose 1 Number Analyzed 1015 participants 1047 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Pain, Dose 2 Number Analyzed 808 participants 820 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Redness, Dose 1 Number Analyzed 775 participants 831 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Redness, Dose 2 Number Analyzed 587 participants 631 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Swelling, Dose 1 Number Analyzed 467 participants 518 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Swelling, Dose 2 Number Analyzed 375 participants 409 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 2.0)
18.Secondary Outcome
Title Duration of Solicited General Symptoms
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 955 1029
Median (Full Range)
Unit of Measure: Days
Drowsiness, Dose 1 Number Analyzed 739 participants 829 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Drowsiness, Dose 2 Number Analyzed 519 participants 558 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Irritability, Dose 1 Number Analyzed 955 participants 1029 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Irritability, Dose 2 Number Analyzed 777 participants 777 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Loss of appetite, Dose 1 Number Analyzed 847 participants 872 participants
2.0
(1.0 to 4.0)
2.0
(1.0 to 4.0)
Loss of appetite, Dose 2 Number Analyzed 652 participants 681 participants
3.0
(2.0 to 4.0)
2.0
(1.0 to 4.0)
Fever, Dose 1 Number Analyzed 390 participants 438 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Fever, Dose 2 Number Analyzed 347 participants 372 participants
2.0
(1.0 to 3.0)
1.0
(1.0 to 3.0)
19.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 6006 6012
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AEs
2640
  44.0%
2679
  44.6%
Grade 3 unsolicited AEs
160
   2.7%
149
   2.5%
Related unsolicited AEs
106
   1.8%
116
   1.9%
20.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 6006 6012
Measure Type: Count of Participants
Unit of Measure: Participants
Any MAVs
3885
  64.7%
3988
  66.3%
Grade 3 MAVs
200
   3.3%
211
   3.5%
Related MAVs
57
   0.9%
58
   1.0%
21.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 6006 6012
Measure Type: Count of Participants
Unit of Measure: Participants
Any pIMDs
5
   0.1%
0
   0.0%
Grade 3 pIMDs
3
   0.0%
0
   0.0%
Related pIMDs
3
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title D-QIV Control
Hide Arm/Group Description:
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Number of Participants Analyzed 6006 6012
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
217
   3.6%
201
   3.3%
Related SAEs
6
   0.1%
2
   0.0%
Fatal SAEs
1
   0.0%
3
   0.0%
Related fatal SAEs
0
   0.0%
0
   0.0%
Time Frame Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-QIV Control
Hide Arm/Group Description Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
All-Cause Mortality
D-QIV Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
D-QIV Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   217/6006 (3.61%)      201/6012 (3.34%)    
Blood and lymphatic system disorders     
Anaemia   2/6006 (0.03%)  2 3/6012 (0.05%)  3
Hypochromic anaemia   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Hypoplastic anaemia   0/6006 (0.00%)  0 1/6012 (0.02%)  2
Immune thrombocytopenic purpura   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Iron deficiency anaemia   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Lymphadenitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Congenital, familial and genetic disorders     
Phimosis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Gastrointestinal disorders     
Aphthous ulcer   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Constipation   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Diarrhoea   8/6006 (0.13%)  8 9/6012 (0.15%)  9
Gastritis   2/6006 (0.03%)  3 2/6012 (0.03%)  2
Gastrointestinal disorder   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Gastrooesophageal reflux disease   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Ileus   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Inguinal hernia   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Intestinal obstruction   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Intussusception   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Stomatitis   3/6006 (0.05%)  3 0/6012 (0.00%)  0
Vomiting   3/6006 (0.05%)  3 0/6012 (0.00%)  0
General disorders     
Drowning   1/6006 (0.02%)  1 2/6012 (0.03%)  2
Oedema peripheral   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Pyrexia   4/6006 (0.07%)  4 4/6012 (0.07%)  4
Immune system disorders     
Anaphylactic shock   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Hypersensitivity   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Infections and infestations     
Abscess   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Abscess limb   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Acarodermatitis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Amoebiasis   3/6006 (0.05%)  3 3/6012 (0.05%)  3
Amoebic dysentery   8/6006 (0.13%)  8 3/6012 (0.05%)  3
Appendicitis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Ascariasis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Atypical pneumonia   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Bacterial infection   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Bacterial pyelonephritis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Bronchiolitis   7/6006 (0.12%)  7 6/6012 (0.10%)  7
Bronchitis   11/6006 (0.18%)  12 9/6012 (0.15%)  9
Chest wall abscess   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Chikungunya virus infection   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Cholera   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Conjunctivitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Croup infectious   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Dengue fever   2/6006 (0.03%)  2 10/6012 (0.17%)  10
Diarrhoea infectious   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Dysentery   0/6006 (0.00%)  0 2/6012 (0.03%)  2
Enterovirus infection   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Escherichia pyelonephritis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Escherichia urinary tract infection   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Exanthema subitum   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Gastroenteritis   27/6006 (0.45%)  27 19/6012 (0.32%)  20
Gastroenteritis norovirus   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Gastroenteritis rotavirus   5/6006 (0.08%)  6 8/6012 (0.13%)  8
Gastroenteritis shigella   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Gastroenteritis viral   4/6006 (0.07%)  4 2/6012 (0.03%)  2
Hand-foot-and-mouth disease   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Hepatitis a   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Infection   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Infectious mononucleosis   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Influenza   0/6006 (0.00%)  0 2/6012 (0.03%)  2
Laryngitis   4/6006 (0.07%)  4 1/6012 (0.02%)  1
Lower respiratory tract infection   6/6006 (0.10%)  6 3/6012 (0.05%)  3
Mastoiditis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Meningitis viral   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Mycoplasma infection   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Nasopharyngitis   2/6006 (0.03%)  2 1/6012 (0.02%)  1
Otitis media   4/6006 (0.07%)  4 1/6012 (0.02%)  1
Otitis media acute   1/6006 (0.02%)  1 2/6012 (0.03%)  2
Parasitic gastroenteritis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Periorbital cellulitis   3/6006 (0.05%)  3 1/6012 (0.02%)  1
Peritonsillar abscess   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Pharyngitis   2/6006 (0.03%)  2 5/6012 (0.08%)  5
Pharyngotonsillitis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Pneumonia   56/6006 (0.93%)  60 66/6012 (1.10%)  71
Pneumonia bacterial   0/6006 (0.00%)  0 1/6012 (0.02%)  2
Pneumonia measles   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Pneumonia mycoplasmal   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Pneumonia respiratory syncytial viral   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Pneumonia viral   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Pyelonephritis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Respiratory syncytial virus bronchiolitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Respiratory tract infection   0/6006 (0.00%)  0 2/6012 (0.03%)  2
Rotavirus infection   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Sepsis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Sinusitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Tonsillitis   2/6006 (0.03%)  2 2/6012 (0.03%)  2
Tuberculosis   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Typhoid fever   1/6006 (0.02%)  1 3/6012 (0.05%)  3
Upper respiratory tract infection   4/6006 (0.07%)  4 3/6012 (0.05%)  3
Urinary tract infection   4/6006 (0.07%)  4 4/6012 (0.07%)  4
Varicella   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Viral infection   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Viral rash   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Viral rhinitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Viral sepsis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Wound infection   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Injury, poisoning and procedural complications     
Accidental exposure to product   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Accidental poisoning   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Animal bite   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Burns second degree   1/6006 (0.02%)  1 2/6012 (0.03%)  2
Chemical poisoning   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Concussion   2/6006 (0.03%)  2 1/6012 (0.02%)  1
Foreign body   0/6006 (0.00%)  0 2/6012 (0.03%)  2
Foreign body aspiration   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Head injury   1/6006 (0.02%)  1 2/6012 (0.03%)  2
Laceration   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Near drowning   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Pelvic fracture   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Thermal burn   2/6006 (0.03%)  2 1/6012 (0.02%)  1
Wound   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Investigations     
Blood electrolytes abnormal   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration   8/6006 (0.13%)  9 7/6012 (0.12%)  7
Hypoglycaemia   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Hypokalaemia   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Malnutrition   2/6006 (0.03%)  2 0/6012 (0.00%)  0
Polydipsia   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Nervous system disorders     
Facial paralysis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Febrile convulsion   13/6006 (0.22%)  14 16/6012 (0.27%)  16
Seizure   3/6006 (0.05%)  3 2/6012 (0.03%)  2
Seizure anoxic   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Status epilepticus   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Renal and urinary disorders     
Cystitis haemorrhagic   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Nephrotic syndrome   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Reproductive system and breast disorders     
Balanoposthitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Testicular pain   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Respiratory, thoracic and mediastinal disorders     
Adenoidal hypertrophy   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Apnoea   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Asthma   6/6006 (0.10%)  10 8/6012 (0.13%)  8
Asthmatic crisis   5/6006 (0.08%)  5 2/6012 (0.03%)  2
Atelectasis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Bronchial hyperreactivity   3/6006 (0.05%)  3 2/6012 (0.03%)  2
Bronchial obstruction   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Bronchospasm   4/6006 (0.07%)  4 10/6012 (0.17%)  10
Cough   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Dyspnoea   1/6006 (0.02%)  1 1/6012 (0.02%)  1
Pleural effusion   0/6006 (0.00%)  0 1/6012 (0.02%)  1
Pneumonitis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Wheezing   3/6006 (0.05%)  3 1/6012 (0.02%)  1
Skin and subcutaneous tissue disorders     
Urticaria   0/6006 (0.00%)  0 2/6012 (0.03%)  2
Vascular disorders     
Hypertension   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Venous thrombosis   1/6006 (0.02%)  1 0/6012 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
D-QIV Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3427/6006 (57.06%)      3501/6012 (58.23%)    
General disorders     
Pain   1351/6006 (22.49%)  1824 1376/6012 (22.89%)  1868
Pyrexia   866/6006 (14.42%)  954 949/6012 (15.79%)  1042
Swelling   665/6006 (11.07%)  842 743/6012 (12.36%)  928
Infections and infestations     
Nasopharyngitis   871/6006 (14.50%)  1050 943/6012 (15.69%)  1111
Upper respiratory tract infection   522/6006 (8.69%)  629 516/6012 (8.58%)  609
Metabolism and nutrition disorders     
Decreased appetite   1230/6006 (20.48%)  1504 1293/6012 (21.51%)  1561
Nervous system disorders     
Somnolence   1025/6006 (17.07%)  1259 1129/6012 (18.78%)  1388
Psychiatric disorders     
Irritability   1385/6006 (23.06%)  1734 1428/6012 (23.75%)  1808
Skin and subcutaneous tissue disorders     
Erythema   983/6006 (16.37%)  1365 1094/6012 (18.20%)  1467
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01439360    
Other Study ID Numbers: 115345
2011-000758-41 ( EudraCT Number )
First Submitted: September 21, 2011
First Posted: September 23, 2011
Results First Submitted: December 22, 2016
Results First Posted: March 8, 2017
Last Update Posted: September 26, 2018